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[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

[Trade Name] Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. The [Trade Name] Preloaded Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

This device is a tissue marker, not an AI/ML device, so many of the requested elements pertaining to AI/ML device studies (e.g., test set, training set, ground truth experts, MRMC study, standalone performance) are not applicable or detailed in the provided documents. The provided text outlines a 510(k) summary for a medical device called the "[Trade Name] Preloaded Tissue Marker Device" and its associated FDA clearance letter.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable in the context of an AI/ML device. For this physical medical device, specific sample sizes for each type of testing (biocompatibility, sterility, etc.) are not provided in the summary. Data provenance is implied to be from laboratory and engineering testing.

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

• Not applicable as this is not an AI/ML device study.

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

• Not applicable as this is not an AI/ML device study.

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:

• No, an MRMC comparative effectiveness study was not done, as this is not an AI/ML device.

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

• No, as this is not an AI/ML device. Performance was evaluated for the device itself through various engineering and scientific tests.

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

• For this type of medical device, "ground truth" refers to established scientific and engineering standards and tests. The "ground truth" for the acceptance criteria was based on:
  • Predicate Device Equivalence: The performance and characteristics of the already cleared predicate devices.
  • Standardized Testing: Biocompatibility standards, sterility validation protocols, distribution simulation standards, and shelf life testing protocols.
  • Risk Analysis: Failure Modes and Effects Analysis (FMEA).

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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The BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The BiomarC Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use delivery system incorporating the BiomarC tissue marker consisting of a non-absorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. The BiomarC Tissue Marker is delivered either with an obterator or with the BiomarC BiomarC is placed into soft tissue during open, percutaneous, or Delivery Gel. endoscopic procedures to radiographically mark a location.

The provided document does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria. It is a 510(k) summary for the BiomarC® Preloaded Tissue Marker Device, which primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the limited information, here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document states "Bench testing has demonstrated..." but does not specify the sample size, type of test set (e.g., human subjects, cadaveric, in-vitro materials), or data provenance.

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

• Not applicable/Not provided. The document refers to "Bench testing," which typically does not involve human experts establishing ground truth in the same way clinical studies or image-based diagnostic AI studies do.

4. Adjudication method for the test set

• Not applicable/Not provided. No adjudication method is mentioned, as the evaluation appears to be based on bench testing rather than expert-reviewed data.

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

• No. This is not an AI-powered diagnostic device. It is a physical medical device (tissue marker). Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or described.

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

• Not applicable. This is a physical tissue marker, not an algorithm.

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

• Likely engineering specifications/performance metrics. Based on "Bench testing," the ground truth would typically be established by measurable engineering specifications (e.g., material compatibility, visibility under imaging modalities, marker retention, deployment force) that demonstrably align with the predicate device's performance. No specific type of ground truth beyond this is mentioned.

8. The sample size for the training set

• Not applicable/Not provided. As this is not an AI/ML device, there is no "training set."

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

• Not applicable/Not provided.

Summary of the Study:

The document mentions "Bench testing" as the study conducted to demonstrate the device's safety, effectiveness, and substantial equivalence to the predicate device. However, it provides no details about the methodology, specific tests performed, sample sizes, data, or results of this bench testing. The conclusion of these tests was that:

• The technological characteristics are equivalent to the predicate device.
• The device is safe and effective.
• Its performance is substantially equivalent to the predicate device.

The entire 510(k) submission hinges on demonstrating this "substantial equivalence" to a legally marketed predicate device (Promex Biopsy Site Tissue Marker Device K023450 and BiomarC Tissue Marker K032347) rather than meeting novel, predefined acceptance criteria through an extensive clinical trial.

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