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The Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.

The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

The Bio-MARK biopsy site marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The site markers are deployed through an applicator that fits in the J&J Ethicon Mammotome 11 gauge biopsy probe. The Bio-MARK device marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the marker over time. The Bio-MARK is sold in two styles: the Resorbable Bio-MARK is made of the copolymer only, the Permanent Bio-MARK is identical with the addition of a stainless steel component for permanent radiographic visibility.

Bio-MARK Site Markers are made of 75/25% poly(D,Llactide-co-glycolide) copolymer into which a USP grade contrast agent has been incorporated to provide radiopacity. The markers are deployed into the biopsy needle tract using a hand held applicator with a two finger-push control rod that delivers a single marker.

The Bio-MARK Biopsy Site Marker 510(k) submission (K023694) has limited detail regarding a formal study and acceptance criteria in the provided text. The document focuses on the device description, intended use, and substantial equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria and results.

However, based on the information provided, we can infer some "acceptance criteria" from the stated intended use and technological characteristics, and then identify what the filing states about the device meeting these:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided 510(k) summary does not explicitly state a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective) for a study proving the device meets acceptance criteria. The document relies on describing the device's composition and intended function, asserting that it meets its intended use based on its design and similarity to predicate devices. This type of 510(k) submission typically does not include extensive clinical trial data.

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

The provided document does not mention a test set with ground truth established by experts. No information on the number or qualifications of experts is available.

4. Adjudication Method for the Test Set:

No adjudication method is described, as no formal test set or clinical study requiring adjudication is detailed in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The document does not describe any studies comparing human readers with or without AI assistance. The device is a physical biopsy site marker, not an AI software.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The Bio-MARK is a physical medical device, not an algorithm or AI. Therefore, a standalone algorithm performance study was not conducted or reported.

7. Type of Ground Truth Used:

No explicit "ground truth" as typically understood in AI/imaging studies is detailed. The assessment of the device's performance appears to be based on its material properties (resorbability, radiopacity due to contrast agent/stainless steel) and its intended mechanical function (deployment, visibility over time). This would likely have been verified through bench testing, material science testing, and potentially some in-vivo animal or limited human observational studies (though not detailed here) to confirm visibility and resorption characteristics.

8. Sample Size for the Training Set:

Not applicable. The Bio-MARK is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this device.

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