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The SplitWire Percutaneous Transluminal Angioplasty Scoring device is indicated for the use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The SplitWire Percutaneous Transluminal Angioplasty Scoring Device is designed to facilitate the dilatation of stenoses. The SplitWire device is intended to be used with a percutaneous transluminal angioplasty balloon catheter. The SplitWire device consists of two (2) wires that are joined at the distal end. The larger wire (scoring wire) has a triangular profile near the distal end, that when the balloon is inflated applies pressure to the lesion being treated. The smaller wire (tracking wire) is used to position the PTA balloon catheter in the proper location adjacent to the lesion. There are two (2) radiopaque markers bands on the tracking wire that indicate the location for the PTA balloon catheter placement. The distal section of the SplitWire is designed to be atraumatic with a radiopaque coil for visibility. The distal section is coated with a soft polymer.

I am sorry, but based on the provided document, there is insufficient information to complete your request. The document describes a medical device called the "SplitWire Percutaneous Transluminal Angioplasty Scoring Device" and its 510(k) summary for FDA clearance. It discusses the device's intended use, a comparison to a predicate device, and some non-clinical testing performed.

However, the document does NOT contain details about:

• Specific acceptance criteria for device performance (e.g., quantitative metrics like sensitivity, specificity, accuracy).
• Reported device performance against such criteria.
• The sample size of a test set as this device is not an AI/algorithmic device needing such a set for performance evaluation.
• Data provenance for a test set.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm-only) performance, as this is a physical medical device, not an algorithm.
• The type of ground truth used (pathology, outcomes data, etc.) in the context of an AI device.
• Sample size for a training set (again, this is not an AI/algorithmic device).
• How ground truth for a training set was established.

The "testing" mentioned in the document refers to engineering and biocompatibility bench testing, and animal studies typical for a physical medical device, not the evaluation of an AI algorithm's diagnostic performance.

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