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The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

The proposed Flash PTA Balloon Dilatation Catheter is designed for dilation of aorto-ostial lesions of peripheral vessels in the arterial system. The Flash PTA Balloon Dilatation Catheter is a .014" guidewirecompatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon that enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Flash PTA Balloon Dilatation Catheter, structured according to your request:

Acceptance Criteria and Study for Flash PTA Balloon Dilatation Catheter

The provided document describes the Flash PTA Balloon Dilatation Catheter, a device for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The information details the device's characteristics, intended use, and performance data used to establish substantial equivalence to a predicate device (Sterling PTA Balloon Dilation Catheter).

However, it's crucial to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical trial with pre-defined acceptance criteria for a novel device. Therefore, some of the requested information, particularly regarding specific performance metrics with numerical acceptance criteria and a detailed clinical study with human readers, is not explicitly present in this type of submission.

The "acceptance criteria" discussed in the document refer to the successful completion of various biocompatibility tests and in-vitro bench tests to ensure the materials and design meet established specifications and perform comparably to the predicate device. The conclusion states: "The Flash PTA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs." This implies that the device successfully passed these tests, but specific numerical thresholds are not provided in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria for performance metrics (e.g., target accuracy, sensitivity, specificity) for a diagnostic or AI-driven device are not applicable here. Instead, the document lists various tests that were successfully completed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.

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

• Test Set Sample Size:
  • In-vitro Bench Testing: Not specified for each individual test. The document states "The proposed Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing," implying multiple units were tested for each characteristic.
  • In-vivo Testing: "a swine model" was used. The specific number of animals is not provided.
• Data Provenance:
  • Biocompatibility & In-vitro Bench Testing: Likely performed in a controlled laboratory setting (manufacturer's or contract lab). No specific country of origin is mentioned.
  • In-vivo Testing: Animal model (swine). No specific country of origin is mentioned.
• Retrospective or Prospective: These tests are inherently prospective as they are specifically conducted to evaluate the device.

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

• This device is not an AI/diagnostic device that requires expert-established ground truth in the same way. The "ground truth" for its performance is derived from objective physical measurements, chemical analyses, and biological responses (e.g., burst pressure, material reactions, animal physiological responses).
• Expert involvement would primarily be in designing and interpreting the technical and biological tests, likely by engineers, material scientists, and toxicologists, rather than clinicians establishing a diagnostic ground truth. The document does not specify the number or qualifications of these technical experts.

4. Adjudication Method for the Test Set

• Not applicable in the context of this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or diagnostic interpretations, not for bench or animal testing. The "adjudication" here would be the successful completion of the pre-defined test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

• No. This is a balloon dilatation catheter, a physical medical device for interventional procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant and were not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

• As mentioned in point 3, the "ground truth" for this device's performance is based on:
  • Objective Technical Measurements: Such as precise measurements of catheter shaft diameter, balloon dimensions, inflation/deflation times, pressure endurance (rated burst pressure), and material strengths (bond, tip pull, torque).
  • Standardized Biological Assays: Following ISO 10993 for biocompatibility, detecting specific biological reactions (hemolysis, complement activation, pyrogenicity, sensitization).
  • In-vivo Physiological Responses: Observing the physical effects and downstream/cognitive impacts in a live animal model during and after a simulated angioplasty procedure.
  • The term "ground truth" as typically used for AI/diagnostic devices (e.g., pathology, clinical outcomes) doesn't directly apply here.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not an AI or machine learning model that requires a training set. The "training" for this device involved design and engineering development, not data-driven algorithm training.

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

• Not applicable. As explained above, there is no "training set" in the context of an AI/ML model for this device.

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