(31 days)
The Attune™ Adjustable Flexible Annuloplasty Ring is indicated for use in the repair of a mittal or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the Attune™ Adjustable Flexible Annuloplasty Ring
The Attune™ Adjustable Flexible Annuloplasty Ring is a fully flexible ring fabricated with a medical grade silicone rubber core surrounded by polyester fabric and containing a suture that will allow adjustment after implantation.
This document, K083835, is a 510(k) premarket notification for the Attune™ Adjustable Flexible Annuloplasty Ring. It aims to demonstrate substantial equivalence to a predicate device, the Tailor Annuloplasty Ring Model TARP-(size) (K014161). The focus of this document is on the physical and safety characteristics of an anulloplasty ring, not on software performance, algorithms, or AI. Therefore, most of the questions you've asked about acceptance criteria and studies related to AI or algorithm performance cannot be answered from this text.
However, I can extract information regarding the non-clinical tests performed on the device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or detailed reported device performance results. It only lists the types of performance characteristics evaluated, asserting that the device is "safe and effective for the intended use" and "substantially equivalent" to the predicate.
| Characteristic Evaluated | Reported Device Performance (Summary) |
|---|---|
| Ring Tensile Strength | Substantially Equivalent to predicate, safe and effective |
| Suture Pullout Test | Substantially Equivalent to predicate, safe and effective |
| Ring Adjustability Test | Substantially Equivalent to predicate, safe and effective |
| Security of Final Adjustment Knot Test | Substantially Equivalent to predicate, safe and effective |
| MR Safety Evaluation | Substantially Equivalent to predicate, safe and effective |
| Manufacturing Process Validation | Substantially Equivalent to predicate, safe and effective |
| Biological Evaluation | Substantially Equivalent to predicate, safe and effective |
| Sterilization Parameter Evaluation | Substantially Equivalent to predicate, safe and effective |
2. Sample sized 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 document describes non-clinical engineering tests (e.g., tensile strength, suture pullout) rather than a clinical study with a test set of data.
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. This document pertains to physical device testing, not expert-adjudicated ground truth for algorithms or diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document pertains to physical device testing.
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 document is not about AI-assisted diagnosis or multi-reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not about an algorithm or software.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests listed, the "ground truth" would be established engineering standards, material specifications, and regulatory requirements for medical devices. For the biological evaluation, it would likely refer to biocompatibility standards. For MR Safety, it would be based on MRI compatibility guidelines and testing.
8. The sample size for the training set
Not applicable. This document is not describing an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document is not describing an algorithm that requires a training set.
§ 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.”