(300 days)
The Schneider WALLSTENT® Enteral Endoprosthesis is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms.
The WALLSTENT® Enteral Endoprosthesis is comprised of two components: the implantable metallic stent and the delivery device. The stent is composed of implantgrade cobalt-base superalloy wire braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, and self-expanding. The stent is available in multiple sizes. Physician preference and individual patient condition and/or anatomy will determine the appropriate size chosen.
The provided 510(k) summary for the WALLSTENT® Enteral Endoprosthesis (K954290) does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the traditional sense of a clinical trial with performance metrics like sensitivity and specificity. Instead, the submission relies on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding performance results for the new device. The "performance" is primarily established through equivalence to predicate devices and general clinical success of the therapy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength (Fatigue & Radial Force): Demonstrates durability and ability to maintain lumen diameter. | "Results were all within the expected ranges" (for predicate devices). "WALLSTENT® Enteral Endoprosthesis introduces no new materials, design or processes of these tests were not repeated." |
| Material & Construction Equivalence: Identical materials, construction, and processing to predicate devices. | "The WALLSTENT® Enteral Endoprosthesis has identical technological (materials, construction, processing) characteristics as the predicate devices." |
| Clinical Efficacy (Palliative treatment of colonic strictures): Successful opening of bowel obstruction. | "A search of clinical literature has found that the clinical in vivo experience of a stent within the clinical indication that we are requesting has been successful." (Referring to metal stents in general). |
| Safety: Safe for its intended use. | "The results of these tests demonstrate that the Schneider WALLSTENT® Enteral Endoprosthesis is equivalent to the predicate device and is therefore safe for its intended use." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There was no specific clinical "test set" for the WALLSTENT® Enteral Endoprosthesis described beyond the existing literature on similar stents.
- Data Provenance: The reliance is on "clinical literature" and "clinical in vivo experience" of similar devices, suggesting a review of existing data rather than new prospective studies for this specific device. The country of origin and whether it was retrospective or prospective for this literature search are not specified.
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. There was no specific "test set" with ground truth established by experts for the WALLSTENT® Enteral Endoprosthesis in the information provided. The "ground truth" for efficacy is inferred from the successful clinical application of similar devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There was no specific test set or adjudication process described.
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 not an AI-assisted diagnostic tool, but rather a medical implant. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an implantable medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for the efficacy claim (opening bowel obstruction) is implied to be outcomes data from the "clinical in vivo experience of a stent," demonstrating successful relief of abdominal distention and discomfort. For mechanical properties, the ground truth would be established engineering standards or expected performance ranges.
8. The sample size for the training set:
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable.
§ 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.”