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The EnCor Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. It 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 EnCor Breast 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 EnCor Breast Biopsy System with its 7 and 10-Gauge biopsy probes has the following similarities with the predicate devices: same intended use; same design; same patient contacting materials; same operating principle; and same technological characteristics.

This 510(k) summary (K093512) for the SenoRx EnCor Breast Biopsy System does not contain a description of acceptance criteria or a study proving that the device meets specific performance criteria in the way a diagnostic or AI-enabled device submission would.

Instead, this submission is for a biopsy device and focuses on establishing substantial equivalence to previously cleared predicate devices, particularly for an expanded indication for use (palpable abnormalities). For a device like this, the assessment is typically based on design, operating principle, materials, and intended use being similar to existing cleared devices, rather than measuring performance against a predefined numerical acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, or MRMC studies are not applicable or not present in this type of submission for a physical biopsy device.

Here's a breakdown of the available information based on your request, highlighting what is included and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission for a biopsy device. The basis for clearance is substantial equivalence to predicate devices, not performance against specific numerical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no mention of a "test set" in the context of evaluating performance for this device, as the submission relies on substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. There is no "ground truth" to be established by experts for performance evaluation in this submission. The device's function is to collect tissue, and its equivalence is deemed sufficient by comparison to predicates.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-enabled device or an image analysis device that would be subject to MRMC studies. It is a physical biopsy instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

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

7. The Type of Ground Truth Used

Not applicable. As this is not a diagnostic device assessing an outcome, there isn't a "ground truth" in the typical sense of a diagnostic study (e.g., pathology, outcomes data). The basis for the device's function is its ability to retrieve tissue, and its safety and effectiveness are established via substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not a machine learning or AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the Submission's Approach:

The 510(k) K093512 for the EnCor Breast Biopsy System establishes substantial equivalence to predicate devices (KNW K040842, K003297, K030472, K051158). The key argument for substantial equivalence is based on the following similarities:

• Same intended use (with a modification to include palpable abnormalities, which is justified by matching predicate device indications).
• Same design.
• Same patient contacting materials.
• Same operating principle.
• Same technological characteristics.

This approach allows the device to be marketed without requiring new clinical performance studies or specific numerical acceptance criteria, as its safety and effectiveness are inferred from the safety and effectiveness of the legally marketed predicate devices.

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