(29 days)
The SJM™ Seguin annuloplasty ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.
The SJM Seguin Ring is a semi-rigid ring fabricated from an ultra-high molecular weight polyethylene core surrounded by a polyester sewing cuff, which provides a means for attaching the ring to the mitral annulus as well as a suitable surface for tissue ingrowth.
The provided document is a 510(k) summary for the SJM Seguin Annuloplasty Ring. It does not describe a study involving an AI or an algorithm-based device, nor does it provide acceptance criteria or performance data in the typical sense for such devices.
Instead, this document is a regulatory submission for a medical implant (an annuloplasty ring) and focuses on establishing substantial equivalence to a predicate device. The "performance testing" mentioned refers to non-clinical, bench-top tests of mechanical properties and biocompatibility, not a clinical study to evaluate detection accuracy, sensitivity, or specificity.
Therefore, many of the requested elements (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission for this particular device.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document lists performance characteristics that were "evaluated" but does not provide a table with specific acceptance criteria or quantitative performance results for these evaluations. It broadly states that the device is "safe and effective."
| Item | Acceptance Criteria (Not Explicitly Stated for this Device) | Reported Device Performance (Not Explicitly Stated for this Device) |
|---|---|---|
| Ring Tensile Strength | (Presumed to meet internal specifications and predicate performance) | (Evaluated, outcome inferred to be acceptable) |
| Ring Compression Strength | (Presumed to meet internal specifications and predicate performance) | (Evaluated, outcome inferred to be acceptable) |
| Suture Pullout Test | (Presumed to meet internal specifications and predicate performance) | (Evaluated, outcome inferred to be acceptable) |
| MR Safety Evaluation | (Presumed to meet relevant safety standards) | (Evaluated, outcome inferred to be acceptable) |
| Manufacturing Process Valid. | (Presumed to be validated to ensure consistent quality) | (Evaluated, outcome inferred to be acceptable) |
| Biological Evaluation | (Presumed to meet biocompatibility standards) | (Evaluated, outcome inferred to be acceptable) |
| Sterilization Parameter Eval. | (Presumed to meet sterilization efficacy standards) | (Evaluated, outcome inferred to be acceptable) |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The "tests" mentioned are non-clinical, bench-top evaluations (e.g., tensile strength, compression strength, suture pullout). These typically involve a small number of physical samples (e.g., 5-10 devices) to demonstrate consistency and compliance with engineering specifications.
- Data Provenance: Not applicable in the context of clinical studies. These are laboratory-based, non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical expert review, is not relevant for these non-clinical engineering and biological evaluations. Compliance with technical standards and internal specifications would be assessed by engineers and specialists in material science, biomechanics, and biocompatibility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in clinical studies for ambiguous cases, typically involving human readers. This document describes non-clinical tests.
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. This device is a physical annuloplasty ring, not an AI or imaging diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For non-clinical tests, "ground truth" would refer to established engineering standards, material properties, and regulatory requirements (e.g., ASTM standards for tensile strength, ISO standards for biocompatibility).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of 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.”