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The Pantheon Medical Balanced Plating System is intended for fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities. This system is not intended for spinal use.

The Pantheon Medical Balanced Plating System consists of multiple plate families of various anatomical sizes and shapes, 2.7mm and 3.5mm locking and non-locking screws which mate into the plates, as well as a 4.0mm compression screw that is utilized with the Lapidus plate. Various instruments are also included to assist in implanting the system.

I'm sorry, but this document (K162154) is a 510(k) premarket notification for a medical device (Panatheon Medical Balanced Plating System), which is a bone fixation system. This document does NOT contain information about an AI/ML-driven medical device, nor does it contain any data regarding acceptance criteria, study methodologies, or performance metrics typically associated with AI/ML diagnostic tools.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for testing or data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone performance data.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, construction, and mechanical performance (e.g., ASTM standards for bone fixation), rather than diagnostic accuracy or AI performance.

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