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The AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant for the treatment of male stress urinary incontinence (SUI).

The AMS Male Transobturator Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement using a transobturator approach. The slings are made from polymeric mesh and have resorbable sutures.

The provided text is a 510(k) summary for the AMS Male Transobturator Sling System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than reporting on a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations.

Therefore, I cannot extract the requested information because the document does not contain:

• A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm.
• Information about sample sizes for test sets, data provenance, or ground truth establishment relevant to an AI/ML study.
• Details on expert involvement, adjudication methods, or MRMC studies for AI/ML performance.
• Separate standalone performance data for an algorithm.
• Training set information for an AI/ML device.

The study described is focused on demonstrating substantial equivalence of a surgical device and its components to existing, legally marketed predicate devices through:

• Bench testing (previously cleared and new)
• Biocompatibility testing
• Cadaver studies
• Clinical data (likely for predicate devices and potentially limited comparative data for the new device, but not detailed as an AI/ML performance study)
• A literature review

The "Supporting Information" section on page 0 mentions "clinical data," but this is not presented in a format that would allow for the detailed answers requested for an AI/ML device's acceptance criteria and study design.

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