(27 days)
The Natural Orifice Linear Cutter Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
The device described here is a Natural Orifice Linear Cutter Digital Loading Unit ® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transections and the creation of anastomoses.
I am sorry, but the provided text from K063075 does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.
The document is a 510(k) summary for a medical device (Natural Orifice Linear Cutter Digital Loading Units®), focusing on its substantial equivalence to a predicate device. It describes:
- Submitter information
- Device name and classification
- Predicate device
- Device description
- Device modification (changes from the predicate device)
- Indications for Use
- Comparison to predicate devices
It explicitly states that the modifications are related to the handle, shaft, and anvil material, and that the device "cuts and staples identically to the predicate device." It also notes that the indications for use are identical to the predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from this document. This typically falls under validation testing, which is often referenced in a 510(k) but the detailed results and criteria are not usually included in the summary itself.
§ 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.