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The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

• The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
• The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
  The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
  In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is a mechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.
The Mammotome® revolve Dual VAB System is comprised of three primary subsystems:

• 1. a sterile, single-use probe
• 2. a reusable holster, and
• 3. a reusable control unit.

This submission describes the Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System, a mechanical breast biopsy device designed to obtain tissue samples for diagnostic sampling of breast abnormalities. The device is an updated version of the predicate device, the Mammotome® Biopsy System (K033700), with improvements aimed at enhancing efficiency and ease of use while maintaining core technology and clinical outcomes.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The text mentions "side-by-side comparison of tissue sample collection."
• Data Provenance: In vivo porcine model. This indicates the testing was conducted on live animals, not human subjects, and is considered prospective for the purposes of this study as it was performed specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. The study used an in vivo porcine model and evaluated performance based on sample characteristics (weight, reliability, quality) rather than diagnostic accuracy against a human expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This was a performance comparison study in an animal model, not a diagnostic accuracy study requiring adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This submission is for a medical device (biopsy system), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related improvement metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a mechanical biopsy device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth was established by comparing the tissue samples obtained by the proposed device to those obtained by the predicate device based on objective measures of sample weight, sampling reliability, and sample quality. These are direct physical sample characteristics, not a diagnostic "ground truth" in the traditional sense of disease presence/absence.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

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