(190 days)
The Shelhigh BioRing™ is intended for use in the repair of the human cardiac mitral valve.
The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.
The Shelhigh BioRing™ consists of circular rings made of Polyester material and covered with No-React processed pericardium.
This document is a 510(k) summary for the Shelhigh BioRing and describes its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way typically expected for an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for a performance study evaluating an AI/ML component is not applicable to this document.
However, I can extract the information that is present and indicate where the requested details are not available.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria for device performance based on a study, nor does it report specific performance metrics in that context. The "acceptance criteria" here are related to demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and technological characteristics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate devices (repair of human cardiac mitral valve) |
| Technological Characteristics | Similar to predicate devices (circular rings, polyester material, No-React processed pericardium) |
| Material Properties | Good tensile strength, good suture retention |
| Biocompatibility | Non-toxic, non-hemolytic, non-pyrogenic; Passed all required biocompatibility tests |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a performance study with a test set. The evaluation is based on a comparison to predicate devices and material testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No test set or ground truth establishment by experts is described in this context.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
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 device is an annuloplasty ring, not an AI/ML device. Therefore, no MRMC study involving AI assistance was conducted or would be relevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
Not applicable. For this type of medical device (physical implant), "ground truth" would relate to factors like material specifications, biocompatibility test results, and clinical outcomes for the predicate devices, rather than an expert-adjudicated dataset. The document states that the materials "passed the requirements of all tests," implying a comparison to established standards for safety and performance (biocompatibility, tensile strength, suture retention).
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component, thus no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML component, thus no training set or its associated ground truth.
§ 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.”