(15 days)
The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).
The AccuMesh Positioning System is laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.
The provided text describes a 510(k) submission for the AccuMesh Positioning System. The submission is for a component color change and asserts substantial equivalence to previously cleared devices. Therefore, the study details are minimal and do not contain information typically found in a comparative effectiveness study for a new AI/medical device.
Here's the breakdown of the information requested based only on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual inspection after aging | "all testing passed" |
| Opening | Passed |
| Closing | Passed |
| Articulating | Passed |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "Performance testing was performed on the colorant and consisted of opening, closing and articulating with visual inspection following aging at all hinge joints". It does not detail how many units were tested.
- Data Provenance: Not specified. The testing was performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The approval is for a color change, and the performance testing involved mechanical actions (opening, closing, articulating) with visual inspection, not clinical outcomes requiring expert assessment.
4. Adjudication method for the test set
Not applicable. The approval is for a color change, and the performance testing involved mechanical actions (opening, closing, articulating) with visual inspection, not clinical outcomes requiring adjudication.
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 document does notdescribe an MRMC study or any study involving human readers or AI assistance. The submission is for a minor change (component color) to an existing device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This document does not describe an algorithm or AI.
7. The type of ground truth used
"Ground truth" in the typical sense of clinical validation is not applicable here. The "ground truth" for this submission's performance testing was the ability of the device components (after a color change) to perform their intended mechanical functions (opening, closing, articulating) without issues, verified by visual inspection after aging.
8. The sample size for the training set
Not applicable. This document does not describe an AI or an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI or an algorithm that requires a training set.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.