(172 days)
The AnnuloFlo™ System is intended for use in the repair of the human cardiac mitral valve. The AnnuloFlo™ 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 AnnuloFlo™ System consists of an annuloplasty ring, and a complete set of instrumentation provided in a tray to properly size the annulus and implant the annuloplasty ring. The annuloplasty ring is designed to reinforce the native annulus while revailing the native appratus.
This document describes the "AnnuloFlo™ System" (K970375), an annuloplasty ring for human cardiac mitral valve repair. The provided text is a 510(k) summary and the FDA's clearance letter, which focuses on regulatory approval and substantial equivalence rather than a detailed scientific study with specific acceptance criteria and performance metrics.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text. The document is a regulatory submission summary, not the full study report.
Here's what can be extracted and what is explicitly not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic, non-hemolytic, non-pyrogenic | "Material biocompatibility testing has been completed and supports these materials are non-toxic, non-hemolytic, and non-pyrogenic." (Reference to materials common to C.PHV) |
| Mechanical Performance | Suture retention strength comparable to other vascular prostheses fabrics | "suture retention testing to demonstrate that the [fabric] is comparable to fabrics used in other vascular prostheses." |
| Packaging & Sterilization | Five-year shelf life; same sterilization cycle as CPHV | "Package integrity testing to validate a five year shelf life has been conducted on this package. ... is sterilized in the same sterilizer, the same sterilization cycle as the CPHV." |
| MRI Compatibility | Non-ferrous, does not present a significant risk during MRI | "All materials are non-ferrous, have extensive history in implants and do not present a significant risk during Magnetic Resonance Imaging (MRI)." |
| Substantial Equivalence | Device is substantially equivalent to a predicate device (Carpentier-Edwards Classic™ Annuloplasty Ring) | FDA determination: "we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available. The document summarizes testing but does not provide details on sample sizes for specific mechanical or biocompatibility tests, nor does it describe a "test set" in the context of, for example, clinical performance or image analysis. The data provenance is also not specified.
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)
- Not applicable / Not available. This device is a physical medical implant, not an AI/diagnostic software. "Ground truth" in this context would relate to the validity of material properties or mechanical performance, which are evaluated through standardized tests, not expert consensus in the way a diagnostic AI would be. No information about expert involvement in establishing "ground truth" for the tests mentioned is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not available. As above, this pertains more to diagnostic accuracy studies involving human interpretation or complex data, not the material and mechanical testing described for this device.
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, not done. This is an implantable medical device, not an AI or diagnostic tool. MRMC studies are not relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable. This is an implantable medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Established biological safety standards and in-vitro testing criteria (implied by "non-toxic, non-hemolytic, non-pyrogenic").
- For mechanical performance: Standardized ASTM test methods (e.g., for suture retention strength) and comparison to established predicate device performance or industry standards.
- For shelf life: Accelerated aging studies and package integrity tests (implied).
- For MRI compatibility: Material properties (non-ferrous) and potentially specialized testing for interaction with MRI fields (implied).
8. The sample size for the training set
- Not applicable / Not available. The device is not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not available. No training set exists.
§ 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.”