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The Compression Plate 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™ Compression Plate consists of 3 sizes of plates and 2.7mm lockingscrews varying in length from 12mm to 24mm. All plates and screws are manufactured from stainless steel.

This document pertains to the 510(k) summary for the CHARLOTTE™ Compression Plate, a medical device for bone fixation. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML device.

The provided text is a 510(k) premarket notification for a traditional medical device (a bone compression plate) and therefore, the questions posed, which are tailored for AI/ML device evaluations, are not applicable.

Here's why and what information is available:

• Device Type: The CHARLOTTE™ Compression Plate is a physical implantable device made of stainless steel for bone fixation. It is not an AI/ML device, nor does it appear to incorporate any AI/ML components.
• Approval Pathway: The document describes a 510(k) submission, which demonstrates substantial equivalence to a legally marketed predicate device (Compression Staple, K043059). This process primarily evaluates safety and effectiveness compared to an existing device, rather than requiring extensive performance studies against specific "acceptance criteria" for an AI/ML output.

Therefore, I cannot provide answers to the requested points (1-9) as they relate to the evaluation of AI/ML performance.

What the document does provide:

• Intended Use: For fixation in various foot and ankle procedures (LisFranc arthrodesis, osteotomies, arthrodeses, etc.).
• Device Description: Consists of 3 sizes of plates and 2.7mm locking screws, all made from stainless steel.
• Substantial Equivalence: Claimed to be substantially equivalent to the previously cleared Compression Staple (K043059) in design features, material, and indications for use.
• Regulatory Class: Class II medical device.
• Product Code: HRS (Orthopedics).

If you have a document describing an AI/ML device, I would be happy to help assess its acceptance criteria and study details.

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