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The DARCO Locking Bone Plate System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.

The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, lengths, number of plate holes and through different grades or bridge widths.

The provided text is related to a 510(k) submission for the DARCO Locking Bone Plate System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through performance studies.

Therefore, the document explicitly states:

"Performance Data: No clinical or non-clinical tests were used in the claim of substantial equivalence."

Based on this statement, the device's acceptance criteria and studies demonstrating its performance as requested in the prompt are not applicable to this 510(k) submission.

To directly answer your questions based only on the provided information:

1. A table of acceptance criteria and the reported device performance:

   • No acceptance criteria or reported device performance from studies are provided, as no performance tests were conducted for substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable; no test set or performance data was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable; no ground truth for a test set was established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable; no test set was used.

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:

   • No MRMC comparative effectiveness study was done. This device is a bone plate system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable; this is a medical device (bone plate system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable; no ground truth was established for performance testing.

8. The sample size for the training set:

   • Not applicable; no training set was used.

9. How the ground truth for the training set was established:

   • Not applicable; no training set was used.

The focus of this 510(k) summary is to demonstrate that the DARCO Locking Bone Plate System is substantially equivalent to a legally marketed predicate device (Normed Titanium Osteotomy Plating System K022325) based on its technological characteristics and intended use, without requiring new performance data.

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