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The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, singleoperator, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator balloon. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Device Performance against Pre-determined Specifications and Acceptance Criteria",
    "headers": ["Test Category", "Test Performed", "Acceptance Criteria", "Reported Device Performance"],
    "rows": [
      ["Biocompatibility", "Biocompatibility Assessment", "Determined in accordance with ISO 10993", "Met"],
      ["Sterilization", "Sterilization testing", "Per ISO 11137-1:2006 and ISO 11137-2:2013", "Met"],
      ["Packaging", "Distribution testing", "Per ASTM D4169", "Met"],
      ["Packaging", "Pouch bubble testing", "Per ASTM F2096", "Met"],
      ["Packaging", "Pouch seal strength testing", "Per ASTM F88/F88M", "Met"],
      ["Labeling", "Label adhesion", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "System fluid delivery rate", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Catheter stiffness", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Actuator inflation and deflation time", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Actuator diameter minimum/maximum", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Actuator integrity after tortuous anatomy", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Actuator burst strength", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Drug line integrity", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Drug line burst strength", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Inflation line leakage under vacuum", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "System leakage under pressure", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Pressure relief valve cracking pressure and leak rate", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Radio-opaque markers intact", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Microneedle sheathing", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Microneedle insertion force at failure", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Microneedle durability", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Microneedle active length", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Actuator retraction force to failure and in vacuum", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Catheter bend kink resistance", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Tensile strength", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Torsional strength", "Not specified in document", "Met"],
      ["Mechanical and Fluid Delivery Performance", "Repetitive function and fatigue", "Not specified in document", "Met"]
    ]
  },
  "study_information": {
    "description": "The Bullfrog Micro-Infusion Device underwent non-clinical performance testing to demonstrate substantial equivalence and safety. This testing included mechanical and fluid delivery performance, biocompatibility, sterilization, and in-vivo safety studies. The testing adopted methodologies from prior versions of the device ([K161402](https://510k.innolitics.com/search/K161402)) for biocompatibility due to no material changes, and functional testing as defined in ISO 10555-1 with Amendments 1 and 2, along with customized testing for performance for changed components.",
    "sample_size_test_set": "Not specified in the provided document. The document refers to 'non-clinical testing of components' and 'Testing performed on the device' without detailing specific sample sizes for each test.",
    "data_provenance": "Not explicitly stated for all tests, but given the nature of the device (medical device) and the regulatory submission, the data is likely from laboratory testing conducted by Mercator MedSystems, Inc. The document refers to 'in-vivo safety studies' but does not provide details on their nature or origin. It is a retrospective summary of testing data for a 510(k) submission.",
    "number_of_experts_ground_truth_test_set": "Not applicable. The reported 'ground truth' or acceptance criteria for non-clinical performance tests are based on established standards (e.g., ISO, ASTM) and internal engineering specifications, not expert consensus on medical images or patient outcomes.",
    "qualifications_experts_ground_truth_test_set": "Not applicable. Ground truth for these non-clinical tests is based on published standards and engineering specifications.",
    "adjudication_method_test_set": "Not applicable. Adjudication methods are typically for clinical studies with subjective interpretations. Non-clinical tests usually have objective pass/fail criteria.",
    "mrmc_comparative_effectiveness_study": "No. The document details non-clinical performance testing of a medical device (catheter), not AI software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or reported.",
    "standalone_algorithm_performance_study": "No. This is a physical medical device, not an algorithm or AI product. References to 'performance data' and 'performance testing' relate to the device's physical and functional attributes.",
    "type_of_ground_truth_used": "Engineering specifications, established international standards (ISO 10993, ISO 10555-1, ISO 11137-1, ISO 11137-2), and American Society for Testing and Materials (ASTM) standards (ASTM D4169, ASTM F2096, ASTM F88/F88M).",
    "sample_size_training_set": "Not applicable. This is a physical device, not an AI model, so there is no 'training set' in the context of machine learning.",
    "how_ground_truth_training_set_established": "Not applicable. There is no training set for this type of device."
  }
}

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