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The Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances. The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.

The provided text describes the regulatory clearance of a medical device called "Ortholock Anchorage Devices" and details its equivalence to predicate devices, primarily through bench testing. It does not include information about acceptance criteria for typical AI/ML medical devices, nor does it describe a study with performance metrics in the way these are typically presented for AI/ML device evaluations.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of information for an AI/ML device.

The document focuses on the substantial equivalence of the Ortholock Anchorage Devices to existing predicate devices based on:

• Indications for Use: Both the subject device and predicate devices are intended to provide fixed anchorage for orthodontic appliances to facilitate tooth movement in adolescents and adults, for temporary use.
• Material: All devices are made from Titanium Alloy.
• Surface Treatment: All are anodized.
• Principle of Operation: All are orthodontic implants used for anchorage of orthodontic appliances.
• Sterilization: All are provided non-sterilized and user-sterilized, with sterilization validated.
• Bench Testing: Comparative bench testing was performed for torsional properties, driving torque, axial pullout strength, and self-tapping performance, demonstrating similar mechanical performance values to the primary predicate device (The C-Type and Special Type Orthodontic Anchor Screws, K063495) and having similar characteristics to the reference device (PSM Medical BENEFIT Screw, K110392).

The information provided is for a traditional medical device (orthodontic microimplant), not an AI/ML device, and thus does not include data like sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance for an algorithm, or training set details.

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