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The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with multiple embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

The provided text describes a 510(k) premarket notification for the Serranator® PTA Serration Balloon Catheter. This notification is a "consolidation (i.e., bundling) of previously cleared 510(k) indication statements and labeling." The key takeaway is that the device described in this submission (K220704) is identical to previously cleared devices (K213728 and K203437) in terms of "purpose, design, materials, energy source, function, or any other feature." Therefore, no new performance data or studies were conducted for this specific submission.

The document does not contain any information about acceptance criteria or a new study proving the device meets new acceptance criteria for this K220704 submission. It explicitly states: "No new data are included in this bundled 510(K) application. The Serranator® PTA Serration Balloon Catheters represented in this bundled submission do not differ in purpose, design, materials, energy source, function, or any other feature. Performance data previously provided in K213728 and K203437 demonstrate that the devices function as intended."

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study that proves the device meets them, as no new study was performed for this specific submission to demonstrate compliance with new acceptance criteria. The device's substantial equivalence is based on its identity to previously cleared devices and the previous performance data.

To answer your request, one would need to refer to the original 510(k) submissions (K213728 and K203437) to find the acceptance criteria and study details.

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The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illac, femoral, and poplited arteries for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

The provided text is a 510(k) Premarket Notification for a medical device called the Serranator® PTA Serration Balloon Catheter. It discusses the device's indications for use, description, and comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or the results of a clinical study that proves the device meets these criteria.

The "NON-CLINICAL TESTING/PERFORMANCE DATA" section states that "bench tests were performed" and "In vitro bench testing demonstrated that the subject device performed as intended and similar to the predicate device." This refers to laboratory tests, not human clinical trials. There is no mention of an AI component, human readers, or ground truth establishment relevant to AI performance.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving clinical performance against specific acceptance criteria in a human study.

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