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To aseptically and efficiently collect osseous and marrow tissue during the drilling of skeletal structures. For the collection of autogenous bone and marrow tissues. For use with the BMCS Instrument Kit to facilitate implantation of autogenous bone and marrow tissue.

Bone and Marrow Collection System (BMCS)

This document is a 510(k) premarket notification letter from the FDA regarding a "Bone & Marrow Collection System." It indicates that the device has been found substantially equivalent to predicate devices marketed prior to May 28, 1976. This specific type of document does not contain information about acceptance criteria or specific studies demonstrating performance.

The FDA 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not necessarily a demonstration of clinical efficacy or performance against specific, pre-defined acceptance criteria through a study as would be detailed for a novel or high-risk device. The letter simply states the device is "substantially equivalent" for its stated indications for use (found on page 2 of the document).

Therefore, based solely on the provided text, I cannot provide the information requested:

1. A table of acceptance criteria and the reported device performance: Not present in this document.
2. Sample size used for the test set and the data provenance: Not present in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in this document.
4. Adjudication method for the test set: Not present in this document.
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: Not present in this document. This is also highly unlikely for a bone and marrow collection system, which is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present in this document. Again, this is not relevant for this type of device.
7. The type of ground truth used: Not present in this document.
8. The sample size for the training set: Not present in this document.
9. How the ground truth for the training set was established: Not present in this document.

For a 510(k) submission, the "study" that proves the device meets acceptance criteria is often a battery of non-clinical tests (e.g., biocompatibility, sterility, mechanical testing, performance testing compared to the predicate device) rather than clinical studies with human participants and ground truth establishment in the manner described in your prompt, especially for Class I devices like this one. The acceptance criteria would be defined by the manufacturer and often relate to these non-clinical performance aspects and comparison to the predicate. This information would typically be in the 510(k) submission itself, not the FDA's decision letter.

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