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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 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 colectomy in patients with malignant strictures.

The WallFlex Duodenal Soft 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 Ntinol. The stent will be offered in two diameters, 22mm 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 consist of a coaxial tubing assembly that constrains the stent on the until the stent is released by retracting the exterior tube.

The WallFlex™ Colonic Soft Stem 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 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 diftate 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 the deployment limit marker band is located adjacent to the trailing end of the stent. The deployment limit marker band identifies the stent 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 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 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 pertains to a 510(k) premarket notification for a medical device, specifically the WallFlex Colonic and Duodenal Stent Systems. This document is a regulatory clearance letter from the FDA, asserting that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not describe the acceptance criteria and study proving a device meets those criteria for an AI/ML-enabled medical device. The product under review (WallFlex Stent Systems) is a physical, implantable medical device, not an AI/ML diagnostic or therapeutic system. Therefore, the concepts of "acceptance criteria for an AI/ML device," "test set sample size," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," "training set size," and "ground truth establishment for training" are not applicable to the content of this FDA clearance letter.

The letter focuses on demonstrating substantial equivalence to already cleared predicate devices based on:

• Intended Use/Indications for Use: The current devices have identical indications for use as their predicates, which are for palliative treatment of malignant colonic and duodenal strictures and large bowel obstructions.
• Technological Characteristics: The devices are stated to be identical to the predicates in terms of principles of operation, technical characteristics, performance, and materials (Nitinol stents with anchor lock delivery systems).
• Non-Clinical Tests: The documentation mentions compliance with FDA guidance for MR safety (ASTM F2503e2020), which is a standard non-clinical test for implantable devices, not an AI/ML algorithm validation.

In summary, this document is a 510(k) clearance for a conventional medical device and does not contain the information requested about acceptance criteria and study data for an AI/ML-enabled medical device.

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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:

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.

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