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The Mammotome AutoCore™ Single Insertion Core Biopsy System is indicated to obtain tissue samples from the breast or lymph nodes for diagnostic analysis of breast abnormalities. This instrument is for diagnostic use only and is not indicated for therapeutic use.

The extent of a histologic abnormality cannot always be reliably determined from the 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 benian, it is essential that the tissue marqins be examined for completeness of removal using standard surgical procedures.

The Mammotome AutoCore™ Single Insertion Core Biopsy System is an automated core needle biopsy system. It is a single insertion, multiple sample device that includes automated arming and automated sample collection. It is available in two gauge sizes (12G and 14G) and acquires soft tissue samples using a spring-loaded inner piercing stylet and outer cutting cannula in the probe needle.

The provided text does not contain detailed acceptance criteria or extensive study results that prove the device meets specific performance metrics. It primarily discusses the regulatory submission for the Mammotome AutoCore™ Single Insertion Core Biopsy System.

However, based on the limited information regarding performance testing, here's what can be extracted and inferred:

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

The document mentions several performance tests were conducted. While specific acceptance criteria values are not provided, the table below lists the characteristics tested, which implies that the device met the internal acceptance criteria for each test to achieve substantial equivalence.

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

• Bench Testing: The document does not specify sample sizes for the bench tests (static force, lesion displacement, overmold bond strength, bend load). It also does not specify data provenance or if it was retrospective or prospective.
• Animal Testing: The document does not specify sample sizes for the animal testing. It also does not specify data provenance or if it was retrospective or prospective.

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):

The document does not describe any human expert involvement in establishing ground truth for the performance tests mentioned. The tests appear to be primarily engineering and animal model assessments.

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

No information is provided about adjudication methods for the test sets, as the studies described are not clinical or interpretative in nature where adjudication would typically be relevant.

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. The Mammotome AutoCore™ is a physical biopsy system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be conducted for this device.

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

Not applicable, as this is a physical medical device and not an algorithm.

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

• Bench Performance: For bench tests, the ground truth would be based on engineering specifications and physical measurements, rather than clinical or pathological ground truth as defined in diagnostic studies.
• Animal Performance: For animal testing, the ground truth for "appropriate sample weight, acquisition, and quality" would likely be determined by veterinary pathologists or other trained personnel assessing the biopsy samples obtained from the animal models, comparing them against established criteria for diagnostic-quality tissue samples.

8. The sample size for the training set:

Not applicable. This document describes the regulatory submission for a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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