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The Resorbable LactoSorb-L® ACL Crosspin is indicated for ACL reconstruction.

The Resorbable LactoSorb-L® ACL Crosspin is comprised of a PI LA:PGA copolymer. The threadless, push-in device is used for femoral fixation of a soft tissue graft. The Resorbable LactoSorb-L® ACL Crosspin includes a suture eyelet at the tip. This eyelet allows the device to be used with a technique similar to that utilized by cannulated devices, however, the crosspin is not cannulated.

The provided document does not describe any clinical studies or acceptance criteria in the context of device performance in humans.

Instead, the document is a 510(k) premarket notification for the Resorbable LactoSorb-L® ACL Crosspin, where the manufacturer is seeking to establish substantial equivalence to previously marketed devices.

Here's what the document does state regarding testing:

• Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence."
• Clinical Testing: "Clinical testing was not used to establish substantial equivalence."

This means the device's safety and effectiveness were demonstrated through benchtop mechanical tests, comparing its physical properties to predicate devices. There was no human-subject study reported that would involve acceptance criteria for clinical performance or human reader analysis.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance (in human studies).
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study and effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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