(28 days)
The SJM® Seguin annuloplasty ring is indicated for use in the repair of a mitral valve that is diseased or damaged due to acquired or congenital processes.
The Seguin ring is a semi-rigid ring fabricated from an untra-high molecular weight polyethylene (PE) core surrounded by a polyester sewing ring. providing a means for attaching the ring to the heart annulus as well as a suitable surface for tissue ingrowth.
The provided text (K014037) describes a 510(k) premarket notification for the SJM® Seguin annuloplasty ring, focusing on its substantial equivalence to a predicate device (Seguin ring, model SAR). This submission is for a medical device (an annuloplasty ring) and not an AI/ML software device. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size) are not applicable or described in this document.
The acceptance criteria and study information provided in this document are primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance metrics against specific acceptance criteria for a novel AI algorithm.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Product Labeling: Substantially Equivalent to predicate | Substantially Equivalent |
| Intended Use: Identical to predicate | Identical |
| Physical Characteristics: Substantially Equivalent (with noted differences in holder/handle) | Different (Holder and Handle only) but overall function maintained |
| Anatomical Sites: Identical to predicate | Identical |
| Target Population: Identical to predicate | Identical |
| Performance Testing: Substantially Equivalent to predicate (prior testing on predicate) | Substantially Equivalent |
| Safety Characteristics: Substantially Equivalent to predicate | Substantially Equivalent |
| New Holder/Handle Configuration: Function as intended | Physical Testing performed: Holder to Handle connection, Holder assembly, Ring assembly to holder. (No specific performance metrics are reported, but successful testing is implied for substantial equivalence). |
| Biocompatibility: As per predicate | Biocompatibility testing performed. |
| Sterility Assurance: As per predicate | Sterility Assurance testing performed. |
| EtO Residual Evaluation: As per predicate | EtO Residual Evaluation performed. |
| Manufacturing Process Validation: As per predicate | Manufacturing Process Validation performed. |
The document states that the SJM® Seguin annuloplasty ring, model SARP, is considered "substantially equivalent" to its predicate device, the Seguin ring, model SAR. The performance criteria are implicitly met by demonstrating this substantial equivalence through comparison of characteristics and specific non-clinical tests.
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. The study is a non-clinical evaluation comparing a new device iteration to a predicate, not a clinical study with patient data or a test set in the context of AI/ML.
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 is a medical device submission based on substantial equivalence, not an AI/ML algorithm requiring expert ground truth establishment.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance and safety established for the predicate device (Seguin ring, model SAR), which was previously cleared by the FDA (K961246). The new device (model SARP) is demonstrated to be substantially equivalent to this established "truth" through comparative non-clinical testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.”