(29 days)
The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
BiomarC Gold is a sterile, nonpyrogenic, single use tissue marker consisting of 99.99% metallic gold clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound BiomarC Gold is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
The provided text is a 510(k) summary for the BiomarC Gold Tissue Marker. It explicitly states that the technological characteristics are equivalent to predicate devices and that "Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate devices."
However, the summary does not contain the specific information requested regarding acceptance criteria, reported device performance data, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of comparative effectiveness or standalone studies.
Therefore, I cannot provide a table of acceptance criteria and device performance, or answer the other specific questions about study details from the provided text. The document indicates that bench testing was performed, but it does not detail the results of that testing.
§ 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.