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The Amphirion™ Plus PTA Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Amphirion Plus PTA Catheter (also referred to as Amphirion Plus) is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, coaxial body catheter shaft, and a distal dilatation balloon. The Amphirion Plus device consists of a coaxial lumen. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the balloon. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The Amphirion Plus PTA Catheter is compatible with guidewires with a maximum diameter of 0.014" and with 4F introducer sheaths. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 100cm and 150cm.

This submission describes the Amphirion™ Plus PTA Catheter, an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter. The device is intended to dilate stenosis in various arteries and treat obstructive lesions in dialysis fistulae. The 510(k) summary indicates that the device is substantially equivalent to predicate devices, with modifications primarily in balloon length, and no new safety or effectiveness issues were observed during testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that a battery of bench and biocompatibility tests were performed, and all pre-determined acceptance criteria were met. However, the specific quantitative acceptance criteria values for each test are not detailed in the provided text. The output primarily indicates "All of the pre-determined acceptance criteria were met and results passed." for each category.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each bench or biocompatibility test. It mentions that "The Amphirion Plus PTA Catheter was thoroughly tested on the bench" and "Biocompatibility testing was conducted on the finished Amphirion Plus PTA Catheter." These are general statements without specific numbers.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be laboratory-based (bench and biocompatibility testing) and thus would be considered pre-clinical rather than involving human subjects. Therefore, the retrospective or prospective nature of clinical data is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The tests performed are engineering and biological evaluations, not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests would be the established scientific and engineering standards and methods.

4. Adjudication method for the test set

This information is not applicable. This is not a study involving multiple human readers or interpretations needing adjudication. The tests have objective criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a PTA catheter, a physical medical device, not an AI or imaging diagnostic tool.

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

This is not applicable as the device is a physical medical device. Performance is assessed through bench and biocompatibility testing, not an algorithm.

7. The type of ground truth used

The "ground truth" for the tests performed can be considered:

• Bench Testing: Engineering specifications, material properties, and performance standards as defined by relevant FDA guidance documents, ISO, and ASTM standards.
• Biocompatibility Testing: Established biological safety limits and responses as defined by ANSI/AAMI/ISO10993-1, FDA 21 CFR Part 58 (GLP), and FDA guidance for PTCA catheters.

8. The sample size for the training set

This is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable.

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