(133 days)
The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The Echelon Endoscopic Linear Cutter Reload, Black, is a thick tissue reload for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Powered Flex) in a 60mm configuration. It is part of the current Echelon reload family and provides a closed staple height of 2.3 mm for use in thick tissue such as gastric, lung, and solid organ.
The Echelon Endoscopic Linear Cutter Reload, Black is loaded into an Echelon Endoscopic Linear Cutter and delivers staples into the tissue when the instrument is fired.
Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Echelon Endoscopic Linear Cutter Reload, Black:
It is important to note that the provided text is a 510(k) submission document, which primarily focuses on demonstrating substantial equivalence to a predicate device. As such, the level of detail regarding specific performance studies and their statistical analysis might be different from a peer-reviewed research paper.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device performs as intended. | "Ex-vivo (bench) testing was performed to ensure that the devices perform as intended and meet design specifications." |
| Design Specifications | Meets established design specifications. | "Device performance was assessed against the design requirements and included process verification and design verification." |
| Substantial Equivalence | Equivalent to predicate device in terms of intended use, technological characteristics, and performance testing. | "The Subject device... is substantially equivalent to the legally marketed Predicate device based on intended use, technological characteristics, and performance testing." |
| Staple Line Integrity | Delivers staples with a closed height of 2.3 mm for thick tissue. | "provides a closed staple height of 2.3 mm for use in thick tissue such as gastric, lung, and solid organ." (This is a design feature, implicitly an acceptance criterion for performance.) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Ex-vivo (bench) testing was performed..." and "Device performance was assessed against the design requirements and included process verification and design verification."
- Sample Size for Test Set: Not explicitly stated in the provided text. The term "ex-vivo (bench) testing" implies a laboratory setting, but the number of devices or tests performed is not quantified.
- Data Provenance: The testing was "ex-vivo (bench) testing." This implies a laboratory, non-clinical setting, likely at the company's facilities. It is prospective testing designed to evaluate the new device. The country of origin of the data is not specified, but the company is based in the U.S. (Guaynabo, PR and Cincinnati, OH).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a bench test of a mechanical device like a stapler reload, "experts" in the traditional sense of medical image interpretation or clinical diagnosis would not be establishing ground truth. The "ground truth" would be objective measurements of mechanical performance (e.g., staple height, staple formation, burst pressure if applicable to the design specification, etc.) against pre-defined engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of this type of "ex-vivo (bench) testing" for a mechanical device. Adjudication typically refers to resolving discrepancies between multiple human evaluators, which is not relevant here. The evaluation of bench test results would be against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted (or at least not reported in this document). An MRMC study is typically used for diagnostic devices (e.g., imaging AI) where multiple human readers interpret cases with and without AI assistance. This document describes a mechanical surgical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A / No explicit algorithm involved. This device is a mechanical surgical stapler reload, not an AI or algorithmic device. Its performance is evaluated mechanically, not by an algorithm.
7. The Type of Ground Truth Used
The ground truth for the "ex-vivo (bench) testing" would be:
- Engineering Design Specifications: Pre-defined quantitative and qualitative requirements for the device's mechanical performance (e.g., staple height of 2.3mm, proper staple formation, firing mechanism integrity, tissue transection capabilities within specified limits).
- Predicate Device Performance Baseline: The performance of the legally marketed predicate device (K112056) would serve as a benchmark for comparison to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided as there is no "training set" for this type of mechanical device.
§ 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.