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The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

• The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
• The Mammotome Biopsy 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 Biopsy 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 Biopsy System is a mechanical breast biopsy device used in incisional breast biopsy. The Mammotome Biopsy System may be used with imaging guidance (stereotactic or ultrasound).
The Mammotome Biopsy System consists of three major components: a disposable trocar tipped needle-like probe, a reusable holster/cable assembly into which the probes are loaded, and a remote, reusable control module. The system uses vacuum assistance to gather tissue samples and a high-speed rotating cutter. The procedure is referred to as "directional vacuum-assisted biopsy."

The provided text describes the Mammotome Biopsy System and its substantial equivalence to predicate devices, focusing on an updated "Indications for Use." However, it does not contain the detailed acceptance criteria or results of a study designed to prove the device meets specific performance criteria in the format requested.

The document is a 510(k) summary from 2003, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device.

While it mentions "Clinical data from a multicenter study are provided that supports the additional Indications for use," it does not elaborate on:

• Specific acceptance criteria: What quantitative or qualitative metrics defined success for the new indications?
• Reported device performance: What were the results of the multicenter study in relation to these criteria?
• Sample size and data provenance: How many patients were in the study? Where did the data come from? Was it retrospective or prospective?
• Expert details or ground truth establishment: How was the ground truth (e.g., confirmed diagnosis) established for the study cases?
• Adjudication method, MRMC studies, or standalone performance: These specific details about study design are not present.
• Training set details: Since this is a biopsy device and not AI software, the concept of a "training set" in the context of machine learning doesn't apply directly.

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text.

The document primarily states:

• Device: Mammotome Biopsy System
• Predicate Device: Mammotome Biopsy System (K992813) and Mammotome Hand Held System (K991980)
• Change: Only the Indications for Use was changed.
• Evidence for change: "Clinical data from a multicenter study are provided that supports the additional Indications for use."
• Conclusion: The FDA determined the device is substantially equivalent for the specified indications for use.

Without the actual study report or further documentation, it's impossible to extract the precise information you've requested regarding acceptance criteria and performance data.

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