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The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash PTA Balloon Dilatation Catheter is designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

The Flash PTA Balloon Dilatation Catheter underwent in vitro performance bench testing to confirm its characteristics compared to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

The document does not specify the exact sample size for each performance test. It broadly states that "The Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing." The data provenance is in-vitro bench testing, implying laboratory-controlled conditions. No information on country of origin or retrospective/prospective nature is provided for this specific testing, as it's not clinical data.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not applicable. The study involved in-vitro bench testing and biocompatibility assessments, not a diagnostic task requiring expert interpretation for ground truth establishment.

4. Adjudication Method for Test Set:

Not applicable. This was bench testing against established engineering specifications, not a subjective assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The testing focused on device performance against a predicate and established specifications, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Flash PTA Balloon Dilatation Catheter is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth for the in-vitro performance bench testing was based on established specifications and comparison to the predicate device. For biocompatibility testing, the ground truth was based on the requirements of ISO 10993 and other relevant biological evaluation standards.

8. Sample Size for Training Set:

Not applicable, as this refers to a physical medical device and its manufacturing/performance characteristics, not an AI model that requires a training set.

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

Not applicable for the same reason as above.

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The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash PTA Balloon Dilatation Catheter is designed for dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

This document describes the acceptance criteria and the study conducted for the Flash PTA Balloon Dilatation Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The study described is a series of in-vitro performance bench tests and biocompatibility tests. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size in terms of clinical cases is not applicable here. The samples for these tests would be physical devices or materials, not patient data.

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

Not applicable. The "ground truth" for the in-vitro and biocompatibility tests would be established through predefined scientific and engineering specifications, and validated laboratory methodologies, rather than human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance criteria are based on pre-defined specifications and validated laboratory testing, not human-reviewed clinical cases that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory (in-vitro) and biocompatibility testing, not clinical studies involving human readers or patient cases.

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

Not applicable. This device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established Scientific and Engineering Specifications: For the in-vitro performance bench testing, the device's performance characteristics (e.g., burst pressure, inflation/deflation time, fatigue) must meet predetermined quantitative and qualitative standards.
• Regulatory Standards and Guidelines: For biocompatibility, the ground truth is defined by compliance with international standards such as ISO-10993 and FDA guidelines (e.g., Blue Book Memorandum May 1, 1995) which specify acceptable biological responses to the device materials.

8. The Sample Size for the Training Set

Not applicable. This 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

Not applicable, as no training set was used.

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