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The Surgical Dynamics Ogden Suture Anchor with Suture is indicated for the reapproximation of soft tissuue.

The currently marketed Surgical Dynamics Ogden Suture Anchor with Suture is a nonabsorbable repair device used to attach soft tissue to bone using sutures. The device is a self tapping, Ti-6A1-4V threaded implant with a central cannulation to accommodate one or two sutures. The sterile package includes a Suture Anchor, Suture Passer, and Surgidac suture.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Surgical Dynamics Ogden Suture Anchor with Suture). It focuses on the device description, indications for use, and a claim of substantial equivalence to a legally marketed predicate device, as required for FDA clearance.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Information about standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary document. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, often through bench testing and comparison of technical characteristics, rather than extensive clinical efficacy studies akin to those required for new drug applications or PMA devices.

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