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The proposed Pelvic Floor Repair System is 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 kit, consisting of two synthetic mesh assemblies and a needle holder. Each 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 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 configurations were designed for performing vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs.

The provided text pertains to a 510(k) summary for a medical device called the "Pelvic Floor Repair System" (Tradename: TBD, later identified as Pinnacle Pelvic Repair Kit). A 510(k) submission is a premarket notification demonstrating that a medical device is at least as safe and effective as a legally marketed device (predicate device). This type of submission relies on demonstrating substantial equivalence, not necessarily on new clinical trials or detailed performance study reports with specific acceptance criteria that one would find for a novel device or a Premarket Approval (PMA) application.

Therefore, the document does not contain the acceptance criteria and a study proving the device meets those criteria in the way you've outlined. This is because the 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than fulfilling specific performance metrics from a new, independent study with pre-defined acceptance criteria.

The document indicates that substantial equivalence was demonstrated by comparing key characteristics of the proposed device to predicate devices (K071957 and K081048, both also "Pinnacle Pelvic Floor Repair Kit"). It states: "A direct comparison of key characteristics demonstrates that the proposed mesh is substantially equivalent to the predicate mesh in terms of intended use, technological characteristics, and performance characteristics tested. The proposed device is as safe, as effective, and performs as well as the predicate device."

Without a new performance study being conducted for this specific 510(k) submission, the requested information (acceptance criteria, sample size, ground truth, MRMC study details, etc.) cannot be extracted from this document. The "performance characteristics tested" mentioned likely refer to bench testing or material characterization to ensure similarity to the predicate, rather than a clinical study with human subjects.

Therefore, I cannot populate the table or answer the specific questions because the detailed information about a study proving the device meets acceptance criteria is not present in this 510(k) summary. The summary focuses on showing equivalence to existing devices.

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