(45 days)
The ECHELON families of endoscopic linear cutters are intended for transection, resection, 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, White, is a thin 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 will provide a closed staple height of 1.0 mm for use in thin tissue such as mesentery and pulmonary and renal artery and vessels.
The provided text is a 510(k) Summary for a medical device (Echelon Endoscopic Linear Cutter Reload, White). It describes the device, its intended use, and its technological characteristics. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a specific study proving device performance. This document is a regulatory submission for substantial equivalence, not a full clinical study report.
Here's what can be extracted from the provided text and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Bench and Animal testing performed to demonstrate that device updates do not affect safety and effectiveness and that the device will perform as intended. |
| Performance as Intended | Bench and Animal testing performed to demonstrate that device updates do not affect safety and effectiveness and that the device will perform as intended. |
| Closed Staple Height for Thin Tissue (Mesentery, Pulmonary & Renal Artery/Vessels) | Provides a closed staple height of 1.0 mm. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The document mentions "Bench and Animal testing" but does not give sample sizes for either.
- Data Provenance: Not specified. The document states the testing was performed, but not where or whether it was retrospective or 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)
- Not applicable as this is a mechanical device requiring performance testing, not diagnostic image interpretation. Ground truth for mechanical performance typically comes from calibrated measurements and established engineering standards, not expert consensus in the human interpretation sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, often in diagnostic AI. This device's performance is assessed through bench and animal testing, which relies on objective measurements.
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
- No. This is a surgical stapling device, not an AI-powered diagnostic tool. MRMC studies and AI assistance comparisons are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical device, not a software algorithm. Its performance is inherent to its design and mechanical function, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "Bench and Animal testing," the ground truth would typically be established by objective measurements and observations according to pre-defined protocols and engineering specifications. For animal testing, this would include observation of tissue healing, staple line integrity, and adverse events, which could be considered a form of outcomes data and pathological observation if tissue samples were analyzed. However, the document does not specify these details.
8. The sample size for the training set
- Not applicable. This is a medical device, not a machine learning model that uses a "training set." The development process involves engineering design, prototyping, and iterative testing, not AI model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this 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.