(10 days)
The DST Series ™ EEA™ OrVil™ 21 mm device when used with the DST Series™ EEA™ 21 mm stapler, the DST Series ™ EEA™ OrViJ™ 25 mm device when used with the DST Series™ EEA™ 25mm stapler, and the DST Series ™ EEA™ OrVil™ 28 mm device when used with the DST Series ™EEA™ 28 mm stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
The DST Series™ EEA™ 21, 25 or 28 mm stapler, creates a circular, double staggered row of titanium staples. Immediately after staple formation, the stapler knife blade resects the excess tissue, creating a circular anastomosis. The DST Series™ EEA Surgical Stapler comes with a detachable anvil. As an accessory to this instrument we have modified the detachable anvil assembly to create the DST Series OrVil™. The anvil assembly is mounted on a delivery tube and is secured to the tube. A retraction suture is also tied to the anvil assembly.
The provided text is a 510(k) summary for a medical device (DST Series™ EEA™ OrVil™ Stapler Anvil Accessory) and does not contain the specific information requested in the prompt about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for an AI medical device.
The document describes a mechanical stapler accessory and its intended use, technological characteristics, and conformance to biological evaluation standards. It mentions "in-vitro and in-vivo tests were performed to verify that the performance of the DST Series™ EEA™ OrVil™ Device is substantially equivalent to the predicate devices, and to validate that DST Series™ EEA™ OrVil™ Device will perform as intended." However, it does not provide any details about these tests, their results, or acceptance criteria in the format requested for an AI/ML device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input document does not contain this information for 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.