(59 days)
The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.
The proposed WallFlex™ Enteral Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is two components: an insplantaoffered in two diameters: 25mm body with a 30mm flare, mandracetal or over with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the WallFlex™ Enteral Colonic Stent:
It's important to note that the provided document is a 510(k) summary for a premarket notification, not a full clinical study report. Therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The "performance data" mentioned here refers to engineering and bench testing, not clinical studies in humans.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical/Physical Equivalence | |
| Dimensional Evaluation | Performance/results are comparable to predicate devices. |
| Fatigue Testing | Performance/results are comparable to predicate devices. |
| Radial Force Comparison | Performance/results are comparable to predicate devices. |
| Deployment and Reconstrainment Force | Performance/results are comparable to predicate devices. |
| Bond Integrity | Performance/results are comparable to predicate devices. |
| Material/Safety Compatibility | |
| MRI Compatibility | Performance/results are comparable to predicate devices. |
| Overall Conclusion | "WallFlex Enteral Colonic Stent with Anchor Lock Delivery system is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic Stent and the Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System." |
Note: The document does not provide specific numerical acceptance criteria (e.g., "radial force must be > X Newtons") or detailed numerical results for the WallFlex™ stent. Instead, it states that the performance for these categories was compared and found to be substantially equivalent to predicate devices.
Study Details
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Sample size used for the test set and the data provenance:
This document describes bench testing (mechanical, physical, and material compatibility tests), not a clinical test set involving human patients. Therefore, terms like "sample size for the test set" (in a clinical sense) and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable here. The tests were likely conducted in a laboratory setting, and the "samples" would be individual stents/delivery systems. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth, in the clinical sense, refers to confirmed diagnoses or outcomes. The "ground truth" for the engineering performance tests would be the established engineering standards or the performance of the predicate devices, against which the new device's performance was compared. This would be evaluated by engineers or scientists performing the tests. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it pertains to clinical data interpretation or consensus. Bench testing results are typically quantifiable and do not require expert adjudication in the same manner. -
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:
This is not applicable. MRMC studies are for evaluating diagnostic tools, often involving AI, and human reader performance. This document concerns a medical device (a stent) and its mechanical/physical equivalence, not an AI-powered diagnostic. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This document describes a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the engineering performance tests, the "ground truth" was the established performance characteristics of the predicate devices and/or relevant engineering standards. The goal was to demonstrate that the WallFlex™ stent performed similarly or met the same benchmarks as the already approved predicate devices. -
The sample size for the training set:
This is not applicable. There is no "training set" in the context of this device's engineering performance testing. This concept applies to machine learning algorithms. -
How the ground truth for the training set was established:
This is not applicable for the same reason as above.
Summary of what the document does provide:
- Type of Study: Comparative performance testing (bench testing) and comparison to predicate devices, not clinical trials.
- Purpose: To establish substantial equivalence of the WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System to two named predicate devices (Ultraflex™ Precision™ Colonic Stent System, K030769 and Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System, K000281) for 510(k) clearance.
- Evaluated Characteristics: Dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity, and MRI compatibility.
- Conclusion: The device was found to be substantially equivalent based on these comparative tests.
§ 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.”