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The TruForm™ Sievers Annuloplasty Ring is indicated for the correction of mittal valvular insufficiency where the lessions are not so severe as to require total valve replacement.

The TruForm™ Sievers Annuloplasty Ring, Model TRH is a semi-flexible implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of braided polyester encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in ten (10) sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm; 36 mm; 38 mm; 40 mm; and 42 mm.

The provided text describes the regulatory clearance for a medical device called the TruForm™ Sievers Annuloplasty Ring, Model TRH. It is a 510(k) premarket notification, which means the device is being declared substantially equivalent to existing, legally marketed predicate devices.

However, the document does not describe a study involving an algorithm or AI, nor does it present acceptance criteria for an AI device. The TruForm™ Sievers Annuloplasty Ring is a physical medical implant used for cardiac surgery.

Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets them in the context of an AI device. The document focuses on the equivalence of a physical annuloplasty ring to its predicates through non-clinical testing and shared characteristics.

If there was a misunderstanding and the request was for a physical device, the acceptance criteria are generally met by demonstrating substantial equivalence to a predicate device through:

• Same intended use and indications for use.
• Similar technological characteristics.
• Addressing any differences that could raise new questions of safety and effectiveness through testing.

The non-clinical tests performed for this physical device to support substantial equivalence include:

• Biocompatibility
• Sterilization
• Computational Finite Element Analysis (FEA)
• Tensile strength of ring materials
• Suture pull-out testing
• MRI Compatibility
• Packaging
• Shelf-life

These tests demonstrate that the device is equivalent to the predicate and/or reference devices, implying it meets the safety and performance requirements for its intended use.

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