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The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue.

The Prostate Tissue Marker consists of a pure gold marker placed inside a 17 Ga disposable beveled needle applicator. Also contained in the needle are 2 resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets and a polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed in approximately 12 weeks.

This is an FDA 510(k) premarket notification for the SenoRx Prostate Tissue Marker. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with acceptance criteria.

Therefore, many of the requested categories for a comprehensive performance study (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included or required in a 510(k) summary focused on substantial equivalence.

Based on the provided document, here's the information that can be extracted or deduced:

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The submission focuses on demonstrating that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

The "performance" described is largely based on the equivalence to predicate devices:

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

Not provided. The 510(k) summary does not detail a clinical test set or study with specific sample sizes. Substantial equivalence is demonstrated through comparison to predicates, material characterization, and potentially bench testing, not typically through a clinical performance study with a 'test set' as defined for AI/software.

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. No ground truth establishment for a clinical test set is described.

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

Not applicable. No clinical test set and related adjudication method are described.

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

Not applicable. This is a tissue marker device, not an AI or software device.

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

Not applicable. This is a tissue marker device, not an AI or software algorithm.

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

Not applicable. No ground truth is described in the context of a performance study in this 510(k) summary. The "ground truth" for the device's function is its physical presence and radiopacity as observed in imaging, and its biocompatibility, which would have been assessed through preclinical testing (not detailed in this summary).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI algorithm.

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