(30 days)
The CG Future® Annuloplasty 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 CG FUTURE Band is a single use, permanent, semi-rigid, implantable device intended for the repair of a patient's mitral valve. The CG FUTURE Band consists of a partial band of polyester fabric covering a formed, metallic (MP35N) wire stiffener material with eyelets formed at both ends. The stiffener element is over-molded with LSR silicone. The band is marked at three locations (the two trigone locations and the center) with green-colored suture. Two trigone markers identify the eyelets in the stiffener to facilitate anchoring of the stiffener into the trigones by the surgeon with sutures. The individual band size (26, 28, 30, 32, 34, 36, and 38mm) represents the widest, straight-line distance as measured at the inside of the fabric-covered band. The band is designed for implantation in the mitral position only. The CG FUTURE Band is used with associated accessories that include a holder, sizers and a handle. Implantation of the band is aided with the disposable band holder. The band is released from the holder by cutting suture at two points. The CG FUTURE Band sizer set is used to assess appropriate band size. The sizers cover all seven sizes of the CG FUTURE Band and are marked with the band size and the trigone locations. The sizers are reusable and are provided non-sterile. The reuseable annuloplasty handle, which is available in two lengths, interfaces with both the holder and the sizers.
The provided document is a 510(k) summary for the CG Future® Annuloplasty Band, describing a device modification. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed performance data from a clinical study for acceptance criteria.
Therefore, many of the requested items (e.g., specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) cannot be extracted from this document as it's not a clinical trial report.
However, based on the summary, here is the information that can be extracted or reasonably inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. It generally states that "The CG FUTURE Band 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."
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (General Statement in the document) |
|---|---|
| (Presumably, "modifications do not affect intended use or performance") | "The modifications to the predicated device are appropriate and do not affect the intended use or performance of the device." |
| (Implicit: Maintain same safety and effectiveness as predicate) | (Implicitly achieved by demonstrating substantial equivalence to the predicate device K011395) |
2. Sample size used for the test set and the data provenance
Not explicitly stated. The "verification and validation studies" mentioned are typically engineering and bench tests for device modifications, not clinical efficacy studies with patient 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 not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 a medical device modification submission, not an AI-assisted diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance is assessed against engineering specifications and the predicate device's established performance, not against a clinical ground truth like pathology for diagnosis.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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.”