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The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.

The Mammotome is comprised of a disposable needle instrument housing. The Mammotome probe may be used with imaging guidance (such as ultrasound, X-ray, and CT), and it may be either stereotactically mounted or hand held depending on physician preference and the type of tissue sampled. The disposable Mammotome probes are available in various sizes and lengths. The probe components include an outer trocar cannula and a sliding inner hollow coaxial cutter. The trocar cannula incorporates a distal sampling notch and a proximal notch which forms the tissue retrieval chamber. The sampling notch thumbwheel is used to manually turn and orientate the sampling notch as desired.

This document, K920565, describes the Summary of Safety and Effectiveness for the BMI Mammotome, intended for diagnostic sampling of breast tissue during a biopsy procedure. However, it does not contain the kind of performance data usually associated with AI/ML-driven medical devices that would require acceptance criteria and studies proving the device meets those criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity).

The document is a 510(k) premarket notification for a medical device (a biopsy needle), and its focus is on demonstrating substantial equivalence to a predicate device. This involves comparing intended use and technological characteristics, not quantitative performance metrics like those for an AI diagnostic algorithm.

Therefore, most of the requested information cannot be extracted from this document based on the device type and the content provided.

Here's a breakdown of why and what little can be inferred:

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

• Not applicable. This document does not define quantitative performance criteria (e.g., accuracy, sensitivity, specificity) because it's a physical device for tissue sampling, not a diagnostic algorithm. The "performance" being evaluated is substantial equivalence to a predicate device in terms of function and safety, not diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. There is no "test set" in the context of evaluating diagnostic performance from data. The evaluation is based on device design and comparison to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth in the sense of diagnostic accuracy is not established for this type of device in this document.

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

• Not applicable. No test set for diagnostic performance.

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 a mechanical biopsy device, not an AI system. MRMC studies are for evaluating AI's impact on human diagnostic accuracy.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. Ground truth for diagnostic performance is not relevant to this substantial equivalence claim for a biopsy device. The "ground truth" for the device's function is its ability to retrieve tissue, which is inherent in its design and comparison to the predicate.

8. The sample size for the training set

• Not applicable. There is no training set mentioned or implied, as this is not an AI/ML device.

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

• Not applicable. No training set.

Summary of available information from the provided text:

• Device Name: BMI Mammotome
• Intended Use: Diagnostic sampling of breast tissue during a biopsy procedure.
• Predicate Device: Biopsys Medical Needle (intended for removal of soft body tissue for biopsy, definitive diagnosis, or confirmation of a clinical diagnosis).
• Technological Characteristics: Substantially equivalent to the predicate. Made of stainless steel, manually and mechanically pierce tissue, cut tissue with a hollow cutter, collect or eject tissue.
• Mechanism: Disposable probes with an outer trocar cannula and a sliding inner hollow coaxial cutter. Incorporates a distal sampling notch and a proximal notch for tissue retrieval. Sampling notch can be manually oriented.
• Guidance Method: Can be used with imaging guidance (ultrasound, X-ray, CT), stereotactically mounted or hand-held.

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