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The Ebony HP PTA OTW 0.035" Catheter is indicated for;

· Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

· Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Ebony HP PTA OTW 0.035" Catheter is a standard Over The Wire (OTW) PTA catheter with a non-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end to facilitate advancement of the catheter through the stenosis, and a luer lock fitting (Y hub) at the proximal end allowing the connection with an inflation device. The catheter is a two lumen catheter; one lumen is used for inflation of the balloon and accessed via the lateral port of the Y hub. The second lumen, starting at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The maximum recommended guide wire diameter is 0.035". The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. The working pressure range for the balloon is between the nominal pressure (NP) and the rated burst pressure (RBP). A hydrophilic coating solution is applied on the distal section of the shaft and on the balloon to improve the pushability of the catheter by reduction of the friction coefficient of the outer body.

This document describes the premarket notification (510(k)) for the Ebony HP PTA OTW 0.035" Catheter. The information provided outlines the device's characteristics, indications for use, and the performance data that supports its substantial equivalence to predicate devices. However, the document does not contain details regarding a study for an AI/ML powered medical device, particularly with the specific criteria asked for in your prompt (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment).

Therefore, I cannot extract the information required to populate the fields related to an AI/ML study from the given text. The document focuses on the non-clinical performance testing of a physical medical device (a catheter) and its biocompatibility, mechanical properties, and compliance with standards.

To directly answer your request based on the provided text, the device in question is a physical medical device, not an AI/ML powered one. Thus, the concepts of acceptance criteria for AI performance, training/test sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The Ebony® PTA .035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal & renal arteries. The Ebony® PTA . 035'' OTW Peripheral Dilatation Catheter is not for use in the coronary arteries and neuro-vasculature.

The Ebony® PTA 0.035 Peripheral Dilatation Catheter is a standard Over The Wire (OTW) PTA catheter with a semi-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature. The modified Ebony® PTA 0.035 Peripheral Dilatation Catheter line extension adds 3.0 mm and 4.0 mm diameter balloon and additional balloon lengths to the currently available sizes.

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

It's important to note that this document is a 510(k) premarket notification summary for a medical device. For such devices, the "study" demonstrating that the device meets acceptance criteria often refers to non-clinical bench testing to show substantial equivalence to a predicate device, rather than a clinical trial with human participants if the changes are minor. This is the case here.

Acceptance Criteria and Device Performance for Ebony® PTA 0.035 Peripheral Dilatation Catheter (K143036)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each non-clinical bench test. It generally states that the "new balloon sizes met all of the verification/validation acceptance criteria."
• Data Provenance: The data provenance is from non-clinical bench testing. It's not human data and therefore does not have a country of origin in the typical sense; these tests are performed in a laboratory setting. These were retrospective in relation to the original K103354 device, as the tests were performed on the modified device to show equivalence to the previously cleared predicate.

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

• N/A. For non-clinical bench testing (like mechanical and material properties of a catheter), "expert ground truth" in the way it's described for image analysis or clinical outcomes is not applicable. The "ground truth" for these tests is based on established engineering principles, material science, and regulatory standards for device performance, which are evaluated by qualified engineers and scientists.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in clinical or image-based studies. For bench testing, the results are typically quantitative measurements against predefined specifications; there's no "adjudication" of expert opinions involved.

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

• No. An MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. This device is a physical medical device (a catheter) and not an AI-powered diagnostic tool, so such a study would not be applicable.

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

• No. This question is typically relevant for AI algorithms. Since this is a physical medical device (catheter), the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is based on regulatory standards and established engineering specifications for the physical and functional performance of a PTA catheter. This includes parameters like balloon burst pressure, fatigue, material biocompatibility, and physical dimensions, all of which are defined and verified through objective measurements and tests. The predicate device (K103354) served as the benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

• N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are likely refined through engineering development and quality control, but this isn't analogous to an AI training set.

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

• N/A. As there is no "training set" in the AI sense, this question is not applicable. The performance characteristics and specifications for the device are derived from engineering design, material properties, and regulatory requirements for safe and effective medical devices.

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