(109 days)
The WallFlex Colonic Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.
The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
The WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the anchor lock delivery system.
The proposed stent is manufactured of Nitinol. The stent will be offered in two diameters, 22mm with a 27mm flare and 25mm with a 30mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The WallFlex Duodenal Stent will only be offered in the 22mm/27mm stent diameter (all lengths) preloaded on the 230cm Anchor Lock Delivery System. The WallFlex Colonic Stent will be offered in the 22mm/27mm and 25mm/30mm diameters (all lengths) preloaded on the 230cm or 135cm Anchor Lock Delivery System. The Anchor Lock delivery system consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.
There is no information regarding the acceptance criteria of an AI/ML device in the provided text. The document pertains to the 510(k) clearance of the WallFlex Colonic Stent System and WallFlex Duodenal Stent System, which are physical medical devices, not AI/ML software. Therefore, I cannot address aspects like sample size for test sets, data provenance, expert consensus, MRMC studies, or training set details as these are not relevant to the described device and its clearance process.
The document focuses on the substantial equivalence of the proposed WallFlex stent systems to their predicate devices, with the only change being to the surface finish of the nitinol wire. Performance data provided is for bench testing of the physical stent system, not for an AI/ML algorithm.
Here's what can be extracted from the provided text regarding device performance:
1. A table of acceptance criteria and the reported device performance:
| Section | Test | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|
| 18.1 | Deployment Force | Met pre-defined product specifications | Pass |
| 18.2 | Reconstrainment Force | Met pre-defined product specifications | Pass |
| 18.3 | Unconstrained Stent Length | Met pre-defined product specifications | Pass |
| 18.4 | Unconstrained Stent Diameter | Met pre-defined product specifications | Pass |
| 18.5 | Flare Diameter | Met pre-defined product specifications | Pass |
| 18.6 | Stent Hoop Force (Compression and Expansion) | Met pre-defined product specifications | Pass |
| 18.7 | Stent Fatigue Resistance | Met pre-defined product specifications | Pass |
| 18.8 | Stent Flexibility | Met pre-defined product specifications | Pass |
| 18.9 | Stent Corrosion Resistance | Met pre-defined product specifications | Pass |
| - | Potentiodynamic testing | Met recent FDA guidance | Passing |
| - | Foreshortening | Met recent FDA guidance | Passing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for these bench tests.
- The data provenance is not mentioned, but it is implied to be laboratory testing of the physical device components.
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. Ground truth for these engineering performance tests would be based on predefined specifications and measurement standards, not expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The tests are bench tests with objective outcomes (pass/fail against engineering specifications). Reconciliation or adjudication methods are not typically used for this type of testing.
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 device is a physical stent system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for these tests would be internal engineering specifications and relevant industry standards for stent performance, which are not detailed in this summary but are demonstrably met for the device to "Pass."
8. The sample size for the training set:
- Not applicable. There is no training set for a physical device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for a physical 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.”