(393 days)
The Memotherm colorectal stent is indicated for the palliative treatment of colonic strictures and obstruction caused by malignant neoplasms in the rectum, sigmoid colon and descending colon.
The Memotherm® Colorectal Stent comprised of two components - a self-expanding implantable metal stent and the delivery device. The stent is a nitinol grid-like cylinder with flared ends, available in 20 and 30mm diameters and 60, 80, and 100mm lengths. While mounted on the deployment system the stent is compressed. Upon release of the stent from the deployment system the nitinol cylinder expands. The coaxial deployment system consists of an inner catheter, an outer sheath and an ergonomically shaped handgrip. Female luer injection ports are included on the back of the handgrip and ratchet carriage. Two radiopaque markers are positioned on the deployment system to mark both ends of the stent.
The provided text describes the Memotherm® Colorectal Stent and details its submission for 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, or information related to AI/algorithm performance. It primarily focuses on demonstrating substantial equivalence to a predicate device through general comparative testing and literature review.
Here's an analysis of the provided information relative to your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated but Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: | |
| - Trackability (ability to be navigated to target site) | Within anticipated results |
| - Deployment (successful release of stent) | Within anticipated results |
| - Stent Expansion/Compression | Within anticipated results |
| - Tensile and Dimensional Verifications | Within anticipated results |
| - Corrosion Resistance (within anatomical environment) | Resistant |
| Safety and Effectiveness (Inferred from Predicate): | |
| - Palliative treatment of colonic strictures/obstruction | Demonstrated through relevant published literature for self-expanding metal stents in the colon. |
2. Sample size used for the test set and the data provenance
The document mentions "Comparative performance testing was done, where appropriate, between the Memotherm and WALLSTENT." However, it does not specify:
- The exact sample size for this comparative testing.
- The data provenance (e.g., country of origin, retrospective/prospective). It seems to refer to bench testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document relies on "relevant published, scientific, literature" for the general effectiveness of metal stents, and internal bench testing for comparative performance. There is no mention of expert-established ground truth for a test set in the context of a diagnostic or AI-assisted device.
4. Adjudication method for the test set
This information is not provided. Given the nature of the testing described (bench tests and literature review), adjudication methods for diagnostic performance are not relevant or 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
There is no mention of an MRMC study. This device is a physical medical device (stent), not an AI diagnostic or assistance system. Therefore, AI-related performance metrics and human reader improvement are not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical stent, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the effectiveness claim, the ground truth appears to be derived from:
- "relevant published, scientific, literature" demonstrating the effectiveness of self-expanding metal stents for palliative treatment of colon cancers.
- The established performance of the predicate device (WALLSTENT® Enteral Endoprosthesis).
For the performance testing (tensile, dimensional, trackability, deployment, expansion/compression), the ground truth would be the expected engineering specifications and functional outcomes.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
§ 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.”