(270 days)
The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, thoracic and urologic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.
The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload.
This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.
The provided text describes a 510(k) premarket notification for the AEON™ Endoscopic Stapler. The submission aims to revise the labeling of the existing device, specifically expanding its indications for use.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria for the AEON™ Endoscopic Stapler in the context of expanding its indications. Instead, the performance data section focuses on "safety and effectiveness" as the overarching goal for the revised labeling.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety for use in liver, spleen, and pancreas | No complications associated with the AEON™ Endoscopic Stapler in these organs. |
| Effectiveness for use in liver, spleen, and pancreas | No complications associated with the AEON™ Endoscopic Stapler in these organs. |
| Substantial equivalence to predicate device | The proposed device is demonstrated to be as safe and as effective as the predicate device based on performance testing, intended use, and technological characteristics. The only difference is modified labeling. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify an exact numerical sample size for the retrospective clinical studies. It vaguely refers to "the results of the retrospective clinical studies."
- Data Provenance: The studies are described as "retrospective clinical studies." There is no mention of the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information about the number or qualifications of experts used to establish ground truth for the retrospective clinical studies.
4. Adjudication method for the test set:
The document does not mention any adjudication method for the retrospective clinical studies.
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 applicable as the device is a mechanical stapler, not an AI-assisted diagnostic tool or an imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a mechanical stapler.
7. The type of ground truth used:
For the retrospective clinical studies, the ground truth appears to be outcomes data in terms of observed complications or lack thereof during real-world surgical use. The statement "no complications associated with the AEON™ Endoscopic Stapler" suggests that the absence of adverse events served as the evidence for safety and effectiveness in the expanded indications.
8. The sample size for the training set:
This is not applicable as a training set is typically associated with machine learning or AI models. The studies described are retrospective clinical studies of a mechanical device.
9. How the ground truth for the training set was established:
This is not applicable for the reasons mentioned in 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.