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The CHARLOTTE™ CLAW® 3.5 is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The CHARLOTTE™ CLAW® 3.5 consists of curved 4-hole plates and locking screws of various lengths. All plates and screws are manufactured from stainless steel.

I am sorry, but the provided text is a 510(k) summary for a medical device (CHARLOTTE™ CLAW® 3.5), which is a compression plate used for bone fixation. This type of document is for regulatory approval and does not contain any information about acceptance criteria, study design, or performance metrics typically associated with AI/ML-based medical devices.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document focuses on establishing substantial equivalence to a predicate device based on design features, materials, and analysis data, not on clinical performance studies or AI/ML model validation.

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