(34 days)
The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection.
It may be used for transection of liver substance, hepatic vasculature and biliary structures.
The Endo GIA™ Radial Reload with Tri-Staple™ Technology is a curved stapler cartridge that places three staggered rows of staples on either side of a cut line and simultaneouly divides (cuts) the tissue between the rows.
Covidien Reloads with Tri-Staple™ Technology apply height progressive rows of titanium staples on either side of the cut line. The shortest staple length is located in the first staggered row nearest the knife, an intermediate staple length is located in the second row, and the longest staple length is located in the third (outside) staggered row.
The Endo GIA™ Radial Reload with Tri-Staple™ Technology is compatible with the Endo GIA™ ULTRA Universal Stapler and GIA™ and Endo GIA™ Universal Stapler handles, and incorporates the functionality of those handles including interlocks to prevent firing a previously fired cartridge.
The provided text describes a medical device, the "Covidien Endo GIA™ Radial Reload with Tri-Staple™ Technology," which is a surgical stapler cartridge. The document is a 510(k) summary for premarket notification, indicating its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to independently establish de novo acceptance criteria with a comprehensive study design as one might find for a novel diagnostic AI algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set details) are not applicable in this context, as they relate to the validation of AI/machine learning diagnostic devices or studies involving human interpretation. This document describes a surgical stapling device, which is validated through bench and animal performance evaluations.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available or not relevant to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in a table format that would typically be associated with AI/diagnostic device performance (e.g., specific sensitivity, specificity, or F1-score targets). Instead, the performance evaluations verify that the device is "safe and effective and performs as intended" through various bench and in vivo tests. The "reported device performance" is a general statement that these tests were "completed to verify" the safety and effectiveness.
| Performance Evaluation Category | Stated Purpose/Verification | Outcome |
|---|---|---|
| Bench Tests: | ||
| In vitro staple formation | Verify safe and effective performance | Completed to verify |
| Firing force | Verify safe and effective performance | Completed to verify |
| Staple line pull-apart force | Verify safe and effective performance | Completed to verify |
| Animal Model Tests: | ||
| In vivo staple formation | Verify safe and effective performance | Completed to verify |
| Free bleed | Verify safe and effective performance | Completed to verify |
| Burst strength | Verify safe and effective performance | Completed to verify |
| Air leak | Verify safe and effective performance | Completed to verify |
| Tissue grasping | Verify safe and effective performance | Completed to verify |
| Trauma | Verify safe and effective performance | Completed to verify |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "Bench and animal model performance evaluations were completed," but does not provide the number of samples, animals, or tests performed for each category.
- Data Provenance: The studies were conducted as "Bench and animal model performance evaluations." The country of origin is not specified, but the submission is to the U.S. FDA. The studies are prospective in the sense that they were designed tests rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a surgical stapling device, not a diagnostic device requiring expert interpretation for "ground truth" establishment in a test set. The performance evaluations involved physical and biological tests.
4. Adjudication method for the test set
- Not Applicable. See point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, which is not relevant to the physical and biological performance testing of a stapling device.
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
- Not Applicable. This is not an AI-assisted diagnostic device. No human reader studies (MRMC) were conducted or are relevant to demonstrate the safety and effectiveness of a surgical stapler.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical surgical stapler, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used
- Inferred Ground Truth: For the performance evaluations, the "ground truth" would be the direct measurement of physical properties (e.g., staple formation, firing force, pull-apart force, burst strength, air leak) and direct observation of biological outcomes (e.g., free bleed, tissue grasping, trauma) in controlled bench and animal models. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/diagnostic device validation but rather objective measurement against predefined engineering and biological success criteria, though these criteria themselves are not explicitly detailed in the provided text beyond the general statement of "safe and effective."
8. The sample size for the training set
- Not Applicable. This is not a machine learning device. The concept of a "training set" does not apply. Design and development of the stapler would involve iterative testing and refinement, but not in the sense of a machine learning training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.