(21 days)
The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in patients with strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.
The Endoventions Esophageal Stent Technology System is comprised of two components: the stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter near the distal and proximal ends to minimize the possibility of the possible only near the distar and proximal strace to maintain a constant length over the entire overall stent geometry lo doclynbu to this unique design the stent has range of possible diamelers. The a facilitating the selection of the appropriate stent length.
The provided document is a 510(k) summary for the Endoventions ALIMAXX-E™ Esophageal Stent System. This document describes a medical device and its substantial equivalence to previously cleared devices. It does not contain information about studies proving the device meets acceptance criteria in the way typically expected for AI/ML device evaluations (i.e., performance metrics, sample sizes, expert ground truth, etc.).
Instead, the document focuses on:
- Device Description: The physical characteristics of the esophageal stent and its delivery system.
- Intended Use (Indications): Maintaining esophageal patency in malignant strictures and occlusion of esophageal fistulae.
- Substantial Equivalence: Comparing the device to existing predicate devices (Boston Scientific Ultraflex™ and Rusch International Polyflex Stents).
- Testing for Substantial Equivalence: Mentions "summaries of physical test results, and mechanical test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)." This refers to engineering/mechanical testing, not clinical performance studies with human readers or AI.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving those criteria are met because such a study (as you've defined it for AI/ML devices) is not present in this 510(k) summary. The FDA's 510(k) pathway for traditional medical devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing, biocompatibility testing, and sometimes limited clinical data, rather than extensive performance studies with specified acceptance criteria for algorithm performance, reader improvement, or stand-alone accuracy against expert ground truth.
Disclaimer: This response is based solely on the provided text. If a detailed performance study with acceptance criteria, human reader comparisons, or AI performance metrics exists for this device, it is not included in the provided 510(k) summary.
§ 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.”