(8 days)
The Biopsy Sciences LLC., HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The Biopsy Sciences HydroMark Breast Biopsy Site Markers are made of desiccated hydrogel embedded with either a stainless steel or titanium coil. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark Site Marker is currently provided pre-loaded in a sterile, disposable, flexible plastic syringe-like applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. Two modified applicators have been developed which are both 15 gauge stainless steel syringe-like applicators. One has cm markings and a beveled tip to aid in needle placement by direct puncture, or to fit inside a 13 gauge or larger coaxial needle. The distal tip of the applicator is etched to enhance its visibility under ultrasound guidance. An additional stainless steel applicator has been developed to be compatible with the Suros 12 gauge biopsy system. The hydrogel portion of the HydroMark Breast Biopsy Site Marker has a dimensional change to accommodate the 15 gauge applicators, which by design create smaller cavities. The titanium and stainless steel coils embedded in the hydrogel are identical to the original device.
The provided text describes modifications to an existing device (HydroMark Breast Biopsy Site Marker) and its substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new device.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in the provided document. The document focuses on regulatory approval (510(k)) based on modifications to an already approved device and its substantial equivalence to predicate devices.
However, I can extract the stated Intended Use which can be interpreted as the functional performance expected from the device, and the general conclusion regarding meeting design criteria.
Here's a breakdown of what can be inferred or is missing, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, it defines the intended use which implies the performance expectations. The "reported device performance" is essentially the claim that the device, with modifications, still meets these intended uses.
| Acceptance Criterion (Inferred from Intended Use) | Reported Device Performance (Claimed) |
|---|---|
| Intended to mark tissue during a percutaneous breast biopsy procedure | The HydroMark is clearly stated as "intended to mark tissue during a percutaneous breast biopsy procedure." |
| Be visible under ultrasound for at least 6 weeks | The HydroMark is stated as "be visible under ultrasound for at least 6 weeks." The hydrogel component is described as "clearly distinct from normal breast structure under ultrasound imaging." |
| Be permanently visible by x-ray and MRI | The HydroMark is stated as "be permanently visible by x-ray and MRI." The metallic coil provides "permanent visibility under x-ray and MRI." |
| Compatibility with specific applicators (modified) | Risk analysis identified tests for compatibility; these tests "were conducted and established that the HydroMark Breast Biopsy Site Markers in their modified applicators meet the design input criteria." |
| Compatibility of applicators with coaxial needles and Suros biopsy device | Risk analysis identified tests for compatibility; these tests "were conducted and established that the HydroMark Breast Biopsy Site Markers in their modified applicators meet the design input criteria." |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document describes a 510(k) submission for device modifications based on non-clinical performance data (bench testing related to compatibility) and substantial equivalence to predicate devices. It does not mention a clinical test set with human subjects to evaluate imaging visibility in a patient population. The data provenance is internal testing by Biopsy Sciences, Inc. for design verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No clinical test set with a need for expert-established ground truth is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set requiring adjudication 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
Not applicable. This document pertains to a physical medical device (biopsy marker), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device (biopsy marker), not an AI algorithm. Therefore, no standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided for clinical performance. For the non-clinical performance data (compatibility), the ground truth would be established by engineering specifications and successful function during testing.
8. The sample size for the training set
Not applicable/Not provided. This document does not describe the development or training of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable/Not provided. This document does not describe the development or training of an AI algorithm.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.