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The DAUM Bone Biopsy Set is intended for the biopsy of bone tissue. The DAUM Bone Biopsy Set is also a low-artifact-instrument designed to be used in the MRI for the above purpose.

The DAUM Bone Biopsy Set consists of a working tube, stylet, power drill drive, manual drill and an ejector drift. The drill is supplied as a disposable unit. All of the other components of the set are supplied as reusable products.

The provided text describes a 510(k) summary for the DAUM Bone Biopsy Set. It focuses on establishing substantial equivalence to a predicate device and notes performance data related to MR Safety. However, it does not contain the detailed clinical study information typically found when a device's diagnostic or therapeutic efficacy is being evaluated against specific acceptance criteria.

Therefore, many of the requested fields cannot be filled from the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

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

• Not available in the provided text. The document only mentions "Performance Data: The DAUM Bone Biopsy Set has been tested for MR Safety in a 0.2T static magnetic field." It does not specify the sample size of any test set (e.g., number of patients, number of devices tested), nor its provenance (e.g., country of origin, retrospective/prospective nature).

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/Not available in the provided text. The testing described relates to MR safety, not a diagnostic or efficacy study requiring expert assessment of ground truth in the usual sense (e.g., disease presence). No experts are mentioned in relation to establishing ground truth for the MR Safety test.

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

• Not applicable/Not available in the provided text. This type of adjudication is typically for diagnostic studies. The MR safety test described would not involve such a method.

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, an MRMC comparative effectiveness study was not done. This device is a biopsy set, 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 physical medical device (bone biopsy set), not an algorithm.

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

• For the MR Safety testing, the ground truth would have been established by engineering standards and measurement criteria for magnetic field interactions, heating, and artifact generation, not clinical outcomes or expert consensus on diagnosis. The method for determining "acceptable for patient use" in an MR environment would be based on established safety limits and methods for testing metallic implants/devices in MRI.

8. The sample size for the training set

• Not applicable/Not available in the provided text. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As above, no training set for an AI/ML device.

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