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510(k) Data Aggregation
(99 days)
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
The proposed device is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula
The proposed WallFlex™ Partially Covered Esophageal Stent System consists of a selfexpanding metal stent and a delivery system. The proposed stent is manufactured of Nitinol and offered with a partial silicone covering. The stent configurations include two diameters, a 18mm body diameter with a 23mm flare, and a 23mm body diameter with a 28mm flare and three lengths. The 18mm body diameter stent is offered in 103mm, 123mm, and 153mm stent lengths. The 23mm body diameter stent is offered in 105mm, 125mm, and 155mm stent lengths. The proposed delivery system consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released.
The provided text describes a 510(k) premarket notification for the "WallFlex™ Partially Covered Esophageal Stent System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria, and thus the structure of the prompt is not fully applicable.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative performance metrics are provided in the document. The submission states that "Comparative performance testing was performed to establish substantial equivalence between the proposed WallFlex™ Partially Covered Esophageal Stent System, and the predicate devices." This testing included, but was not limited to:
- Dimensional evaluation
- Radial expansion force
- Radial compression force
- Deployment and reconstrainment force
- Bond integrity
Since this is a 510(k) submission, the "acceptance criteria" for these tests would typically be that the device performs equivalently to the predicate devices or within established design specifications. However, the exact thresholds or comparative results are not detailed in this summary.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalent dimensional properties to predicate devices. | Comparative testing performed. |
| Equivalent radial expansion force to predicate devices. | Comparative testing performed. |
| Equivalent radial compression force to predicate devices. | Comparative testing performed. |
| Equivalent deployment and reconstrainment force to predicate devices. | Comparative testing performed. |
| Equivalent bond integrity to predicate devices. | Comparative testing performed. |
Note: The document only states that comparative testing was performed, but does not provide the specific results or numerical acceptance thresholds for these tests.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the comparative performance testing. It also does not mention data provenance in terms of country of origin or whether the data was retrospective or prospective, as the testing described appears to be bench testing or in-vitro performance evaluation rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The performance data discussed relates to physical device characteristics and engineering tests, not clinical evaluations requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (esophageal stent) and focuses on engineering and performance characteristics compared to predicate devices, not on the interpretation of medical images by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical stent and delivery system, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing would be the established engineering specifications and the performance characteristics of the predicate devices. For example, for "dimensional evaluation," the ground truth would be the design specifications and the dimensions of the predicate devices. For "force" tests, the ground truth would be the expected force ranges or the force measurements of the predicate devices. This type of "ground truth" is not established by experts in the clinical sense, but by engineering design and testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and no "training set" in that context is mentioned or implied.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm mentioned.
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