(30 days)
The Edwards® MC3 Tricuspid Annuloplasty System is intended for use in patients to correct annular dilatation, increase leaftet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
The Edwards MC3 Tricuspid Annuloplasty System, Model 4900, consists of two primary components; the implantable annuloplasty ring and the template/lanyard assembly (or holder). The implantable annuloplasty ring is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML medical device.
The provided text is a 510(k) summary for a mechanical medical device, the "Edwards MC3 Tricuspid Annuloplasty System." It details the device's description, indications for use, and a comparison to a predicate device to establish substantial equivalence.
Specifically, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document describes a traditional medical device (an annuloplasty ring), not an AI/ML device. Therefore, there are no performance metrics related to AI/ML algorithms or acceptance criteria for such metrics.
- Sample size used for the test set and the data provenance: No test set for an AI/ML algorithm is mentioned. The "Functional/Safety Testing" section states the device "successfully completed design verification testing," which refers to engineering and quality assurance tests for the physical device, not an AI/ML model's performance on a dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/ML algorithm or associated ground truth establishment described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided content is a regulatory submission for a physical medical device, not an AI/ML-driven device, and therefore lacks all the requested information pertaining to AI/ML performance evaluation.
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”