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The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The subject device is a totally disposable tape mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. It consists of a polypropylene tape with integral fixation zones on either side of a central mesh sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.

The provided text is a 510(k) summary for the "Modified Minitape* Urethral Sling" and primarily discusses regulatory information, device description, and indications for use. It briefly mentions "in-vitro and in-vivo testing" that "demonstrate the ability of the device to adequately restrain urethral tissue," but it does not contain the detailed information required to answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert qualifications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The document states that testing was performed, but it does not describe the specific study (or studies), their methodologies, or their results in a way that allows for the extraction of the requested information.

Missing Information:

• Acceptance Criteria Table: The document does not specify any quantitative or qualitative acceptance criteria for device performance.
• Sample sizes (test set), data provenance: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth: Not mentioned, although for a physical device like a sling, "ground truth" would likely relate to clinical outcomes, physiological measurements, or imaging post-implantation, none of which are detailed here.
• Sample size for training set: Not applicable as this is a physical medical device, not an AI algorithm.
• How ground truth for training set was established: Not applicable as this is a physical medical device, not an AI algorithm.

The core of the provided document is the 510(k) regulatory submission, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed scientific study report.

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