(25 days)
The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges has application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses and can be used with staple line or tissue buttressing materials.
The Ethicon Endo-Surgery Linear Cutter is a sterile, single patient use instrument used in open surgical procedures. The instrument delivers six staggered rows of staples, three on either side of the cut line. The instrument is shipped without a cartridge loaded into the instrument. The cartridge must be loaded as a separate step prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired. Each Ethicon Endo-Surgery Selectable Cartridge contains six staggered rows of staples and an integrated knife located in the safety housing. The selectable staple height feature provides the ability to use one cartridge for compressed tissue with thicknesses of 1.5mm, 1.8mm or 2.0mm. The staple retaining cap on the cartridge protects the staples during shipping and transportation.
The provided text describes the Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges, including its indications for use, technological characteristics, and a brief mention of performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Specifically, the document states:
"Performance Data Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the new devices will perform as intended."
This is a very high-level statement and does not provide the granular details required for your table or the specific sections of your request.
Therefore, I can only provide a partial answer based on the available information.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the new devices will perform as intended." |
Explanation: The document does not explicitly state specific acceptance criteria (e.g., minimum staple retention force, burst pressure, or specific success rates). It only broadly mentions that testing was done to ensure the device "perform[s] as intended."
2. Sample size 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.
- Data provenance: "preclinical laboratory evaluation in an animal model" - This implies prospective data collection, but the country of origin is not mentioned.
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):
- This information is not provided. The study mentioned is a "preclinical laboratory evaluation in an animal model," which typically involves researchers and veterinarians, but their number and qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided.
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:
- This is not a software device that involves "readers" or "AI." It is a surgical stapling device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not a software algorithm; it is a physical surgical device. Therefore, a standalone algorithm-only performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given it was "preclinical laboratory evaluation in an animal model," the ground truth would likely be based on direct observations, measurements (e.g., staple line integrity, tissue integrity, healing), and potentially histology/pathology of the animal tissue, but this is not explicitly detailed.
8. The sample size for the training set:
- This is not a machine learning/AI device, so there is no "training set" in the conventional sense. The "bench testing" and "animal model" are for validation and verification of the device's mechanical and biological performance.
9. How the ground truth for the training set was established:
- As above, there is no "training set."
In summary, the provided document focuses on the regulatory submission (510(k) Summary) and clearance of a surgical stapler. While it confirms performance testing was conducted, it lacks the detailed scientific study parameters and results typically found in a dedicated research paper or detailed technical report.
§ 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.