(27 days)
The Curved Cutter Stapler is intended for use in gastrointestinal surgical procedures for transection and resection of tissues.
The Curved Cutter Stapler is a sterile, single use device with a curved head that cuts and staples. It delivers four staggered rows of titanium staples, two rows on each side of a cut line. The device is supplied with one cartridge and can be reloaded for a total of six (6) firings. The reloads will be available in two sizes: a blue cartridge for compressed tissue with a thickness of 1.5mm, and a green cartridge for compressed tissue with a thickness of 2.0mm.
The provided text is a 510(k) summary for a medical device (Curved Cutter Stapler) and the FDA's clearance letter. It does not describe an AI/ML powered medical device, an "algorithm," "AI assistance," or "human-in-the-loop performance." Therefore, I cannot extract the requested information about acceptance criteria and study details related to an AI/ML device.
The document indicates "Bench and pre-clinical testing was performed to demonstrate that the device performs as intended," but it does not specify the acceptance criteria, the details of these tests, sample sizes, or ground truth establishment relevant to an AI/ML study.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.