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The Scoreflex PTA Scoring Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of instent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

The Scoreflex PTA Scoring Balloon Catheter is designed for easy guidewire exchange and available with balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, and 6.0mm, balloon lengths of 15, 20 and 40mm and a catheter working length of 40, 90, or 150cm. There are two catheter designs within the Scoreflex family: the no-coil design has a smaller shaft profile than the corresponding coil design catheter of the same balloon configuration which will allow for access to more distal lesions while the coil design minimizes balloon curvature during inflation. The balloon is made of a semi-complaint material with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon jacketed stainless steel hypotube and the scoring wire is laser welded to the distal end of the hypotube. The proximal shaft joins with a smooth transition to the distal shaft (composed of an outer nylon tube with the balloon/tip tube and scoring wire welded at the distal tip). The cutting section of the scoring wire is outside of the balloon. Two radiopaque platinum/iridium marker bands are located on the scoring wire and aligned with the balloon shoulders to ensure accurate positioning of the balloon. The tip lumen is compatible with either a standard 0.014 inch (0.36mm) or 0.018 inch (0.46mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. The catheter is lubricated with hydrophilic coating on the tip and the distal outer body surface; the tip lumen and the balloon are lubricated with silicone coating.

The provided text is a 510(k) Summary for a medical device (Scoreflex PTA Scoring Balloon Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific clinical acceptance criteria for an AI/ML product.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance in the context of an AI/ML device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML system.
• Sample size details for a test set, data provenance, number of experts, adjudication methods, or ground truth establishment for an AI/ML system's evaluation.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm-only performance.
• Details about training set sample size or how ground truth was established for a training set in an AI/ML context.

The "Performance Data" section lists various engineering and biocompatibility tests performed on the physical catheter device, such as "Balloon Rated Burst Pressure," "Shaft Burst," "Balloon Fatigue," and "Biocompatibility." These tests are typical for physical medical devices to ensure their safety and mechanical integrity, but are not related to the performance evaluation of an AI/ML algorithm.

The conclusion states that "The Scoreflex PTA Scoring Balloon Catheter test results met all acceptance criteria and were similar to the predicate and reference devices." However, these "acceptance criteria" refer to the engineering and biocompatibility specifications for the physical catheter, not the performance metrics of an AI/ML system.

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The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion. The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. The Sapphire® II PRO balloon dilatation catheter is also indicated for: percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO balloon dilatation catheter is a rapid exchange balloon catheter with a working length of 140cm design for both coronary and peripheral indications. This catheter was previously cleared for coronary use (K173680, K163114) and this submission is intended to support the peripheral use of this balloon catheter. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-4.0mm and lengths from 5-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for the Ø1.0-1.5mm configurations). The catheter is compatible with 4F or larger guiding sheaths or 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a guiding sheath or guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sapphire II PRO Balloon Dilatation Catheter, focusing on the peripheral use indication:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the device "met all acceptance criteria" and "were similar to the reference devices" for the performed tests.

The performance tests conducted include:

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

The document does not provide specific sample sizes for any of the tests. It refers to testing being "leveraged from the reference device (K173680, K163114)" for many criteria, and "additional testing was performed" for others.

There is no information on the country of origin of the data, and the studies are retrospective in the sense that existing data from previous clearances (K173680, K163114) were used, supplemented by new (implicitly prospective) tests for the peripheral use indication.

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

This document describes a medical device clearance for a balloon catheter, not an AI/software device. Therefore, the concept of "experts" establishing ground truth in the context of clinical imagery or diagnostic data is not applicable here. The ground truth for device performance is established through engineering and performance testing against predetermined specifications.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device performance testing. Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases, often in AI development contexts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI system being evaluated for diagnostic or interpretive tasks by 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 or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established performance standards for balloon dilatation catheters. These standards are likely derived from industry best practices, regulatory guidance, and clinical requirements for the safe and effective operation of such devices. For example, balloon burst pressure needs to meet a certain PSI, and shaft flexibility needs to fall within a defined range.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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