(50 days)
The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.
The Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent System provides an alternate method to deploy the Alveolus/Endoventions Esophageal stent. The implantable stent for the Alveolus/Endoventions ALIMAXX-E and the subject device are the same. The ALIMAXX-E DV delivery device provides a direct visualization (DV) of the stent deployment by providing a channel inside of the delivery device for a flexible endoscope. This channel allows the physician to directly visualize placement location, and deployment of the stent.
The provided text describes a medical device, the ALIMAXX-E DV Esophageal Stent System, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a performance study against a predefined standard.
Therefore, most of the requested information cannot be extracted from the given text.
Here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria or report performance metrics against such criteria. It states that "The 510(k) Notice contains summaries of physical test results for the delivery device as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)" and "The data presented demonstrate that the device is suitable for its indicated use." However, the actual results or explicit acceptance criteria are not included in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided. The document mentions "physical test results" but does not detail the sample size or the nature of the data (e.g., in-vitro, in-vivo, clinical, retrospective/prospective).
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):
- Cannot be provided. This type of information is not relevant to a 510(k) submission focused on mechanical device testing and substantial equivalence, and therefore is not present. "Ground truth" in the context of expert review is typically associated with diagnostic or AI performance studies, which this is not.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. Not applicable or mentioned.
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:
- Cannot be provided. This is a medical device (stent system), not an AI diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. As noted above, "ground truth" as typically defined for diagnostic or AI studies is not relevant here. The "proof" for this device's suitability comes from physical testing and comparison to predicate devices, not from clinical ground truth establishment in the diagnostic sense.
8. The sample size for the training set:
- Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set is mentioned.
§ 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.”