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The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure.

This submission describes a bone plate intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). It is designed to provide fixation to an advanced anterior mandibular bone segment. Screw holes allow for attachment to the anterior mandible and the osteotomized segment. 1.7 mm and 2.0 mm diameter screws are used to attach the plate to bone.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification summary for a device called the "Lee Plate," which is a bone plate used for internal fixation in mandibular osteotomies.

While it mentions the intended use, material, and design, it lacks the specific study details such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for the training set.

The document primarily focuses on establishing substantial equivalence to a predicate device (Profil-O-Plastic Chinplate) based on similarities in intended use, material, design, and operational principle, rather than presenting a performance study against specific acceptance criteria.

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