(225 days)
TransForm McCarthy Mitral Annuloplasty Ring is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.
The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid annuloplasty ring for mitral valve repair with the stiffened portions at the anterior and posterior segments. The ring is flexible at the commissure regions to allow physiological movement of the annulus. Stiffener placement allows the ring to maintain its "D" saddle shape during systole and a flastole. The stiffeners consist of MP35N 0.71 mm diameter (polished and formed) alloy. An elastic silicone core and braided polyester fabric form the ring body. The TransForm Annuloplasty Ring has four green radial markers at the left and right trigones and two markers at the mid-anterior and mid-posterior. The natural mitral annulus throughout the cardiac cycle. The interrupted stiffeners within the silcone core provide semi-rigid elastic flexibility. Elasticity of the "D" to "O" or circular transformation, accommodates remodeling of the annulus, while creating inward forces to maintain circular annular qeometry aqainst physical expansion. The size range of TransForm is from 24mm with 2mm increments. Size refers to the internal CC diameter of the ring. Rings are intended to be implanted on the patient's mitral annulus to reduce and stabilize the annulus.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, specifically regarding an AI/ML device. The document is an FDA 510(k) clearance letter for a medical device called the "TransForm McCarthy Mitral Annuloplasty Ring."
This document focuses on the substantial equivalence of this annuloplasty ring to existing predicate devices, outlining its design, materials, and non-clinical tests (e.g., tensile strength, sterilization, biocompatibility). It does not discuss AI/ML acceptance criteria, AI/ML device performance, ground truth establishment for AI/ML, sample sizes for AI/ML test/training sets, or MRMC studies.
Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and studies based on 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.”