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The Edwards® GeoForm™ Annuloplasty Ring is indicated for the correction of mitral valve insufficiency where the lesions are not so severe as to require total valve replacement.

The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendineae.

The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus.

For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

The GeoForm Annuloplasty Ring, Model 4200, is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.

The provided text is related to a 510(k) premarket notification for a medical device (GeoForm™ Annuloplasty Ring). It describes the device, its indications for use, and its substantial equivalence to predicate devices based on design, intended use, materials, and principle of operation.

However, the document does not contain any information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert-based reviews that would typically be associated with a study report or clinical trial. The "Functional/Safety Testing" section simply states that the device "successfully completed design verification testing," but provides no specifics on what that testing entailed, what acceptance criteria were used, or what the results were.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The requested information is simply not present in this 510(k) summary and associated FDA letter. This type of document typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria.

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