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Retrograde suture through soft tissue

The suture retrograder is used to retrograde (pass) suture through soft tissue.

The provided text contains information about a 510(k) premarket notification for the MITEK Suture Retrograder, submitted in 1997. It describes the device, its intended use, and a comparison to predicate devices, but does not include any information about acceptance criteria, clinical studies, or performance metrics from such studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states: "Bench tests were done to demonstrate performance equivalence to predicate devices on the market." This is a very general statement and does not provide the specific details you've requested about acceptance criteria or study methodologies.

Without more detailed information from the submission regarding the bench tests, their specific protocols, and the criteria used to demonstrate equivalence, it is impossible to answer your questions.

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