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The Rubicor Magic ™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Rubicor Magic ™ Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the 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.

The Rubicor Magic Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes an 8 cm long, 10 gauge, stainless steel coring cannula and a sharp stylet that runs through the center of the cannula and extends from its distal end. The handle of the device contains an actuation button, two indicator lights, a removable sample collection chamber, a drive mechanism for advancing and rotating the coring cannula and transporting the core specimen to the collection chamber, a DC motor, and a 9 V battery.

The provided 510(k) summary for the Rubicor Magic™ Breast Biopsy Device does not contain detailed acceptance criteria, specific study results, or information regarding a comparative effectiveness study (MRMC). The document states that "Results of in-vitro testing demonstrate that the Rubicor Magic Breast Biopsy Device is safe and effective for its intended function," and that the materials used meet ISO 10993-1 for biocompatibility. However, it does not provide quantitative performance metrics, sample sizes for test or training sets, details about ground truth establishment, or expert qualifications.

Based on the provided text, here is what can be extracted and what information is missing:

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

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

• Sample Size for Test Set: Not specified. The document only mentions "in-vitro testing."
• Data Provenance: Not specified. The testing is described as "in-vitro," which typically refers to laboratory-based testing rather than clinical data from human subjects.

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. As the testing was "in-vitro," it would not involve human experts establishing ground truth in the context of clinical images or pathological samples in the same way an AI diagnostic device would.

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

• Not applicable. This device is a biopsy instrument, not an AI diagnostic system requiring adjudication of interpretations.

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

• No. An MRMC study was not done. The device is a physical biopsy instrument, not an AI diagnostic system intended to assist human readers.

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

• Not applicable. This device is a physical biopsy instrument, not a standalone AI algorithm. The performance mentioned refers to the physical operation of the device (e.g., ability to core tissue, mechanism function).

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

• For "in-vitro testing," ground truth would likely refer to engineering specifications, mechanical performance targets, and material properties. The document does not specify the exact type of "ground truth" or reference standard used to evaluate the device's efficacy in obtaining diagnostic samples in the in-vitro setting. It does mention that the device is "designed to provide breast tissue for histologic examination," implying the ultimate goal is tissue suitable for pathology, but the "in-vitro" nature of the test means this wasn't tested with actual pathology outcomes from human biopsies.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not an AI system that requires a training set.

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

• Not applicable. This document describes a physical medical device, not an AI system.

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