(33 days)
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral 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 mitral annulus and restrict expansion of the annulus.
The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR 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 closecoiled MP35N spring, the two ends of which are joined together by a miniature MP35N coupler in the mid-anterior segment. The entire circumferential of the annuloplasty ring is radiopaque. The rings are available in the following six sizes: 24mm, 26mm, 28mm, 30mm, 32mm, 36mm, 36mm and 40mm. The size refers to the lateral diameter of the stiffener band.
The provided text is a 510(k) premarket notification for a medical device, the ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ring Model 800SR. It describes the device, its intended use, and states that testing was performed. However, it does not contain the detailed results of specific performance studies or acceptance criteria for those studies.
The "Testing Summary" section notes: "Testing included LAL, Sterility Validation, and Class VI Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."
This statement confirms that testing was done and the results were deemed satisfactory, but it does not provide the quantitative acceptance criteria or the specific performance metrics achieved. Therefore, I cannot generate the requested table or answer the detailed questions about the study design, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on establishing substantial equivalence to a predicate device (Genesee Biomedical Inc's. Sculptor® Semi-Rigid Mitral Annuloplasty Ring Model 605M (K905175)) based on design, material composition, surgical technique, and intended use, rather than presenting a detailed performance study against specific acceptance criteria.
In summary, the information required to answer your request (acceptance criteria, specific performance data, study design details etc.) is not present in the provided text.
§ 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.”