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The proposed Bone Anchor System is intended for use in procedures that require placement of a bone anchor for the purpose of soft tissue reinforcement and support inclusive of, but not limited to, suspending suture/sling for the treatment of urinary stress incontinence attributable to hypermobility and/or intrinsic sphincter deficiency such as: Pubourethral, Urethrovesical, Pubovaginal, and Bladder Neck Support/Stabilization: Urethral and Vaginal Prolapse Repair; and Reconstruction of the Pelvic Floor

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The provided text is related to a 510(k) premarket notification for a medical device called "Bone Anchor Systems" by Boston Scientific Corporation, approved by the FDA in 1997. It describes the device, its classification, and its substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The "Product Testing" section briefly states: "The proposed devices have been tested and compared to the predicate devices. The results indicate that the proposed devices are Substantially Equivalent to the predicate devices in terms of performance characteristics tested." This is a general statement required for 510(k) submissions, which focuses on demonstrating substantial equivalence rather than providing detailed performance metrics against specific acceptance criteria.

Therefore, I cannot fulfill your request for the specific information you asked for, as it is not present in the provided document.

Here's an explicit breakdown of why I cannot answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The document only mentions "performance characteristics" and "substantially equivalent" without quantifiable criteria or results.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. This device is a physical bone anchor system, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be applicable or expected.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided and not applicable for this type of device.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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