(91 days)
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 HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking.
The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure.
The Biopsy Sciences HydroMark Breast Biopsy Site Markers will have a change in vendor for the supplier of the hydrogel material. The change in the supplier of the hydrogel has no effect on the finished product specifications.
The provided document is a 510(k) summary for the HYDROMARK BIOPSY SITE MARKER. It describes a device that marks breast tissue during a percutaneous biopsy procedure. It does not contain information about an AI/ML device or its performance criteria. Instead, it focuses on the substantial equivalence of an updated version of an existing medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for an AI/ML device, as these details are not present in the provided text.
The document indicates that "Non-clinical testing included physical, functional and biocompatibility of the finished products manufactured in a newly qualified facility, using hydrogel material from a new supplier. The devices performed as intended according to the original specifications established for the finished device." However, specific acceptance criteria values or detailed performance metrics are not provided in this summary.
§ 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.