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The MedicalCV, Inc. Northrup Universal Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

The Northrup Universal Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus.

The provided text describes the Northrup Universal Annuloplasty System™, a medical device, and its approval process by the FDA. However, the text does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria.

The document is a "Summary of Safety and Effectiveness" (K033685) for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study with acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or human-in-the-loop study results, as this information is not present in the provided text.

The text primarily details:

• Device Description: An annuloplasty ring for mitral or tricuspid valve repair.
• Intended Use: Reinforcement for repair of damaged cardiac valves (acquired or congenital disease), or replacement of a previously implanted ring, for repairable valves.
• Technological Comparison: Compared to predicate devices like CarboMedics AnnuloFlex Annuloplasty System (K992056), Edwards Lifesciences Cosgrove-Edwards Annuloplasty System (K923367), and Baxter Carpentier-Edwards Physio Annuloplasty Ring (K926138).
• Testing: Mentions biocompatibility testing (non-toxic, non-hemolytic, non-pyrogenic under GLP) and suture retention testing, which demonstrated "more than adequate retention force as compared to the predicate device." It concludes the device is "substantially equivalent" to predicate devices.
• FDA Approval: A letter from the FDA confirming substantial equivalence for the stated indications for use, allowing the device to be marketed.

In summary, the provided document focuses on regulatory approval (510(k) clearance) based on substantial equivalence, and not on detailed performance metrics, acceptance criteria, or clinical study results as you've requested.

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