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The Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring is indicated for the correction of mitral valvular 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 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 of chordae tendineae, or chordal hypertrophy.

The Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring, model 4100 (IMR ETlogix) is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber covered with a woven polyester cloth.

This 510(k) premarket notification for the Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring, model 4100, does not contain information about specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details regarding diagnostic performance.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria. The key sections stating this are:

• Comparative Analysis: "It has been demonstrated that the Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring is comparable to the predicate devices in design, intended use, materials, and principal of operation."
• Functional/Safety Testing: "The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring has successfully completed design verification testing."
• Conclusion: "The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring is substantially equivalent to the predicate devices."

Therefore, I cannot populate the table and answer your specific questions about acceptance criteria, study details, and performance metrics as they are not present in the provided text. The document does not describe a study involving diagnostic performance, human readers, or ground truth establishment.

A 510(k) submission typically aims to show that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove novel performance against specific quantitative criteria, especially for Class II devices like this annuloplasty ring. The "design verification testing" mentioned would primarily ensure the device meets its own internal design specifications and safety requirements, rather than a diagnostic performance study.

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