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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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