Search Results

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.

Ask a specific question about this device