(116 days)
The AnnuloFlex annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.
This document is a 510(k) summary for the Sulzer Carbomedics AnnuloFlex™ Annuloplasty System. This device is a medical implant, not an AI or software device, so the typical acceptance criteria and study designs associated with AI performance metrics (like sensitivity, specificity, F1-score, sample sizes for test/training sets, expert adjudication, MRMC studies) are not applicable.
Instead, the "acceptance criteria" for such a device are based on demonstrating substantial equivalence to legally marketed predicate devices, supported by biocompatibility and mechanical efficacy testing.
Here's an breakdown of the information provided in the context of a medical device submission:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Testing Results) |
|---|---|
| Material Biocompatibility: Materials used must be non-toxic, non-hemolytic, and non-pyrogenic. | Completed. Testing supports that "the materials used in the manufacture of the AnnuloFlex™ are non-toxic, non-hemolytic, and non-pyrogenic." |
| Mechanical Efficacy: The device must withstand forces and demonstrate comparable performance to predicate devices in terms of its intended function. | Suture Retention Testing: Demonstrated that "the sewing ring fabric is comparable to fabrics used in vascular prostheses." Overall Mechanical Testing: Testing "demonstrated that the AnnuloFlex™ Annuloplasty Ring is substantially equivalent to the predicate devices for repair of the mitral valve" in terms of function, materials, and manufacturing processes where applicable. The predatory devices are: * Sulzer Carbomedics® AnnuloFlo™ Annuloplasty Ring (rigid, nearly identical materials, identical manufacturing process, identical function) * Medtronic Duran Flexible Ring (flexible complete ring with identical function) * Baxter Cosgrove-Edwards Ring (flexible partial ring with identical function) |
| Intended Use: The device must be suitable for its stated intended use. | The AnnuloFlex™ System is intended for use in the repair of the human cardiac mitral valve, specifically as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. It should be used only if the valve is repairable and not requiring replacement. |
| Technological Characteristics: Comparable to predicate devices in design and function. | Described as a flexible annuloplasty ring that can be implanted as a partial or complete ring. Compared against predicate devices for being flexible/rigid, complete/partial rings, with comparable materials, manufacturing processes, and identical function. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of this device. The testing described (biocompatibility, mechanical suture retention) are laboratory-based tests on the device materials and components, not a "test set" of patient data or images.
- Data Provenance: Not applicable. The testing represents lab-generated data from material and mechanical assessments of 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. Ground truth for AI software involves expert labels of data. For a hardware medical device like this, "truth" is established through engineering specifications, material science, and mechanical testing standards.
4. Adjudication method for the test set:
- Not applicable. There is no expert adjudication of a "test set" in the sense of AI performance evaluation. The data is physical test results against pre-defined engineering and safety standards.
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, an MRMC study was not done. This device is an implanted annuloplasty ring, not an AI or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For this device, the "ground truth" (or functional equivalent for a hardware device) is based on established biocompatibility standards (e.g., ISO 10993 for non-toxicity, non-hemolysis, non-pyrogenicity) and mechanical engineering standards for durability, suture retention, and performance under simulated physiological conditions. It also relies heavily on the documented performance and safety profiles of the predicate devices to which it claims substantial equivalence.
8. The sample size for the training set:
- Not applicable. There is no "training set" for physical medical device testing in the AI sense.
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.”