(75 days)
The Ethicon™ Circular Staplers have application throughout the alimentary tract for end, end-to-soside anastomoses.
The Ethicon™ Circular Staplers are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver 2 concentric rows of staples on the outside of the cut line. The Ethicon™ Circular Staplers are available in two device configurations: CDH and ECS and two shaft lengths; a standard 26 cm shaft and an XL 37 cm shaft. Each configuration is available in 4 endeffector sizes: 21 mm, 29 mm, 33 mm. These configurations function in the same manner - to compress tissue and to produce the same closed staple on tissue. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location.
This 510(k) summary describes a device modification, rather than a completely new device. Therefore, the "acceptance criteria" and "device performance" discussed here refer to the device's ability to maintain its previous performance after the modification, not to establish initial performance benchmarks.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design Requirements) | Reported Device Performance |
|---|---|
| Tissue cutting reliability | Maintained reliable tissue cutting (as demonstrated by testing) |
| Force-to-fire (test skin) | Maintained appropriate force-to-fire (as demonstrated by testing) |
| Device stapling performance | Maintained stapling performance (as demonstrated by testing) |
| Overall device function | Performed as intended after modification |
| Meeting design specifications | Met design specifications after modification |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the "ex-vivo (bench) testing" aspects (tissue cutting reliability, force-to-fire, stapling performance). It only mentions that testing was performed.
The data provenance is retrospective in the sense that the testing was performed on the modified device to verify that the changes did not negatively impact performance, essentially re-validating against existing design requirements. The data is from bench testing, meaning it was conducted in a laboratory setting, not in a clinical environment. No country of origin for the data is specified, but it can be inferred to be associated with the manufacturer, Ethicon Endo-Surgery, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was bench testing against design specifications, not a study requiring expert interpretation of results or establishing ground truth in a clinical or diagnostic context.
4. Adjudication Method for the Test Set
Not applicable. As this was bench testing, results likely involved objective measurements against predefined engineering specifications. There would be no need for adjudication by multiple human observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission form explicitly states: "This submission does not include data from Clinical Studies."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a mechanical surgical stapler. It does not involve any algorithms or AI that would require standalone performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" for this submission was the existing design requirements and specifications for the Ethicon™ Circular Staplers. The testing aimed to demonstrate that the modified device continued to perform to these established specifications.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this device is a mechanical stapler and does not involve machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for a mechanical device. The original design requirements and performance characteristics would have been established during the initial development and clearance processes for the predicate devices.
§ 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.