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The BioZorb SP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

The BioZorb SP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb SP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb SP Marker is provided sterile for single use and is implantable.

The provided text is a 510(k) summary for the BioZorb SP Marker and a letter from the FDA determining substantial equivalence. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop performance study.

Here's what can be extracted and what is missing:

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

The document states:

• Acceptance Criteria (Implied): "The BioZorb SP Marker met all specified input criteria and did not raise new safety or performance questions." (This is a general statement, not specific criteria points).
• Reported Device Performance: "Performance data with regards to imaging assessment and MR compatibility are provided in support of the substantial equivalence."

A specific table cannot be created from the given text as the detailed acceptance criteria and performance metrics are not listed. The document broadly indicates that the device met its intended performance based on imaging assessment and MR compatibility, which are considered sufficient to establish substantial equivalence to predicate devices.

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

This information is not provided in the document. The text mentions "performance data with regards to imaging assessment and MR compatibility," but gives no details about the studies' design, sample sizes, or data provenance.

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)

This information is not provided in the document. The document refers to "imaging assessment" but does not detail how ground truth was established or who assessed it.

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

This information is not provided in the 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

An MRMC study, particularly one involving AI, is not mentioned or implied in this document. The device is an implantable radiographic marker, not an AI diagnostic algorithm. Therefore, "human readers improve with AI vs without AI assistance" is not applicable in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical implantable marker, not an AI algorithm.

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

This information is not explicitly stated. Given the device's nature (radiographic marker), the "imaging assessment" likely relied on visual confirmation by experts, but the exact method (e.g., expert consensus on image quality, visibility, or MR safety) is not detailed.

8. The sample size for the training set

This information is not provided and is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

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

This information is not provided and is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

In summary, the provided FDA document is for an implantable radiographic marker and focuses on demonstrating substantial equivalence to predicate devices based on its physical characteristics, indications for use, and general performance (imaging assessment and MR compatibility). It does not contain the detailed clinical study data, AI performance metrics, or reader study information typically associated with evaluating AI-powered diagnostic devices per your request.

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