(264 days)
The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
The Niti-S Colonic Comfort Stent is indicative 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 the implantable metallic stent and introducer system.
The stent is made of nitinol wire. It is a flexible, fine mesh tubular prosthesis that has several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm.
The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.
This document is a 510(k) summary for the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent. It primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data from bench testing. It does not describe a study involving human subjects or AI.
Here's an analysis of what is present and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
The document mentions that "The results of the bench testing show that the subject devices meet their specifications" for various tests. However, it does not provide a specific table outlining the acceptance criteria and the numerical results for each test. Instead, it lists the types of bench tests conducted:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet specifications for: | - Deployment Accuracy |
| - Deployment Force | - Expansion Force |
| - Compression Force | - Dimensional |
| - Tensile Strength | - Shipping |
| - Shelf-life | - Corrosion |
| - MR Compatibility | - Axial Force |
| - Trackability and Visualization | - Repositioning Force |
| - Radiopacity | All listed tests met specifications and demonstrate substantial equivalence. |
| Sterility | In accordance with ISO 11135:2014 & AAMI/ANSI/ISO 11607-1:2019, AAMI/ANSI/ISO 11607-2:2019 |
| Biocompatibility | Acceptable biocompatibility profile (evaluated for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, chronic toxicity, and implantation effects) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The document only refers to "bench testing."
- Data Provenance: Not specified. Bench testing is typically performed in a lab setting, so country of origin isn't directly relevant in the same way as clinical data. This is not a study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This document describes bench testing of a medical device (stent and introducer system), not an AI algorithm or a diagnostic tool requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As this is bench testing, there is no expert adjudication of image interpretations or clinical diagnoses.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is a 510(k) submission for a physical medical device (stent), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. The document states the tests "meet their specifications."
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
§ 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.”