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The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only.

The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects which can occur as a result of trauma or in skeletal defects created surgically.

The Orthos-BMA™ kit contains the apparatus required for the collection of bone marrow using a minimally invasive aspiration technique.

The Orthos-BMA™ kit provides the surgeon with a convenient method of harvesting autologus bone marrow and combining it with their choice of osteoconductive material such as autogenous bone or a bone void filler such as ßGran synthetic osteoconductive scaffold.

The Orthos-BMA kit is supplied sterile for single patient use.

The provided text is a 510(k) summary for the Orthos-BMA Kit and a letter from the FDA regarding its clearance. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, the document does not contain any information about acceptance criteria, detailed performance studies, sample sizes for testing or training, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table or answer most of the questions using the provided text.

Here's what can be extracted from the document:

• Device Name: Orthos-BMA™ Kit
• Intended Use: To harvest bone marrow and combine it with an osteoconductive material for the treatment of osseous defects resulting from trauma or surgical creation.

The document emphasizes "substantial equivalence" to predicate devices, which means the FDA determined it is as safe and effective as a legally marketed device. This type of clearance generally does not require the submission of new clinical studies proving specific performance metrics against pre-defined acceptance criteria in the same way a PMA would.

Missing Information:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample size for the test set and data provenance: Not available.
3. Number of experts and their qualifications for ground truth: Not applicable/available as no specific performance study is detailed with an independent ground truth.
4. Adjudication method for the test set: Not applicable/available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and unlikely for this type of device clearance.
6. Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable/available.
8. Sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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