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The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.

The HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird, subject device) is a two-component marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed. The HydroMARK™ Plus Breast Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue requires surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer or by direct puncture into the biopsy cavity created by the breast biopsy device.

The HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird shape) does not involve AI. The provided text describes a medical device, a breast biopsy site marker, and its substantial equivalence to a predicate device. None of the listed points (acceptance criteria, device performance, sample size, ground truth, experts, adjudication, MRMC study, standalone performance, training set, or ground truth for training) are relevant to this type of device submission, especially concerning AI/ML aspects.

The submission focuses on establishing substantial equivalence to a legally marketed predicate device (HydroMARK™ Plus Breast Biopsy Site Marker with a Dragonfly shape, K221961) based on similar design, functionality, performance, and materials.

The key acceptance criteria and performance data for this device are related to its physical characteristics and biological compatibility, rather than AI model performance metrics.

Here's a summary of the relevant information provided, structured to respond to the prompt as closely as possible, even though AI/ML specific information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for performance testing. It states that "Performance Testing was conducted" and "The results of all performance testing met acceptance criteria." The provenance is not explicitly mentioned but is implied to be from the manufacturer's internal testing as part of their ISO 13485:2016 compliant Quality Management System. This type of device does not typically involve clinical data from patients or diverse populations for basic substantial equivalence claims like this.

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

Not applicable. This device is a physical marker and its performance evaluation involves objective physical, chemical, and biological tests rather than interpretation by human experts to establish ground truth for a test set in the context of AI/ML.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human interpretation or multi-reader studies, which are not described for this 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

Not applicable. This device is not an AI-powered diagnostic tool, and therefore, no MRMC study was conducted in relation to AI assistance.

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

Not applicable. This device is not an algorithm or software requiring standalone performance evaluation in the context of AI/ML.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance would be derived from objective engineering, material, and biocompatibility testing standards. For instance:

• Visibility: Confirmed through imaging techniques (ultrasound, X-ray, MRI) in a controlled setting or phantom, comparing against known visual properties.
• Biocompatibility: Determined by adherence to ISO 10993 standards through laboratory assays and in-vivo animal studies.
• Deployment Force, Marker Size: Measured quantitatively using calibrated instruments.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set for an AI/ML model.

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

Not applicable. This device does not involve a training set for an AI/ML model.

Conclusion stated in the document: The applicant concluded that the HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird shape) is substantially equivalent to the predicate device (HydroMARK™ Plus Breast Biopsy Site Marker, K221961, Dragonfly shape) based on "similar functional and performance characteristics" and "substantially equivalent design, functionality, and performance characteristics." The "minor differences between the subject device and predicate device regarding marker shape do not raise concerns of safety and effectiveness."

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