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The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.

The provided document is a 510(k) Summary for the BiomarC Fiducial Marker (K132064). This document primarily establishes substantial equivalence of the device to predicate devices and outlines its indications for use and technological characteristics.

Critically, the provided text DOES NOT contain information regarding a study that proves the device meets specific acceptance criteria.

The document states: "A biocompatibility, MR safety / compatibility and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices." This indicates that these evaluations were performed, and the results supported substantial equivalence, but the specific acceptance criteria and the detailed performance results are not presented in this summary. It emphasizes "substantial equivalence" rather than a detailed performance study against defined acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.

Here's what can be inferred/noted based on the provided text, and what cannot be provided:

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

• Cannot be provided. The document does not list specific acceptance criteria or detailed performance data from a study. It only mentions that certain evaluations (biocompatibility, MR safety/compatibility, sterilization, packaging/shelf life) were performed and supported substantial equivalence.

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

• Cannot be provided. The document does not describe a clinical or performance study with a test set, sample size, 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):

• Cannot be provided. This information pertains to a study with a ground truth, which is not detailed in the provided text.

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

• Cannot be provided. This information is relevant to a study with multiple readers and ground truth establishment, which is not 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:

• Cannot be provided. The device is a physical medical device (fiducial marker), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed/described.

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

• Cannot be provided. The device is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.

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

• Cannot be provided. This information pertains to a study with a ground truth, which is not detailed in the provided text.

8. The sample size for the training set:

• Cannot be provided. The document describes a physical device, not a machine learning model requiring a training set.

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

• Cannot be provided. Not applicable for this type of device.

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