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Synthes HTO System is an instrument and implant system intended for high tibial osteotomies to correct leg malaignments causing unicompartmental osteoarthritis.

The HTO System utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The plates are available with an anatomically contoured head. The 5.0 mm locking screw has a round cross section with a threaded conical underside to fit into the plate. The underside has a tapered thread to match the design of the plate. The locking screw is available in lengths ranging between 26 and 65 mm. Standard 4.5 mm cortex screws (lengths 80 - 100 mm) and 4.5 mm shaft screws (lengths 80 - 100 mm) are also available for use with the plates.

This document is a 510(k) submission for a medical device (Synthes High Tibial Osteotomy (HTO) System), not a study evaluating the performance of an AI/ML device. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this document.

The document describes a traditional medical device and its intended use, as well as a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of why this document doesn't contain the requested information:

1. AI/ML Device Performance: The Synthes HTO System is a physical instrument and implant system, not a software or AI/ML-based diagnostic/therapeutic tool.
2. Acceptance Criteria: For physical devices, acceptance criteria typically relate to mechanical properties, biocompatibility, sterilization, and manufacturing tolerances, not diagnostic accuracy metrics (like sensitivity, specificity, AUC) that would be relevant for an AI/ML study.
3. Study Design: The "confidential testing" mentioned is likely mechanical testing, fatigue testing, or biocompatibility testing, not a clinical study involving human readers, ground truth establishment, or multi-reader multi-case analysis.
4. Experts/Ground Truth: Concepts like "number of experts," "qualifications of experts," "adjudication method," and "type of ground truth" are specific to studies validating diagnostic accuracy, particularly for image-based AI/ML applications. They don't apply to the evaluation of a physical surgical implant system.
5. Training/Test Sets: These terms are exclusive to machine learning model development and validation.

In summary, this document is entirely outside the scope of what your request is designed to extract. If you have similar requests for documents describing AI/ML device validation studies, I would be able to provide the requested information.

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