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The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral condyle) and cancellous fragments (talus).

The Chondral Dart is molded from Poly(L-lactide), has a diameter of 1.3 mm, and is supplied in a length of 18 mm. The device is barbed to facilitate fixation in bone.

This document, a 510(k) Summary for the Arthrex Chondral Dart, does not contain information on acceptance criteria or a study proving that the device meets those criteria.

The 510(k) Summary focuses on demonstrating substantial equivalence to predicate devices already on the market. It compares the material, size, and insertion method of the Arthrex Chondral Dart to several existing absorbable fixation pins.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory submission seeking clearance based on similarity to existing devices, rather than a clinical or performance study report.

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