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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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