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The BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. BiomarC is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML device studies. Instead, it describes a 510(k) submission for a medical device (BiomarC Tissue Marker) based on substantial equivalence to a predicate device.

For medical devices, particularly non-software devices, the "acceptance criteria" are often met through demonstration of substantial equivalence by showing similar technological characteristics and performance to a legally marketed predicate device. The "study" in this context refers to bench testing to demonstrate this substantial equivalence, rather than a clinical trial with specific performance metrics like sensitivity, specificity, etc.

Here's a breakdown of the information based on the provided text, highlighting what is present and what is absent:

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

Note: The actual specific criteria for "safety and effectiveness" during bench testing are not detailed in this summary. For a hardware device like this, these would typically involve biocompatibility, mechanical integrity, visibility under various imaging modalities, etc., all compared to the predicate.

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

• Sample Size: Not specified. "Bench testing" is mentioned, which typically involves laboratory tests on the device itself or test materials, not human or patient data in the sense of a clinical test set.
• Data Provenance: Not applicable for bench testing of a physical device.

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. The "ground truth" for a physical device like this in a 510(k) submission focused on substantial equivalence comes from engineering specifications and performance evaluations against established standards or the predicate device's known performance, not expert consensus on data interpretation.

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

• Not applicable. This concept is relevant for studies involving human interpretation or assessments, such as imaging studies where a consensus ground truth is established.

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 physical tissue marker, not an AI/ML device, and no MRMC study is mentioned.

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

• Not applicable. This is a physical device, not an algorithm. Bench testing evaluates its physical properties and function.

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

• The "ground truth" for this substantial equivalence argument would be the established performance and safety profile of the predicate device, as well as engineering and material specifications relevant to the device's function (e.g., visibility on imaging, biocompatibility). It is established through bench testing.

8. The sample size for the training set

• Not applicable. There is no AI/ML algorithm that would require a training set.

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

• Not applicable. There is no AI/ML algorithm or training set.

Summary of the Study Mentioned:

The "study" described is bench testing. This testing was aimed at demonstrating that the BiomarC Tissue Marker's technological characteristics, safety, and effectiveness are substantially equivalent to a legally marketed predicate device (BiomarC Tissue Marker K001807). The specific details of this bench testing (e.g., methods, parameters, exact outcomes) are not provided in this summary but would have been part of the full 510(k) submission. The FDA reviewed this submission and determined the device to be substantially equivalent, allowing it to proceed to market.

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