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The Powerflex™ Pro PTA catheter is intended to dilate stenoses in illiac, femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-difatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is a catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035″ guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that this document is a 510(k) summary for a medical device (a catheter) and not for a software or AI/ML device. Therefore, many of the requested fields related to software performance evaluation (like multi-reader studies, standalone algorithm performance, number of experts for ground truth, etc.) are not applicable in this context.

The document describes the process for obtaining 510(k) clearance for additional sizes of an existing Percutaneous Transluminal Angioplasty (PTA) catheter, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists performance tests conducted, implying these tests have associated acceptance criteria that the device met. However, the specific numerical acceptance criteria for each test are not provided in this summary. It only states that the tests were "completed" and "no new safety or performance issues were raised."

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

• Sample Size: The document does not specify the sample size for each performance test. It generically states that "non-clinical design verification" and "in-vitro performance tests" were completed.
• Data Provenance: The data is from "non-clinical design verification" and "in-vitro performance tests" conducted by the manufacturer (Cordis Corporation). This is retrospective, in-house testing. Country of origin is not explicitly stated for the testing, but the company is based in Bridgewater, NJ, USA.

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

Not Applicable. This is a medical device (catheter) 510(k) summary, not a software or AI/ML device. Ground truth, in this context, would be established by engineering specifications and objective measurements, not by expert interpretation for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not Applicable. As above, this pertains to physical device performance and conformity to engineering specifications, not subjective interpretation requiring expert adjudication.

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:

Not Applicable. This is not a software or AI/ML device that assists human readers.

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

Not Applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance tests would be based on:

• Engineering Specifications: Predetermined design parameters and performance thresholds (e.g., specific balloon diameters, burst pressures, tensile strengths).
• Standardized Test Methods: Adherence to established test protocols (likely internal company protocols and potentially relevant ISO standards, as Bio-compatibility refers to ISO 10993-1:2009).
• Objective Measurements: Direct physical measurements and observations of the device components and entire system during in-vitro testing.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical medical device, not a software or AI/ML model that requires a training set.

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

Not Applicable. (See point 8).

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The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is intended to dilate stenoses in 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 device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.

The provided text describes the Cordis Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter. It outlines the device description, indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" with specific quantitative thresholds. Instead, it states that the conducted in-vitro performance tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." The performance is demonstrated by the completion of these tests aligning with engineering standards and existing predicate devices.

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

• Sample Size: The document does not specify the exact sample sizes used for each of the in-vitro performance tests. It merely lists the tests that were completed.
• Data Provenance: The studies were "non-clinical design verification and validation tests and analyses," meaning they were laboratory/bench tests. The origin of the data is therefore laboratory-based, and not patient-specific (i.e., not a clinical study involving human subjects). It also mentions "post-market surveillance data analyses of the predicate devices," which would be retrospective data from existing devices.

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

Not applicable. This device's safety and effectiveness were demonstrated through non-clinical, bench testing and comparison to predicate devices, not through a diagnostic accuracy study requiring expert consensus on a test set to establish "ground truth."

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring human adjudication in the context of diagnostic accuracy. The testing was laboratory-based.

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

Not applicable. This is a medical device (catheter), not an AI diagnostic software.

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

Not applicable. This is a medical device (catheter), not an AI algorithm. The performance described is "standalone" in the sense that the device itself was tested in a lab setting, but not in the context of an AI algorithm's performance.

7. The Type of Ground Truth Used

For the in-vitro performance tests, the "ground truth" would be established by:

• Engineering specifications and design requirements.
• Industry standards (e.g., ISO for biocompatibility).
• Performance characteristics of the legally marketed predicate devices.
• Accepted scientific and engineering principles for material properties and mechanical function.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.

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

Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.

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