(26 days)
Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Niti-S Colonic Comfort Stent is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of an implantable metallic stent and an introducer system.
The stent is made of nitinol wire and is designed as a flexible, fine mesh tubular prosthesis with several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm, while the Niti-S Colonic Comfort Stent is available in diameters of 22 mm and 24 mm. Both stent types are available in lengths of 60 mm, 80 mm, 100 mm, and 120 mm.
The stent delivery system accommodates a 0.035 in (0.89 mm) guidewire. It is advanced over the guidewire and passed through an endoscope into the duodenum or colon. Fluoroscopy is recommended to ensure accurate device placement.
This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for medical devices. It primarily focuses on the substantial equivalence determination for the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent.
Crucially, this document does not describe studies involving AI or software-based medical devices with performance metrics like sensitivity, specificity, or AUC. It is for a physical medical device (stent and delivery system) and the performance testing mentioned are mechanical and material integrity tests.
Therefore, I cannot provide the information requested regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/software device. The questions about sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all irrelevant to the content of this document.
The "Performance Testing" section (page 7) lists the following non-clinical tests:
- Packaging strength and dye penetration
- Sterility verification
- Deployment accuracy test
- Deployment force test
- Dimensional test
- Tensile strength test (SDS)
- Trackability and visualization test
- Repositioning force test
These are standard engineering and material science tests for physical medical devices to ensure they function as intended and are safe. The document states that the results "demonstrate that the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent are as safe and effective as the predicate device and supports a determination of substantial equivalence."
In summary, the provided document does not contain the information requested about AI device performance studies.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”