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The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.

The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop. The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.

This document is not a study, but rather a 510(k) Premarket Notification for a medical device (BiomarC Coaxial Needle). It doesn't contain information about a clinical study with acceptance criteria and reported device performance in the way a traditional clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested fields regarding acceptance criteria, study design, sample sizes, experts, and ground truth are not applicable or cannot be extracted from this type of document.

However, I can extract information related to the device's intended performance and how its characteristics are compared to predicate devices, which implicitly serves as the basis for its safety and effectiveness claims for regulatory purposes.

Here's a breakdown of what can and cannot be extracted:

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

This document does not present explicit "acceptance criteria" and "reported device performance" in the context of a clinical study with measured outcomes against predefined thresholds. Instead, it relies on demonstrating that the proposed device has technological characteristics and performance substantially equivalent to legally marketed predicate devices.

The table below summarizes the comparison between the proposed device and its predicates, which serves as the implicit "proof" of meeting performance expectations for substantial equivalence.

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

• Sample Size: Not applicable. This document does not describe a test set or comparative study with specific sample sizes. The submission relies on a comparison of technological characteristics to predicate devices already on the market.
• Data Provenance: Not applicable. The "study" here is a regulatory submission demonstrating substantial equivalence, not a clinical trial.

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

Not applicable. There was no "test set" requiring ground truth established by experts in the context of a performance study.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication.

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 not an AI/software device and no MRMC study was performed or described.

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

Not applicable. This is a physical medical device (coaxial needle), not an algorithm or AI.

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

Not applicable. There was no "ground truth" in the clinical study sense. The "ground truth" for the device's acceptability is its substantial equivalence to legally marketed devices, implying that their established safety and effectiveness applies to the new device given its similar characteristics and intended use.

8. The sample size for the training set

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no concept of a "training set."

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

Not applicable. See point 8.

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