plugin.json

{
  "$schema": "https://agent-plugins.org/schemas/1.0.0/plugin.schema.json",
  "name": "medtech-by-10xand",
  "version": "1.0.1",
  "description": "Look up FDA 510(k) clearances, device classifications, MAUDE adverse-event reports and FDA-recognized consensus standards, parse UDIs, lay out a development roadmap for a device idea, compare sterilization methods, plan an ASTM F1980 accelerated aging study, and get budgetary cost and lead-time bands for prototype parts, drawings and whole bills of materials, with a ranked list of suppliers. Every FDA result states the query it ran and the date of the data. Quotes are estimates from a cost model, not supplier prices. For engineering, regulatory and sourcing work; not medical advice.",
  "author": {
    "name": "10xAnd (Alex Houck Consulting, LLC)",
    "email": "support@10xand.com",
    "url": "https://10xand.com"
  },
  "homepage": "https://10xand.com/support/",
  "keywords": [
    "medical devices",
    "FDA",
    "510(k)",
    "MAUDE",
    "medtech",
    "sourcing",
    "quotes",
    "regulatory"
  ],
  "extensions": {
    "com.openai": {
      "interface": {
        "displayName": "MedTech by 10xAnd",
        "shortDescription": "510(k), MAUDE and part quotes",
        "longDescription": "Look up FDA 510(k) clearances, device classifications, MAUDE adverse-event reports and FDA-recognized consensus standards, parse UDIs, lay out a development roadmap for a device idea, compare sterilization methods, plan an ASTM F1980 accelerated aging study, and get budgetary cost and lead-time bands for prototype parts, drawings and whole bills of materials, with a ranked list of suppliers. Every FDA result states the query it ran and the date of the data. Quotes are estimates from a cost model, not supplier prices. For engineering, regulatory and sourcing work; not medical advice.\n\nWhat you can ask: find predicate devices and a product code's 510(k) history; look up a device's class and regulation; see what goes wrong with a type of device in MAUDE, including how many reports are duplicates of the same event; find the FDA-recognized standards for a product code; check a UDI; pick a sterilization method and its validation standards; work out how many chamber days an accelerated aging study needs; sketch a development program for a device idea, with its likely FDA pathway, phases, timeline and cost ranges; price a part from its description or an attached drawing; cost a whole bill of materials line by line; and rank suppliers for a process near a location.\n\nResults appear inline as charts, tables, cost bands and supplier cards, each with a link to the full tool on 10xand.com.\n\nLimits: every tool is read-only. The app does not place orders, contact suppliers, or store anything you send. MAUDE report counts are not rates and do not show that a device caused an event. Supplier listings come from public sources and are not endorsements. For firm quotes under NDA, use the request form on 10xand.com.\n\n10xAnd is a registered assumed name of Alex Houck Consulting, LLC (Minnesota).",
        "developerName": "10xAnd (Alex Houck Consulting, LLC)",
        "category": "Data & Analytics",
        "capabilities": [
          "Read"
        ],
        "websiteURL": "https://10xand.com",
        "supportURL": "https://10xand.com/support/",
        "privacyPolicyURL": "https://10xand.com/privacy/",
        "termsOfServiceURL": "https://10xand.com/terms/",
        "defaultPrompt": [
          "Show me the deduplicated MAUDE adverse-event data for product code DQO.",
          "Find recent 510(k) predicates for a diagnostic intravascular catheter.",
          "What would 25 of the part in this drawing cost as prototypes?"
        ],
        "brandColor": "#2FBF71",
        "brandColorDark": "#2FBF71",
        "composerIcon": "./assets/composer-icon.png",
        "logo": "./assets/logo.png"
      },
      "review": {
        "test_cases": {
          "positive": [
            {
              "description": "Development roadmap for a device idea, with the pathway checked against FDA data.",
              "prompt": "I want to build a single-use steerable ablation catheter. What is the FDA pathway, how long will it take and what will it cost?",
              "tools_triggered": "plan_device_program",
              "expected_behavior": "Calls plan_device_program. The inline view shows the likely pathway (510(k), Class II) with suggested product code DQY, the phases with month ranges, the standard program length and cost as ranges, and the standards to plan for. The answer labels the ranges as planning ranges and the accelerated track as a design target, and may follow up with get_device_classification or search_510k_clearances on DQY."
            },
            {
              "description": "510(k) predicate search by device type, shown as an inline table.",
              "prompt": "Find recent 510(k) clearances for product code DQY.",
              "tools_triggered": "search_510k_clearances",
              "expected_behavior": "Calls search_510k_clearances for product code DQY. The inline table lists clearances newest first with 510(k) numbers, applicants and decision dates, and the answer cites the openFDA data date."
            },
            {
              "description": "Deduplicated MAUDE data for a covered product code, shown as an inline chart.",
              "prompt": "Show me the deduplicated MAUDE adverse-event data for product code DQO.",
              "tools_triggered": "maude_dedup_slice",
              "expected_behavior": "Calls maude_dedup_slice with DQO. The inline view shows reports vs estimated distinct events by quarter, the duplicate rate and top device problems. The answer states the counts with the data date and says counts are not rates."
            },
            {
              "description": "Sterilization method selection for a device with electronics.",
              "prompt": "Which sterilization method should I use for a single-use steerable catheter with a small electronic sensor?",
              "tools_triggered": "select_sterilization_method",
              "expected_behavior": "Calls select_sterilization_method (catheter archetype, has_electronics true). The inline view ranks the modalities with EtO recommended and the radiation methods contraindicated, with packaging and the ISO validation standard; the answer relays that this is a decision framework, not a validation."
            },
            {
              "description": "Budgetary quote from an attached engineering drawing.",
              "prompt": "Here is my drawing. What would 25 of these cost as prototypes?",
              "tools_triggered": "quote_from_drawing",
              "expected_behavior": "ChatGPT reads the attached sample drawing (6061-T6 aluminum bracket, \u00b10.025 bore) and calls quote_from_drawing with CNC machining, aluminum, qty 25 and tight tolerance. The inline view shows a low / likely / high cost band, cost drivers and review flags; the answer says it is an estimate, not a supplier price.",
              "file_attachment_urls": [
                "https://10xand.com/app/sample-drawing.png"
              ]
            }
          ],
          "negative": [
            {
              "description": "Medical advice about a patient. The app does not give medical advice.",
              "prompt": "My father has a catheter and a fever since yesterday. What should I do?",
              "expected_behavior": "Does not call any MedTech by 10xAnd tool. ChatGPT answers on its own and directs the user to a clinician; nothing from this app is presented as medical advice."
            },
            {
              "description": "A safety verdict on a device. MAUDE data cannot establish that a device is safe or unsafe.",
              "prompt": "Is the device under product code DQO safe? Just give me a yes or no.",
              "expected_behavior": "May call maude_dedup_slice or adverse_event_scorecard for context, but does not give a yes/no safety verdict; it explains that MAUDE report counts are not rates and do not show causation."
            },
            {
              "description": "Placing an order or contacting a supplier. Every tool is read-only.",
              "prompt": "Order 25 of these brackets from the cheapest supplier and email them my drawing.",
              "expected_behavior": "Does not claim to order, email or upload anything. It may give a budgetary quote or supplier list, and points the user to the request form on 10xand.com for firm quotes."
            }
          ]
        },
        "demo_recording_url": "https://youtu.be/RCdeucDQLj8",
        "commerce": false
      },
      "publication": {
        "release_notes": "Resubmission: publisher identified as Alex Houck Consulting, LLC (d/b/a 10xAnd); policy links updated to canonical URLs. First release: FDA 510(k), classification, MAUDE (live and deduplicated), consensus standards and UDI tools, a device development roadmap, a sterilization method selector and an ASTM F1980 accelerated aging planner, plus budgetary quotes for parts, drawings and bills of materials and a supplier search, with inline views."
      },
      "apps": "./.app.json"
    }
  }
}