(299 days)
The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.
The Ultraflex™ Diamond Biliary Stent System is a biliary stent system. It is a self-expanding stent made of Nitinol, constructed using a monofilament, twisted method. It has an overall OD of 10 mm and overall lengths of 40-80 mm. The delivery system has a sliding sheath design, a usable length of 194 cm, a shaft OD of 2.7 mm - 3.02 mm, and is compatible with a 0.035" guidewire.
The provided text describes a 510(k) summary for the Ultraflex™ Diamond Biliary Stent System, focusing on its substantial equivalence to a predicate device. This type of submission relies on comparing the new device to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as you might see for novel technologies or higher-risk devices.
Therefore, the information you're requesting regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for performance evaluation is not present in this document. The submission focuses on performance characteristics verified through laboratory testing and biocompatibility assessments, and equivalence based on design and materials.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a formal table of acceptance criteria for specific performance metrics (like sensitivity, specificity, or reader agreement) and corresponding reported device performance values as would be typical for an AI/CADe device. Instead, the "acceptance criteria" are implied by the substantial equivalence determination, meaning the device must be as safe and effective as the predicate device.
The document states: "Laboratory testing regarding characteristics was performed on Ultraflex™ Diamond Biliary Stem System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Ultraflex™ Diamond Biliary Stent System with satisfactory results."
The "performance" described is about the physical characteristics of the stent and delivery system compared to the predicate, as shown in Table 10-1.
| Characteristic | Ultraflex™ Diamond Biliary Stent System (This 510(k)) | Schneider Wallstent® Endoscopic Biliary Endoprosthesis (Predicate) | Result/Comparison |
|---|---|---|---|
| Indications for Use | Malignant Biliary Strictures | Malignant Biliary Strictures | Same |
| Route of Administration | Endoscopic | Endoscopic | Same |
| Stent Overall OD | 10 mm | 8 - 12 mm | Within predicate range |
| Stent Overall Length | 40 - 80 mm | 40 - 80 mm | Same |
| Stent Material | Nitinol | Stainless Steel | Difference (justified by lab testing) |
| Stent Construction Method | Monofilament, Twisted | Monofilament, Braided | Difference (justified by lab testing) |
| Stent Expansion Mode | Self-Expanding | Self-Expanding | Same |
| RO Marker Location | Stent and Delivery System | Delivery System | Difference (design variation) |
| Delivery System Design | Sliding Sheath | Sliding Sheath | Same |
| Delivery System Usable Length | 194 cm | 195 cm | Very similar |
| Delivery System Shaft OD | 2.7 mm - 3.02 mm | 2.5 mm | Similar/Slight variation |
| Delivery System Compatible Guidewire | 0.035" | 0.035" - 0.038" | Similar/Within predicate range |
The "acceptance criteria" here are that the Ultraflex™ Diamond Biliary Stent System's characteristics and performance verified through in-vitro laboratory testing and biocompatibility assessment demonstrate that it is as safe and effective as the predicate device. The slight differences in material, construction, RO marker location, usable length, and shaft OD were deemed acceptable based on the provided laboratory testing and the overall conclusion of substantial equivalence.
The following information is NOT available in the provided text, as it describes a 510(k) submission for a medical device (stent), not an AI/CADe product. Therefore, no studies of the type you describe were conducted or reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set data is provided. Performance verification was based on in-vitro lab testing and biocompatibility.
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. No clinical test set data requiring expert ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set data requiring adjudication is provided.
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
- Not applicable. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this medical device submission relies on established engineering principles, material science testing standards, and biocompatibility guidelines.
8. The sample size for the training set
- Not applicable. This is not an AI/CADe device, and no training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
§ 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.