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The Bard® Mission® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.

The subject device BARD® MISSION® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g. yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, and green = 14 gauge.

The provided text describes the 510(k) submission for the Bard® Mission® Disposable Core Biopsy Instrument. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility.

Crucially, this document does not contain information about a study involving AI assistance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by human experts for an algorithm's performance. The device in question is a physical medical instrument for obtaining biopsy samples, not a diagnostic imaging AI or similar software.

Therefore, many of the requested criteria regarding AI performance, human reader improvement, expert consensus, and ground truth establishment for a diagnostic algorithm are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and performance based on the non-clinical (bench) testing described in the 510(k) summary.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document states: "The subject device, BARD® MISSION® Disposable Core Biopsy Instrument, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

While specific numerical acceptance criteria and their corresponding reported performance values are not explicitly detailed in a table, the document lists the in vitro tests performed and generally states that the device "performed as expected."

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify exact numerical sample sizes for each in vitro test. It broadly refers to "the subject device BARD® MISSION®" being tested.
• Data Provenance: The tests are described as "in vitro tests," meaning they were performed in a lab setting (bench testing) rather than on human or animal subjects. The provenance is internal testing performed by C.R. Bard. The document does not specify a country of origin for these specific tests, but the submission is to the US FDA. The testing is prospective in the sense of being performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This document describes the performance of a physical biopsy instrument through bench testing, not a diagnostic algorithm requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these engineering tests would simply be the objective measurements and adherence to specifications.

4. Adjudication method for the test set:

• Not Applicable. As above, this is about physical instrument performance tests, not diagnostic interpretations requiring adjudication.

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 physical core biopsy instrument, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used:

• For the physical tests, the "ground truth" is based on engineering specifications, measurements, and established testing protocols (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" in the sense of interpreting images for diagnosis.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI model requiring a training set.

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

• Not Applicable. As above, no training set for an AI model.

In summary, the provided document focuses on the substantial equivalence of a physical medical device (biopsy instrument) based on non-clinical (bench) performance testing and biocompatibility, as opposed to the performance of a diagnostic AI algorithm.

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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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