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To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.

Bone and Marrow Collection System (BMCS) Instrument Kit

I am sorry, but based on the provided document, the information required to answer your request is not available. The document is a 510(k) clearance letter from the FDA for a "Bone and Marrow Collection System Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain:

1. Acceptance criteria and reported device performance: It only states the device is "substantially equivalent" but does not provide specific performance metrics or criteria.
2. Details of the study: There is no mention of a clinical or performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
3. Training set information: As no study details are provided, there is no information on a training set or its ground truth.

The document is primarily a regulatory approval letter, indicating the device can be legally marketed based on its equivalence to existing devices, rather than a detailed report of a performance study.

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