(77 days)
The SJM™ Rigid Saddle ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus.
For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of that ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed while mark relongation or rupture of the chordae tendineae and for insufficiencies with valve ado to blongation ements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.
The SJM™ Rigid Saddle Ring assembly consists of a rigid core machined from titanium covered with a double velour polyester fabric with a sewing cuff created for suturability. The ring is mounted on a holder and placed in a dual barrier package system. The package system is then steam sterilized. The SJM™ Rigid Saddle Ring is available in sizes 24mm-34mm (even sizes). Sizing is based on the inter-commissural distance as indicated by the commissure markers placed on the ring.
The provided text describes a 510(k) premarket notification for the "SJM™ Rigid Saddle Ring" (Model RSAR). This submission aims to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria through a study with acceptance criteria in the same way one might for a novel device or AI software. Therefore, much of the requested information regarding acceptance criteria, extensive studies, expert ground truth, and training sets for an AI device is not directly applicable.
However, I can extract and present the information available from the document in a structured way that aligns with your request where possible, and clearly state when information is not provided or applicable.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify "acceptance criteria" in a quantitative sense as might be typical for a new device's performance study (e.g., minimum sensitivity/specificity). Instead, the submission relies on demonstrating substantial equivalence to a predicate device based on characteristics and non-clinical testing. The "reported device performance" is the conclusion that it is "safe and effective for the intended use" and "substantially equivalent" to predicate devices.
| Characteristic Tested (Non-Clinical) | Acceptance/Equivalency Standard | Reported Device Performance |
|---|---|---|
| Product Labeling | Substantially Equivalent | Substantially Equivalent |
| Intended Use | Substantially Equivalent | Substantially Equivalent |
| Physical Characteristics | Substantially Equivalent | Substantially Equivalent |
| Anatomical Sites | Identical | Identical |
| Target Population | Substantially Equivalent | Substantially Equivalent |
| Performance Testing | Substantially Equivalent | Substantially Equivalent |
| Safety Characteristics | Substantially Equivalent | Substantially Equivalent |
| Ring Tensile Strength | Not explicitly stated | Conducted |
| Ring Compressive Strength | Not explicitly stated | Conducted |
| Suture Pullout Test | Not explicitly stated | Conducted |
| Needle Penetration Test | Not explicitly stated | Conducted |
| Computational Structural Analysis | Not explicitly stated | Conducted |
| Holder Evaluation | Not explicitly stated | Conducted |
| Assembled Ring/Holder Evaluation | Not explicitly stated | Conducted |
| MR Safety | Not explicitly stated | Conducted |
| Package Shelf Life Evaluation | Not explicitly stated | Conducted |
| Manufacturing Process Validation | Not explicitly stated | Conducted |
| Biocompatibility Evaluation | Not explicitly stated | Conducted |
| Chemical and Morphological Evaluation | Not explicitly stated | Conducted |
| Sterilization Validation | Not explicitly stated | Conducted |
| Bioburden | Not explicitly stated | Conducted |
| Pyrogenicity | Not explicitly stated | Conducted |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The submission details "non-clinical tests" but does not specify the sample sizes for these tests or the origin of any data (as it's not a study on patient data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a submission for a medical device (an annuloplasty ring), not an AI device requiring expert-established ground truth from medical imaging or patient data. The "ground truth" for a mechanical device would be laboratory measurements against relevant standards or engineering specifications.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable as this is a medical device, not an AI or imaging diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests conducted, the "ground truth" would be established by engineering specifications, material science standards, and accepted physiological/biocompatibility benchmarks. The document lists tests like "Ring Tensile Strength," "Biocompatibility Evaluation," and "Sterilization Validation," implying that these were assessed against a set of predetermined criteria based on these standards.
8. The sample size for the training set
This information is not applicable as this is a medical device, not an AI device trained on data.
9. How the ground truth for the training set was established
This information is not applicable as this is a medical device, not an AI 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.”