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The EnCapsule™ 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 EnCapsule 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.

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The provided text is a 510(k) summary for the Rubicor EnCapsule™ Breast Biopsy Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a modern AI/ML device submission would.

Therefore, much of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be extracted:

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

• Acceptance Criteria: Not explicitly stated. For this type of device (a biopsy device), acceptance criteria would likely revolve around mechanical performance, accuracy of tissue acquisition, safety (e.g., integrity of the device, absence of harmful interactions with the body), and biological compatibility.
• Reported Device Performance: The document states: "Results of in-vitro testing demonstrate that the Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function." However, no specific performance metrics (e.g., amount of tissue collected, success rate of biopsy, complication rates) are provided.

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

• Sample Size: Not mentioned.
• Data Provenance: The study mentioned is "in-vitro testing," which typically means laboratory-based testing on non-human materials (e.g., tissue phantoms or excised tissue). No country of origin is specified. The nature of "in-vitro" suggests this would be a controlled environment rather than retrospective or prospective patient data.

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 this is an in-vitro performance test for a mechanical device, not a diagnostic AI/ML algorithm requiring expert interpretation of medical images. Ground truth for a biopsy device would be related to its mechanical function, tissue recovery, and safety.

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

• Not applicable for an in-vitro performance test of a mechanical device.

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. This is a breast biopsy device, not an AI/ML diagnostic tool meant for human reader assistance.

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 consensus, pathology, outcomes data, etc)

• For "in-vitro testing" of a biopsy device, ground truth would likely refer to objective measurements of the device's function, such as:
  • Confirmation of successful tissue acquisition (e.g., visual inspection, weighing tissue samples).
  • Mechanical integrity of the device before, during, and after use.
  • Absence of material degradation or unwanted interactions.
  • Compliance with design specifications.
  • No expert consensus, pathology, or outcomes data are mentioned for establishing ground truth of the device's performance in this context.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

In summary, the provided document is a 510(k) summary for a physical medical device (breast biopsy tool). It confirms that "in-vitro testing" was performed and deemed the device "safe and effective for its intended function," leading to a determination of substantial equivalence to predicate devices. However, it does not provide the detailed study results, acceptance criteria, or ground truth methodology that would be expected for an AI/ML device submission, due to the nature of the product.

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