(58 days)
The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Niti-S Biliary Slim M Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 7 radiopaque markers; 3 in each end 1 in the center. It has a diameter of 6 or 8 mm and the length ranges from 40 to 120mm.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Niti-S Biliary Slim M Stent." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials for novel devices. As such, the document does not describe acceptance criteria for an AI/algorithm-driven device or study details for such a device, but rather for a physical medical device (a stent).
Therefore, I cannot extract the information required by your prompt, which specifically asks for criteria and study details related to an AI/algorithm-driven device like:
- Acceptance criteria and device performance table: The document describes the device, its intended use, and compares its technical characteristics to predicate devices. It does not provide performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI/algorithm.
- Sample size and data provenance: There is no mention of a test set, training set, or data provenance from patient images, as this is not an AI/algorithm.
- Experts for ground truth and qualifications: Not applicable, as there's no ground truth establishment for an AI.
- Adjudication method: Not applicable.
- MRMC study and effect size: No AI assistance or human reader performance is discussed.
- Standalone performance: No algorithm is being evaluated.
- Type of ground truth: Not applicable.
- Training set sample size: Not applicable.
- Ground truth for training set: Not applicable.
Instead, the document focuses on:
- Bench Testing: Describing physical tests performed on the stent (e.g., Pitting Corrosion Potential, Dimensional Verification, Radial Compression Force) and the delivery system (e.g., Delivery, Deployment, Withdrawal).
- Biocompatibility Testing: Stating that the material is identical to a previously cleared predicate device.
- Electrical Safety and EMC/Software Verification and Validation: Stating "Not applicable" as the device contains no electrical components or software.
- Animal Testing / Clinical Data: Stating "Not applicable" as these were not deemed necessary to establish substantial equivalence for this device.
In summary, the provided text describes the regulatory clearance process for a physical medical device (a stent) under the 510(k) pathway, and therefore does not contain the information requested about acceptance criteria and studies for an AI/algorithm-driven device.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.