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The Sulzer Carbomedics AnnuloFlex™ Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral and 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 AnnuloFlex™ 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 and implant the annuloplasty ring.

This report describes the acceptance criteria and the study that proves the device meets those criteria for the AnnuloFlex™ Annuloplasty System. However, it's important to note that the provided documents are from a 510(k) premarket notification and primarily focus on demonstrating substantial equivalence to predicate devices, rather than a rigorous study with acceptance criteria and statistical performance metrics typically seen in AI/ML device submissions.

Here's an analysis based on the provided text, structured to answer your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

• Identical materials, manufacturing, and function to the Sulzer Carbomedics® AnnuloFlex™ Annuloplasty Ring (a previous version).
• Identical function to the Medtronic Duran Flexible Ring (complete ring).
• Identical function to the Baxter Cosgrove-Edwards Ring (partial ring). |

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of evaluating an AI/ML device. The testing mentioned refers to:

• Biocompatibility testing on device materials.
• Mechanical testing (e.g., suture retention) on the device components.
• Comparison of the device's design, materials, and function to existing predicate devices already on the market.

Therefore, there is no mention of a sample size for a test set or data provenance related to clinical data for performance evaluation in the way an AI/ML device would be assessed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission is for a medical device (annuloplasty ring), not an AI/ML diagnostic or therapeutic device that would require expert-established ground truth for a test set. The "ground truth" for this device's performance is established through physical, mechanical, and biocompatibility testing, and comparison to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of a clinical performance evaluation that would necessitate an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a physical medical device, not a software or AI/ML device. An MRMC study is not relevant to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device; there is no "algorithm" or standalone performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for this device can be interpreted as:

• Biocompatibility Standards: The established scientific understanding and regulatory requirements for materials to be non-toxic, non-hemolytic, and non-pyrogenic when in contact with human tissue.
• Mechanical Engineering Principles and Standards: The expected performance characteristics of a medical implant in terms of material strength, durability, and suture retention.
• Clinical Efficacy of Predicate Devices: The proven safety and effectiveness of the legally marketed predicate annuloplasty rings for their intended use. The new device's "ground truth" for clinical utility is essentially its demonstrated similarity to these established devices.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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