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The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

The PTA 14 Balloon Dilatation Catheter OTW is a 0.014" Over-The-Wire (OTW) PTA Balloon Dilatation Catheter with a semi-compliant inflatable balloon mounted on the distal end of the catheter. It is designed for carrying out percutaneous transluminal angioplasty (PTA) in the peripheral vessels. The balloon catheter has a coaxial shaft design. The outer lumen is used for balloon inflation and the inner lumen (guide wire lumen) permits the use of a guide wire with a maximum outer diameter of 0.014 inch. The proximal segment of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock for the guide wire lumen. The PTA 14 Balloon Dilatation Catheter is compatible with a 4 Fr. introducer sheath. The device is supplied sterile and is intended for single use.

The document is a 510(k) premarket notification for the "PTA 14 Balloon Dilatation Catheter OTW". This type of submission is for medical devices, and focuses on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy or diagnostic accuracy for an AI/ML product. As such, the information typically requested for AI/ML device evaluations (e.g., sample size for test/training sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance) is not applicable or provided in this document.

The document details performance and safety testing directly related to the physical characteristics and interaction of the catheter with the human body.

Here's the information parsed from the document based on the provided categories, with a clear indication that many categories relevant to AI/ML are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Testing Summary" (Section 7) and a "Bench Testing Table" (Table 7.1.1) along with a "Summary of Biocompatibility Testing" (Table 7.2.1). For each test, the acceptance criteria are implied by the "Pass" result and the "Applicable Standard or Internal Test Method" column. The reported device performance is that all tests "Passed" the predetermined acceptance criteria. Specific quantitative acceptance criteria are not detailed in this summary, but are referred to by the internal test methods or referenced standards.

Biocompatibility Tests (All Met Predetermined Acceptance Criteria)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is Not Applicable as this document describes performance testing for a physical medical device (catheter), not an AI/ML software. The "test set" refers to physical samples of the device itself (both unaged and aged), which were subjected to various bench and biocompatibility tests. No human patient data or imaging data is involved.

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. Ground truth, in the context of AI/ML, refers to expert-labeled data. For a physical device, performance is evaluated against engineering specifications and established standards, not expert consensus on data interpretation.

4. Adjudication method for the test set

This information is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies among expert readers when establishing ground truth for data interpretation. This is not relevant for the bench and biocompatibility testing of a physical medical device.

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 information is Not Applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic accuracy of a reader (human or AI) on multiple cases, often comparing different reading paradigms (e.g., with or without AI assistance). This document is for a physical medical device and does not involve AI or human readers for diagnostic interpretation.

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

This information is Not Applicable. This concept applies to AI/ML algorithms where performance is evaluated without human intervention. The device in question is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is Not Applicable in the AI/ML sense. For this device, the "ground truth" aligns with the acceptance criteria derived from engineering specifications and recognized international standards (e.g., ISO, ASTM, FDA Guidance). Device performance is measured directly against these defined physical, mechanical, and biological benchmarks.

8. The sample size for the training set

This information is Not Applicable. "Training set" refers to data used to train an AI/ML model. This device is a physical product and does not involve AI/ML.

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

This information is Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.

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