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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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In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally.

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.

This document is a 510(k) summary for the Mercator MedSystems Bullfrog Micro-Infusion Device.

Based on the provided information, no new performance testing was conducted to support substantial equivalence for the current submission (K161402). The document explicitly states: "No new performance testing was conducted to support substantial equivalence, since the predicate and subject devices are identical in terms of technological characteristics."

Therefore, the requested information about acceptance criteria and reported device performance from a new study proving the device meets those criteria for the K161402 submission cannot be extracted from this document because no such new study was performed.

However, the document mentions that performance testing of the predicate device (K153501) was conducted. This predicate device is also the "Bullfrog Micro-Infusion Device" by Mercator MedSystems, implying the subject device is identical to its predicate in design and performance, except for an update in the Indications for Use.

The document states that the predicate device's performance testing included:

• Mechanical and fluid delivery performance
• Biocompatibility
• Sterilization validation
• In-vivo safety and effectiveness studies

It further notes: "All tests met the pre-determined specifications and acceptance criteria."

Since no new study directly addressing acceptance criteria for K161402 is provided, I cannot populate the table or answer the specific questions (2-9) about a study from this application. The information provided pertains to the predicate device's testing, for which details like specific acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies are not included in this 510(k) summary.

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In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The Bullfrog Micro-Infusion Device is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bullfrog Micro-Infusion Device, based only on the input you provided.

Note: The provided document is a 510(k) summary for a medical device. These summaries typically highlight that performance tests were done and met criteria, but they do not usually contain the detailed acceptance criteria or the full study results that would be found in a complete test report or clinical study report. Therefore, much of the requested information (especially specific numerical acceptance criteria, detailed study parameters, and specific quantitative results) is not present in this document.

While the document states that performance testing, biocompatibility, sterilization validation, and in-vivo safety and effectiveness studies were conducted and all tests met pre-determined specifications and acceptance criteria, it does not provide the specific acceptance criteria or the detailed results of these studies. It also explicitly states "N/A" for "Indications for Use" under a section heading, which is likely a formatting error as it also lists indications for use earlier in the document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for any specific test sets (e.g., for mechanical, fluid delivery, or in-vivo studies). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "in-vivo safety and effectiveness studies" without details.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document describes a medical device, and the "ground truth" concept as usually applied to AI algorithms (e.g., expert consensus on images) is not applicable or detailed here. For device performance, the "ground truth" would typically be defined by the physical or biological reality measured during testing against defined specifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned for the Bullfrog Micro-Infusion Device. This type of study is typically associated with diagnostic imaging or AI algorithms, not directly with a physical interventional medical device as described here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The Bullfrog Micro-Infusion Device is a physical interventional medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable in this context.

7. The Type of Ground Truth Used

For a physical device, the "ground truth" is established through engineering specifications, physical measurements, chemical analyses (biocompatibility), and biological outcomes (in-vivo studies, safety/effectiveness). The document generally states that tests met "pre-determined specifications and acceptance criteria," which implies that these specifications serve as the "ground truth" against which performance was measured. No specific mention of expert consensus, pathology, or outcomes data as a distinct ground truth source (like in imaging studies) is given for the device's technical performance.

8. The Sample Size for the Training Set

This information is not applicable. The Bullfrog Micro-Infusion Device is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as it is a physical device and not an AI algorithm.

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