(21 days)
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
The provided text is a 510(k) summary for the "Auto Suture™ ENDO CLIP™ III 5mm Clip Applier," a surgical device. It does not describe a study involving an algorithm or AI. Therefore, I cannot extract information related to acceptance criteria and device performance in the context of an AI/algorithm-based device.
The document discusses:
- The device's intended use (occlusion of blood vessels, ducts, and other tubular structures during laparoscopic surgery).
- Its technological characteristics (identical to predicate devices).
- Materials used (biocompatible).
- Performance data states that "In-vitro and in-vivo tests were performed to verify that the ENDO CLIP™ III 5mm Clip Applier was substantially equivalent to the predicate devices in occluding vessels and other tubular structures and to validate that the ENDO CLIP™ III 5mm Clip Applier performed as intended."
However, this paragraph does not provide any specific acceptance criteria (numerical thresholds) or reported device performance metrics (e.g., success rates, occlusion strength, or specific measurements) that could be tabulated. It only broadly states that tests were performed to demonstrate substantial equivalence and intended performance.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, ground truth establishment, expert involvement, or MRMC studies, as these relate to the evaluation of an AI/algorithm, which is not the subject of this document.
§ 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.