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The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray, and MRI.

The LumiMARK™ Biopsy Site Marker implant component [subject device] is composed of a nitinol (nickel/titanium alloy) material versus HydroMARK™ Breast Biopsy Site Marker [predicate device] which is composed of titanium or stainless steel encapsulated in resorbable hydrogel. The marker is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that allows the marker to be inserted with direct puncture under ultrasound. The applicator system is of similar design and materials as the currently marketed Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].

LumiMARK™ Biopsy Site Markers will be available in three different shapes. These permanently visible, implantable markers will allow the physician to identify different biopsied sites under ultrasound, x-ray, and MRI. A similar marker device commercialized by Devicor Medical Products, Inc. is already available (under K212158), and this HydroMARK™ Breast Biopsy Marker [predicate].

The deployment system used for the LumiMARK™ Biopsy Site Marker device [subject] will be similar to the HydroMARK™ Breast Biopsy Site Marker [predicate] delivery system with minor design changes to the plunger assembly and cannula. The nitinol markers will be intended for direct puncture or insertion through another introducer needle that is already in the breast or axillary lymph node.

The provided text describes the regulatory clearance of a medical device, the LumiMARK™ Biopsy Site Marker, and asserts its substantial equivalence (SE) to a predicate device, the HydroMARK™ Breast Biopsy Site Marker (K212158).

However, the text does not contain information about acceptance criteria, reported device performance in those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training sets.

The document focuses on "Performance Testing" and "Biocompatibility Testing" as part of verification data to support substantial equivalence. For both categories, the reported result is "PASSED" and a general statement that "The results of all performance testing met acceptance criteria." However, the specific acceptance criteria themselves, and the quantitative performance metrics attained, are not detailed.

It also explicitly states that the "fundamental scientific technology when compared to the HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] has not changed," and that the "minor differences between the subject device and predicate device do not raise concerns of safety and effectiveness." This suggests that the demonstration of substantial equivalence relies heavily on the similarity to the already cleared predicate device, rather than extensive de novo clinical studies with detailed performance metrics.

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The document states "Performance Testing was conducted," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not provided. The testing described is primarily bench performance and biocompatibility, not clinical studies requiring expert ground truth establishment in the traditional sense for diagnostic AI tools.

4. Adjudication method for the test set:

• Not applicable/Not provided. No clinical test set requiring adjudication by experts is described.

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 such study was done or mentioned. This device is an implantable biopsy site marker, not an AI-powered diagnostic tool, so MRMC studies for AI assistance are not relevant to its clearance.

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

• Not applicable/Not provided. This device is a physical implantable marker and does not involve an algorithm for standalone performance.

7. The type of ground truth used:

• For "Performance Testing" and "Biocompatibility Testing," the "ground truth" would be established by objective measurements and adherence to specified scientific and engineering standards (e.g., mechanical properties, chemical composition, biological response) rather than expert consensus on medical images or pathology. The text indicates use of standards like ISO 13485, ISO 14971, and ISO 10993 series for these tests.

8. The sample size for the training set:

• Not applicable/Not provided. This device is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

• Not applicable/Not provided. (As it's not an AI model, there's no training set or ground truth in this context.)

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