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The Marquee™ Disposable Core Biopsy Instrument and Kit are intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The coaxial cannula release is color coded according to the various gauge sizes, e.g., yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, green = 14 gauge, and light blue = 12 gauge.

The Marquee™ Disposable Core Biopsy Instrument is available as a biopsy instrument only and as a kit, which includes the Marquee™ Disposable Core Biopsy Instrument and compatible Disposable Coaxial Biopsy Needle.

The provided FDA 510(k) clearance letter for the Marquee™ Disposable Core Biopsy Instruments and Kits does not contain the detailed acceptance criteria and specific study results traditionally associated with the performance of AI/ML-driven medical devices.

This document is for a physical medical device (biopsy instruments and kits) undergoing a "Special 510(k): Device Modification" clearance. As such, the performance data presented focuses on physical characteristics and material compatibility rather than AI/ML model performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will provide a summary based on the information that is available about the device's testing and a table of the acceptance criteria and reported "performance" based on the provided document's context, noting where information is not applicable or not provided.

A. Acceptance Criteria and Reported Device "Performance" (for a physical medical device)

Given that this is a physical biopsy instrument, the "performance" relates to its mechanical and material properties rather than diagnostic accuracy.

B. Study Details (as inferable from the document for a physical device)

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for specific tests (e.g., how many instruments were tested for tensile strength or how many biopsies were taken in ex-vivo tests). The document states "ex-vivo testing was conducted on porcine tissue" using 12G, 14G, and 20G models.
   • Data Provenance: The biocompatibility testing followed ISO 10993-1:2018. The ex-vivo testing was done on "porcine tissue." The context suggests these are laboratory-controlled, prospective tests conducted by the manufacturer, Bard Peripheral Vascular, Inc. No country of origin for the data is specified, but typically, these studies are conducted in the country of the manufacturer or approved testing facilities.

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

   • Not Applicable / Not Provided for this device. For physical devices like biopsy instruments, the "ground truth" is measured against engineering specifications and material properties (e.g., tensile strength, successful sterile barrier). Expert consensus (like in image interpretation) is not directly relevant to these types of performance tests. The ex-vivo tissue quality assessment would likely involve pathologists or relevant subject matter experts, but their number and qualifications are not specified.

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

   • Not Applicable / Not Provided for this device. Adjudication methods like 2+1 are typically used in clinical studies or studies involving subjective human interpretation (e.g., reading medical images). For the mechanical and material tests described, results are objective measurements against predefined specifications.

4. 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/ML device. An MRMC study is completely irrelevant to this type of medical device (physical biopsy instrument).

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

   • No. This is not an AI/ML device. Standalone performance testing refers to the performance of an algorithm without human intervention, which does not apply here.

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

   • For Biocompatibility: Compliance with ISO 10993-1:2018 standards and specific test results (cytotoxicity, sensitization, etc.).
   • For In Vitro Physical Performance: Engineering specifications, design tolerances, and established industry standards for mechanical properties.
   • For Ex-vivo Testing: The "sample quality" on porcine tissue would likely be assessed against histological standards (e.g., tissue integrity, architecture, presence of target cells). Whether this involved expert pathology consensus or objective criteria is not specified, but it would fall under a form of "pathology" ground truth for the sample quality.

7. The sample size for the training set:

   • Not applicable. This device is a physical instrument, not an AI/ML model that requires a training set.

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

   • Not applicable. This device is a physical instrument, not an AI/ML model that requires a training set.

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