(590 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.