(77 days)
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are implantable, adjustable flexible, annular bands (Figure II.1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of tubular braided Polyester. The band contains circumferential flexible radiopaque markers. The entire circumference of the band is radiopaque.
The bands are available in the following six sizes: 25 mm, 27 mm, 29 mm, 31 mm, 33 mm, 35 mm, 37mm and 39mm. The size refers to the equivalent inner circumference of the band, trigone to trigone.
The provided text describes a medical device, the ATS SIMULUS® Adjustable Flexible Annuloplasty Band Model 735AC, and its clearance process through a 510(k) premarket notification. However, it does not contain the specific information requested regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets as one would expect for an AI/CADe device.
The document is a 510(k) summary for a medical implant (an annuloplasty ring), which is a physical device, not a software or AI/CADe device. The "Testing Summary" section refers to mechanical testing, biocompatibility, and sterility validation, which are typical for implantable hardware. There is no mention of diagnostic performance metrics like sensitivity, specificity, or AUC, nor any reference to AI algorithms, ground truth establishment by experts, or sample sizes related to AI model development.
Therefore, I cannot populate the requested table and sections based on the provided text, as the information is not present. The document focuses on establishing substantial equivalence to a predicate device based on design, materials, surgical technique, and intended use for a physical medical product.
§ 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.”