Search Results

The Annuloplasty Band DR and Annuloplasty Ring DR are indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be correct d by appropriate repair and annular remodeling.

MiCardia's Annuloplasty Band DR™ (Model RNG6) and Annuloplasty Ring DR™ (Model RNG7) function as annular support for the mitral annulus only. The devices are fabricated from a nickel titanium support ring surrounded by silicone with a polyester fabric covering. The devices are mounted on holders, packaged in a barrier packaging system and governa sterilized. The devices are available in sizes 28 mm, 30 mm, 32 mm, 34 mm, and 36 mm. The size of the device is based on the inter-commissural markers placed on the ring. The devices are permanently implanted using sutures and typical techniques for mitral valve repair using open-heart bypass. The Annuloplasty Band DR™ and Annuloplasty Ring DR™ are used with associated accessories that include a holder, and reusable sizers (Model SZR1) and reusable handle (Model HNDL). The handle may be attached to either the sizers or the holders to aid in sizing or implantation. The diseased mitral valve annulus is measured with the appropriate MiCardia sizer. The sizers are provided in five (5) sizes; 28 mm, 30 mm, 32 mm, 34 mm, and 36 mm. The sizers are used to evaluate the distance between the patient's mitral valve commissures, anterior leaflet length and surface area, in order to select the approvial esize of annuloplasty band or ring for the repair. The appropriately sized band or ring is implanted using a series of sutures, typically 2-0 or 3-0, placed approximately 4 mm apart. The band or ring is used to reduce the mitral annulus opening thereby causing a closer approximation of the anterior and posterior leaflets. This typically creates an increase in the depth of coaptation between the anterior and posterior leaflets when they are closed and resolves the pathological mitral valve (e.g. mitral regurgitation).

This 510(k) summary (K070488) describes the premarket notification for the MiCardia Annuloplasty Band DR™ and Annuloplasty Ring DR™. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

The document describes the device, its intended use, comparison to predicate devices, and non-clinical tests conducted to demonstrate safety and effectiveness for a traditional medical device (an annuloplasty ring). There is no mention of algorithms, AI, machine learning, or software performance evaluation. Therefore, I cannot extract the requested information regarding AI device performance.

The document discusses the following:

• Device Description: Annuloplasty Band DR™ (Model RNG6) and Annuloplasty Ring DR™ (Model RNG7) are nickel titanium support rings surrounded by silicone with polyester fabric, used for mitral annular support.
• Intended Use: Reconstruction and/or remodeling of pathological mitral valves to correct valvular insufficiency and/or stenosis.
• Predicate Device: CG Future® (K011395/K052860).
• Non-Clinical Tests: Biocompatibility, Computational Structural Analysis, Ring Tensile Strength, Suture Pull-out Strength, Sterilization Validation, Bioburden and Pyrogen, Packaging and Shelf Life Analysis, Corrosion, and Magnetic Resonance Imaging Analysis. These tests are standard for implantable medical devices and do not relate to software or AI performance.

Therefore, the requested table and details about acceptance criteria for an AI device, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information cannot be provided from this document.

Ask a specific question about this device