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The proposed device is intended for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed device is a sterile, single use device, consisting of a synthetic mesh assembly and needle holder. The mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the currently legally marketed Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

This document is a 510(k) summary for a surgical mesh device, the "Modified Pinnacle Pelvic Floor Repair Kit - Apical." It largely focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and performance characteristics.

The provided text does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for proving the device meets performance criteria. The document explicitly states that "the proposed device is as safe, as effective, and performs as well as the predicate device" based on a direct comparison of key characteristics, but it does not present any specific data or studies to support this claim in the context of device performance metrics against acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I fill in the requested table and sample size details, as this information is absent from the provided text.

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