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For harvesting bone marrow.

The MarrowMiner is a device intended for harvesting bone marrow. The StemCor MarrowMiner bone marrow collection system is comprised of four components; a MarrowMiner battery powered handle, an aspiration chamber, a flexible aspiration shaft, and an access guide. The tip of the flexible aspiration shaft rotates and aspirates bone marrow. The device has been shown in animal studies to obtain adequate bone marrow samples without compromising the iliac crest integrity.

The provided document is a 510(k) Premarket Notification summary for the StemCor Systems, Inc. MarrowMiner. It describes the device, its intended use, and indicates its substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, study data, or performance metrics.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone performance (algorithm only) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on regulatory approval based on substantial equivalence to predicate devices, not on detailed performance study results against specific acceptance criteria. It mentions "The device has been shown in animal studies to obtain adequate bone marrow samples without compromising the iliac crest integrity," but no specific data, acceptance criteria, or study details are provided.

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The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.

The device is a hand-held battery powered device that penetrates the bone and allows aspiration through a hole in the bit for bone marrow harvest. The device is made from medical grade components and sold as a disposable procedure kit and a reusable motor unit.

This document is a 510(k) summary for the BioAccess Marrow Harvest System, submitted in 1997. It describes a medical device and its substantial equivalence to previously marketed devices. The document does not contain information about acceptance criteria or a study proving a device meets acceptance criteria, as it pertains to a physical medical device (a marrow harvest system) and not an AI/ML powered device.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically associated with AI/ML device submissions, which are much more recent than a 1997 510(k) for a physical surgical instrument.

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