(161 days)
The indications statement for the New Device and the Predicate Devices is the same. All of the devices are used for approximating tissue and affixing prosthetic material. Both endoscopic and open procedures.
The GSI Fixation System and the predicate devices are endoscopic multi-fire, fastening systems. The New Device and the Predicate Devices are single patient use, disposable and supplied sterile, with the exception of the Origin Tacker System which is supplied in two parts: the fastener cartridge is single use, disposable and the handle is reusable.
I am sorry, but the provided text does not contain specific acceptance criteria or details about a study proving the device meets them. The document is a 510(k) summary for a "Fixation System," primarily focusing on its substantial equivalence to predicate devices and its intended use. It does not include information about performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.