(29 days)
The CG Future® Annuloplasty Ring and Band is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.
The Model 638R CG Ring is based on the marketed released Model 638B CG Band and Model 620R/620B Duran Product Family. The CG Ring is a semi-rigid annuloplasty ring intended for remodeling and/or reconstruction of pathological mitral valves. Similar to the CG Ring is composed of a C-shaped metal stiffener that is covered with silicone and fabric. Unlike the CG Future Band but similar to the Duran Product Family, the CG Ring is a fully closed ring, formed by joining the ends of the stiffener with suture and fabric, resulting in a D-shaped device. In addition, a similar radiopaque strip that is used in the Duran Product Family is placed between the stiffener ends for identification of the device on X-ray.
The disposable CG Ring Holder provides for attachment of the ring, guides the implantation of the ring, and interfaces with the Model 7615 Annuloplasty Handle. There are eight (8) sizes for the holder (24, 26, 28, 30, 32, 34, 36, and 38 mm), and a single holder is provided with each packaged ring assembly. The CG Ring packaging consists of double-aseptic pouches (containing the ring attached to its holder). The pouch assembly is placed in a shelf carton box along with instructions for use and product traceability labels for shipping.
The provided text describes a 510(k) premarket notification for the CG Future® Annuloplasty Ring. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it states: "The CG Ring was subjected to verification and validation studies. The verification/validation studies demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device."
This implies that the "acceptance criteria" were qualitative and related to ensuring the new device (CG Ring) performed equivalently and safely to its predicate devices (CG Future® Annuloplasty Band and Duran AnCore® Ring and Band) after its design modifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "verification and validation studies" are mentioned, but no details on their design, sample size, or data provenance are given.
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 applicable and not provided. The study mentioned is likely engineering or bench testing, not a clinical study involving experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and 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 information is not applicable and not provided. The device is an annuloplasty ring, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. For an annuloplasty ring, "ground truth" would be related to its mechanical and biological performance, likely assessed through bench testing and potentially animal or limited human observational studies to confirm functionality and safety, rather than a diagnostic "ground truth."
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
In summary, the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria. The "performance data" section is a high-level statement indicating that verification and validation studies were done to ensure the modifications didn't negatively impact the device, but it doesn't provide the specifics of those studies.
§ 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.”