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510(k) Data Aggregation
(125 days)
HYDROMARK BIOPSY SITE MARKER
The Biopsy Sciences LLC HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible uneler ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The Biopsy Sciences HydroMark Biospy Site Markers are made of The Bropsy Deleal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark also contains a titanium coil that provides permanent visibility under xray and MRI. The HydroMark Site Marker is provided pre-loaded in a sterile, The Hydroman's Stor that is compatible with the J&J Ethicon disposaore applicator tome probe. The HydroMark is deployed by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the HydroMark Biopsy Site Marker:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria with reported performance metrics. However, based on the "Intended Use" and "Technological Characteristics" sections, we can infer the implied acceptance criteria and the claims made about the device's performance.
| Criterion | Reported Device Performance/Claimed Characteristic |
|---|---|
| Mark tissue during a percutaneous breast biopsy | The hydrogel component expands on fluid contact to fill the void created during the biopsy, leaving the HydroMark at the exact location of biopsy. Non-clinical and animal test results demonstrate the HydroMark accurately marks the biopsy site. |
| Visible under ultrasound for at least 6 weeks | The HydroMark is highly visible under ultrasound imaging. Because the hydrogel is hydrophilic, it is clearly distinct from normal breast structure under ultrasound imaging. |
| Permanently visible by X-ray | The HydroMark also contains a titanium coil that provides permanent visibility under x-ray. The hydrogel material degrades via hydrolysis over time leaving the internal Titanium coil which provides permanent visibility under x-ray. The HydroMark assures permanent visibility under x-ray. |
| Permanently visible by MRI | The HydroMark is visible under magnetic resonance imaging. The HydroMark also contains a titanium coil that provides permanent visibility under MRI. The HydroMark assures permanent visibility under MRI with minimal artifacts. |
| Does not migrate | Non-clinical testing included evidence that the site marker does not migrate over time. The HydroMark does not migrate. |
| Biocompatible | Non-clinical testing included biocompatibility of the components. |
| Delivery system compatible with Mammotome probe | Non-clinical testing included validation that delivery system is compatible with the commercially available Mammotome biopsy probe. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in the context of human clinical trials for establishing performance metrics against acceptance criteria. The testing described is primarily non-clinical and animal testing.
- Test Set Sample Size: Not specified for human clinical data. The studies mentioned are non-clinical and animal studies.
- Data Provenance: The document does not specify the country of origin for the animal studies or any human clinical data that might have been used in a "test set." It can be inferred that these studies were likely conducted in the US, given the submission to the FDA. The studies are prospective in nature, as they involve testing the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the primary evidence cited is non-clinical and animal testing, there is no mention of experts establishing a ground truth for a human test set. The evaluation of visibility, migration, and accurate marking in animal studies would have likely been performed by researchers and veterinarians, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
As there is no mention of a human clinical test set requiring expert ground truth, no adjudication method (like 2+1 or 3+1) is described. The evaluation in non-clinical and animal studies would follow experimental protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned. This document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical and animal performance data, rather than comparative effectiveness studies with human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone study (algorithm only) was not performed. The HydroMark Biopsy Site Marker is a physical medical device, not an AI algorithm. Therefore, the concept of "algorithm only" performance does not apply. The performance is intrinsically linked to the physical properties of the marker and its interaction with biological tissue and imaging modalities.
7. Type of Ground Truth Used
The ground truth for the claims made is established through:
- Direct Observation/Measurement in Non-Clinical Testing: For biocompatibility, delivery system compatibility, and migration.
- Imaging Observations in Animal Studies: For accurate marking, visibility under ultrasound, X-ray, and MRI, and assessment of migration.
- Material Science/Chemical Properties: For the degradation of the hydrogel via hydrolysis and the permanent visibility of the titanium coil.
8. Sample Size for the Training Set
This product is a physical medical device, not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of AI does not apply.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this device. The development and verification of the device's properties would involve standard engineering, material science, and biological testing methodologies rather than AI-specific training paradigms.
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