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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, ultrasound 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) premarket notification for the BiomarC Fiducial Marker, an existing device that has undergone modifications. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed clinical study data for acceptance criteria.

Therefore, the information required to fully answer the request, such as a detailed table of acceptance criteria with reported device performance, sample sizes for test and training sets, specifics on ground truth establishment involving expert consensus, MRMC study results, or standalone algorithm performance, is not present in this submission.

The document states that the "Technological Characteristics and Performance" of the modified device are "equivalent to the predicate devices." This implies that the device is not undergoing a new clinical validation study to establish novel performance metrics but rather confirming that its modified design does not negatively impact existing, previously proven performance.

Here's what can be extracted and inferred based on the provided document:

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

Based on the nature of a 510(k) for a modified device, the "acceptance criteria" appear to be related to demonstrating the continued equivalence of key characteristics and performance aspects to the predicate devices. The document states:

Notes:

• The reported performance is a declaration of substantial equivalence, not quantitative metrics from a new clinical study.
• The "study that proves the device meets the acceptance criteria" in this context refers to the evaluations performed for the 510(k) submission, confirming that the modifications do not alter the substantial equivalence for these key characteristics. These are likely internal testing activities rather than large-scale clinical trials.

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. For a 510(k) of a modified device, the "test set" would primarily refer to engineering and bench testing rather than a clinical dataset.
• Data Provenance: Not specified. Again, likely internal testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document does not describe the establishment of a "ground truth" using experts for a test set in the context of an AI-driven device or diagnostic study. This approval is for a physical medical device (fiducial marker), not an AI algorithm.

4. Adjudication method for the test set:

• Not applicable, as there's no mention of a clinical test set requiring expert adjudication for ground truth.

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 approval is for a fiducial marker, not an AI-assisted diagnostic or assistive tool.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• For a physical device like a fiducial marker, "ground truth" would relate to its physical properties and measurable performance characteristics (e.g., visibility, biocompatibility, MRI compatibility). The "ground truth" for the equivalence claim is the performance data of the predicate devices. The current submission confirms that the modified device's performance matches that established "ground truth" of the predicates.

8. The sample size for the training set:

• Not applicable. There is no AI training set mentioned as this is not an AI device.

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

• Not applicable.

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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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The BiomarC Gold 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 Gold Fiducial Marker is a sterile, pyrogen free, single patient use, gold discrete marker that is visible on standard radiographs, ultrasound 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 Gold Fiducial Marker, which is a device intended for use in stereotactic radiosurgery and radiotherapy. This summary focuses on demonstrating equivalence to predicate devices and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report for an AI/ML-driven diagnostic device.

Therefore, I cannot provide the information requested in your prompt based on the input provided.

The document states:

• "The technological characteristics are equivalent to the predicate devices."
• "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced."
• "A biocompatibility, visibility, and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Gold Fiducial Marker, was substantially equivalent to the predicate devices."

These statements indicate that the evaluation focused on device characteristics and equivalence, not on a detailed performance study with specific metrics as if it were an AI diagnostic tool.

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