(233 days)
The Disposable Anorectal Staplers have application for general treatment of hemorrhoids.
The Disposable Linear Cutting Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
The Disposable Endoscopic Cutting Staplers has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
The Disposable Anorectal Staplers are a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 33mm. The staple size is 4.0mm. It cannot be reloaded.
The Disposable Linear Cutting Stapler places two double-staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutting Staplers is available in 60mm, 80mm and 100mm three specifications, and in two staple sizes 3.8mm and 4.8mm, to accommodate various tissue thickness. Each Disposable Linear Cutting Staplers may be reloaded up to 10 times in a single procedure.
The Disposable Endoscopic Cutting Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.5mm, 4.0mm and 4.8mm. The device may be reloaded and fired up to 10 times in a single procedure.
The provided text describes a 510(k) premarket notification for disposable staplers and does not contain information about an AI/ML device. Therefore, it is not possible to describe the acceptance criteria and study that proves an AI/ML device meets them based on the given input.
The document primarily focuses on demonstrating substantial equivalence of the proposed disposable medical staplers (Disposable Anorectal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers) to existing legally marketed predicate devices. This is achieved through comparisons of technological characteristics, indications for use, and results from non-clinical tests.
The non-clinical tests mentioned include:
- Biocompatibility tests (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, pyrogen, hemolysis).
- Package integrity tests (dye penetration, sealing strength).
- Simulation transportation test.
- Ex-vivo tissue tests on porcine stomach and intestine (Pressure Rest, Closed Staple Dimension Test, Staple Formation Test, Force Required to Fire Stapler Test).
- Jugular vein test on a porcine model for thin tissues (Burst pressure, closed staple height and staple formation).
The document explicitly states: "No clinical study is included in this submission."
Therefore, none of the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training, data provenance, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance can be extracted as it pertains to an AI/ML device.
§ 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.