(26 days)
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastoments have application in multiple open or minimally invasive general, gynecologic, urologic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ECHELON FLEX Powered Plus Compact Articulating Endoscopic Linear Cutter is a sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 60 Powered Plus instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
The provided text is a 510(k) summary for a medical device (Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter) and a clearance letter from the FDA. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and performance testing to ensure safety and effectiveness.
However, the document does not contain the kind of detailed information about acceptance criteria, specific study designs, sample sizes for test/training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies that you are asking for. It states that "Ex-vivo tests (bench) were performed to ensure that the devices performed as intended and met design specifications" and that "Risk analyses and design verification testing was also conducted for the changes described in this submission to ensure that the performance of the device was not affected by the device modifications."
The performance data section lists the types of verification testing done (e.g., staple line integrity, force to fire, reliability testing, articulation angle, ergonomic weight, bailout system tests) but does not provide:
- A table of acceptance criteria and reported device performance: It generally states that the device "met design specifications" and "performed as intended" without numerical values or specific thresholds.
- Sample sizes used for the test set and data provenance: No sample sizes are given for the ex-vivo bench tests. The data provenance is "ex-vivo tests (bench)" rather than clinical data from a country/region.
- Number of experts and their qualifications for ground truth: Not applicable, as the testing described is bench testing, not image analysis requiring expert ground truth.
- Adjudication method for the test set: Not applicable for bench testing.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted. The study described is bench testing of the device itself, not a study of human readers using AI.
- Standalone (algorithm only) performance: Not applicable, as this is a surgical stapler/cutter, not an AI algorithm.
- Type of ground truth used: For bench tests, the "ground truth" would be the expected physical or mechanical properties and their measurement against specified ranges, but this is not detailed.
- Sample size for the training set: Not applicable, as there's no mention of an algorithm or machine learning training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a regulatory submission for a physical medical device (surgical stapler) based on bench testing to demonstrate substantial equivalence to a predicate device. It does not involve AI, image analysis, or clinical trials with human readers or expert ground truth in the way your questions imply.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.