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

The HydroMARK™ Plus Breast Biopsy Site Marker contains a two-component implantable 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 implantable component of the HydroMARK™ Plus Biopsy Site Marker is supplied preloaded 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 provided text is a 510(k) Summary for the HydroMARK™ Plus Breast Biopsy Site Marker, seeking to establish substantial equivalence to a predicate device (HydroMARK™ Breast Biopsy Site Marker). It details various performance and biocompatibility tests conducted to demonstrate this equivalence, rather than providing the kind of robust clinical study data typically associated with an AI/ML device approval that would include information on expert reader performance, ground truth establishment, and training/test set details as requested in the prompt.

Therefore, much of the requested information regarding AI/ML-specific study design (such as number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, and training/test set details for AI models) is not applicable to this submission, as it describes a physical medical device (a biopsy site marker) and its performance, not an AI/ML diagnostic or assistive tool.

However, I can extract the relevant acceptance criteria and reported device performance from the provided document, relating to the physical device itself.

Here's the breakdown based on the provided text, focusing on the device's performance characteristics as a physical marker:

1. A table of acceptance criteria and the reported device performance:

Since this is a physical device and not an AI/ML algorithm, the "acceptance criteria" are derived from the "Indications for Use" and various performance tests aiming to demonstrate substantial equivalence to the predicate device. The performance is reported as meeting these criteria, often by demonstrating equivalence or acceptable results compared to the predicate or relevant standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not directly specified in terms of "cases" like in an AI/ML study, but performance and biocompatibility tests were conducted. For instance:
  • Implantation Data: Refers to "All animals survived" and "no abnormalities or adverse reactions were observed at necroscopy" for the HydroMARK Plus Implantation Data. The specific number of animals is not provided in this summary. It mentions "standard muscle implantation and lymph node sites" for HydroMARK device data and "additional implantation study" for HydroMARK Plus.
  • Residual Moisture, Time to Equilibrium, Toxicity, Pyrogenicity, Irritation, Sensitization: These are laboratory bench tests and animal studies. Specific sample sizes (e.g., number of test articles or animals per test) are not detailed in this summary document, but results are reported as "PASSED."
• Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "Non-Clinical Bench Performance Data" and "Biological Evaluation Testing," which are typically laboratory or animal studies, not human clinical trials. They would be prospective in the sense of being planned tests on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a physical device submission, not an AI/ML diagnostic. "Ground truth" for this device relates to physical and biological properties (e.g., material composition, sterility, biocompatibility, physical expansion, visibility under imaging modalities) established through engineering specifications, laboratory tests, and animal studies, not human expert reader consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are relevant for human reader studies, typically in AI/ML performance evaluations. The presented data is from bench and animal testing.

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. No MRMC study was done, as this is not an AI/ML device for diagnostic assistance.

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

• Not Applicable. This refers to a physical medical device, not an algorithm.

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

• The "ground truth" for this medical device is established through:
  • Physical and Chemical Benchmarking: Direct measurements of material properties, expansion rates, and stability.
  • Biological/Toxicological Standards: Compliance with ISO 10993 series for biocompatibility, using laboratory assays and animal studies to assess absence of toxicity, irritation, sensitization, and pyrogenicity, and demonstration of acceptable local tissue effects upon implantation over time.
  • Imaging Visibility: Demonstration of visibility under ultrasound (acute and long-term), x-ray, and MRI, likely through phantom studies or animal imaging.
  • Engineering Specifications: Adherence to design requirements, manufacturing processes, and sterilization validation.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML system requiring a training set. The device was developed through traditional engineering and material science principles.

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

• Not Applicable. No training set for an AI model. "Ground truth" for manufacturing and design would be established through material specifications, quality control, and adherence to established engineering principles and medical device standards.

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