(74 days)
The WallFlex Colonic Soft 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 colectory in patients with malignant strictures.
The WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
The WallFlex™ Colonic Soft Stent System with Anchor Lock Delivery System and WallFlex™ Duodenal Soft Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the Anchor Lock Delivery System.
The stent is manufactured from Nitinol wires braided together to form a cylinder with a flared end. The wires are looped at both stent ends and welded at the non-flared end. The WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent will be offered in three diameters: 22 mm with a 27 mm flare, 20 mm with a 25 mm flare, and 18 mm with a 23 mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The stent sizes that are shared between the WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent are identical in all aspects of their design; the only difference is in indication.
The stent is compressed on a flexible catheter for delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during deployment. There are 3 radiopaque marker bands on the delivery system to facilitate placement; the exterior tube marker band, the deployment limit marker band, and the post deployment marker band. The exterior tube marker band is located adjacent to the leading end of the stent and the deployment limit marker band is located adjacent to the trailing end of the stent. The deployment limit marker band identifies the stent deployment limit, the point beyond which the stent cannot be reconstrained. The post deployment marker band, situated 4cm from the trailing end of the constrained stent, helps to facilitate accurate placement of the stent. The only design difference between the colonic and duodenal product offerings is how the stent is loaded onto the delivery system. The colonic stent is loaded with the flare is distal to the operator, and the duodenal stent is loaded with the flare is proximal to the operator.
The Anchor Lock stent holder is located at the trailing end of the stent and secures the stent on the delivery system to aid in reconstrainment when repositioning the stent. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in. / 0.89 mm guidewire. The device may be inserted through the working channel of a 9 French endoscope (minimum channel diameter 3.2mm scope). The WallFlex Colonic/Duodenal Soft Stent with Anchor Lock Delivery System will be offered in 230cm.
The provided text is a 510(k) premarket notification for a medical device. It does not describe or include a study that proves the device meets specific acceptance criteria in the manner of an AI/ML medical device.
The document describes the submission of a new stent system (WallFlex Colonic Soft Stent System with Anchor Lock Delivery System and WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System) and claims substantial equivalence to existing predicate devices (WallFlex Enteral Colonic/Duodenal Stent with Anchor Lock Delivery System).
The "Performance Data" section lists various bench tests conducted to establish this substantial equivalence. These are engineering-focused tests for physical properties and functionality, not clinical studies involving human or even observational data on device performance in patients or with human readers.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, ground truth establishment for training set).
The document explicitly states:
- "Performance testing (bench) was successfully completed to establish substantial equivalence between the proposed device and the predicate device." This confirms the tests were bench tests, not clinical studies.
- The tests listed are for physical characteristics: Trackability/Pushability, Marker Band Visualization, Deployment Force, Reinstrainment Force, Stent Reinstrainment Percentage, Withdrawal of Partially Deployed Stent, Deployment Accuracy, Bond Integrity, Unconstrained Stent Length, Unconstrained Stent Diameter, Flare Diameter, Stent Hoop Force (Expansion and Compression), Stent Fatigue Resistance, Stent Flexibility, Stent Corrosion Resistance, Endoscope Compatibility Device Outer Diameter, Potentiodynamic, Foreshortening, Comparative Hoop Force (Expansion and Compression).
In summary, there is no information in the provided text that aligns with the request for AI/ML device performance study details.
§ 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.”