(30 days)
The reloadable staplers have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
The GIA™ Auto Suture™ Stapler with DST Series™ Technology places two double staggered rows of titanium staples and simultaneously cuts and divides the tissue between the two double rows. The stablers and accompanying single use loading units (SULUs, also referred to as "reloads") are available in 60 mm, and 100 mm lengths. Three staple sizes are available: 2.5 mm, 3.8 mm, and 4.8 mm to accommodate varying tissue thicknesses. The GIA™ stapler may be reloaded with a GIA™ Auto Suture™ Loading Unit with DST Series™ Technology up to 7 times for a total of 8 firings per instrument.
The provided text describes a Special 510(k) submission for a GIA™ Auto Suture™ Stapler with DST Series™ Technology, focusing on labeling changes. It explicitly states that no clinical study was deemed necessary because "substantial equivalence has been sufficiently demonstrated by non-clinical studies." This means the information requested about acceptance criteria, human readers, sample sizes for test and training sets, and ground truth establishment for a human-in-the-loop AI device is not applicable to this submission.
The testing performed was primarily for usability evaluation of labeling changes and a staple line reinforcement material evaluation (ex-vivo).
Therefore, I cannot provide the requested information.
§ 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.