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The Pinnacle™ Pelvic Floor Repair Kits are indicated 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. The proposed mesh will be offered in three mesh models: Total, Anterior/Apical and Posterior designed for performing total vaginal repair, anterior vaginal defects and posterior and/or apical vaginal vault defects respectively.

This document is a 510(k) summary for the Pinnacle™ Pelvic Floor Repair Mesh, a surgical mesh device. The provided text is a regulatory submission to the FDA and does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it contain details about performance metrics, sample sizes, expert ground truth, or adjudication methods.

The content is primarily focused on:

• Sponsor and contact information.
• Device name, common name, classification, and regulation number.
• Identification of a predicate device (Polyform Synthetic Mesh).
• A general description of the device components and its intended models (Total, Anterior/Apical, Posterior).
• An official FDA letter confirming substantial equivalence to the predicate device.
• The "Indications for Use Statement" specifying the device's intended purpose for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval notice, not a clinical study report or a statistical analysis of device performance against pre-defined acceptance criteria.

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