(205 days)
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are for use in those patients undergoing surgery of diseased or damaged tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty Rings provide support for the tricuspid annulus and restrict expansion of the annulus.
The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are implantable, semi-rigid, annular Rings. The Rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a close-coiled MP35N spring. The two ends of the stiffener wire are fitted with miniature MP35N end caps at each trigone. These caps prevent the stiffener wire from poking through the end seam of the ring. The entire circumferential of the annuloplasty ring is radiopaque between trigones. The Rings are available in the following six sizes: 26mm, 28mm, 30mm, 32mm, 34mm, 36mm. The size refers to the inner major diameter of the ring.
This submission describes a medical device, the ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Ring Model 900SFC, and its equivalence to a predicate device. The document does not describe an AI/ML powered device, nor does it present any studies proving the device meets acceptance criteria related to AI/ML performance.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared device (ATS SIMULUS® Semi-Flexible Tricuspid Annuloplasty Ring Model 800SR) based on design, material composition, surgical technique, and intended use.
Here's an analysis of the provided text in relation to your request, highlighting the absence of AI/ML or related performance studies:
1. A table of acceptance criteria and the reported device performance
The document lists several mechanical tests, but these are for the annuloplasty ring's physical properties, not for any AI/ML performance. It states "All test results were satisfactory" without providing specific numerical acceptance criteria or detailed performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity: | |
| Tensile strength of flat Polyester tubular braid. | Satisfactory |
| 4-0 Suture tensile test | Satisfactory |
| Stiffener wire tensile strength. | Satisfactory |
| Body implant suture pull out strength. | Satisfactory |
| Stiffener retention seam penetration strength. | Satisfactory |
| Stress Levels: | |
| Finite Element Analysis (FEA) of the stress levels of stiffeners | Satisfactory |
| Biocompatibility: | |
| LAL (Limulus Amebocyte Lysate) | Previously carried out on predicate device |
| Sterility Validation | Previously carried out on predicate device |
| Class VI Biocompatibility | Previously carried out on predicate device |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the mechanical tests performed. Data provenance is not mentioned. As these are mechanical tests performed on components or complete bands, "country of origin of the data" and "retrospective or prospective" are not applicable in the typical sense for clinical or AI/ML studies.
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 is about a physical medical device (annuloplasty ring) and its mechanical properties, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not described here.
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 system, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the mechanical tests would be the measured physical properties or successful completion of a test according to a predefined standard, not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML algorithm or training set, this question is irrelevant to the provided document.
In summary, the provided document is a 510(k) summary for a physical medical device (an annuloplasty ring) and focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, sterility, and biocompatibility. It does not involve any AI/ML components or related performance studies.
§ 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.”