(21 days)
The Gel Mark IV is intended to radiographically and sonographically mark breast tissue prior to or during a breast biopsy procedure.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Gel Mark IV Tissue Marker". This document explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. It does not contain information about acceptance criteria, a study proving the device meets said criteria, or details regarding performance, sample sizes, expert qualifications, or ground truth establishment.
Instead, a 510(k) clearance is a regulatory pathway that demonstrates a new device is as safe and effective as a legally marketed predicate device. This process typically involves comparisons to existing devices, and often relies on bench testing, in vitro studies, and sometimes clinical data, but it doesn't generally involve the kind of elaborate studies described in your request (e.g., MRMC studies, detailed performance metrics with acceptance criteria, or extensive expert consensus for ground truth). The letter is a confirmation of market authorization based on substantial equivalence, not a detailed study report.
Therefore, I cannot provide the requested information from the given text.
§ 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.