(46 days)
The Ortho Anchor Screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.
The MIS Ortho Anchor Screws are self-tapping screws that are used as fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. The screw is manufactured as one piece screw made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The upper head of the screw has a cross-hole through which a wire can pass to fix the mandible and maxilla in the orthodontic procedure. The screw head is special designed to assist the use of orthodontic appliances. The Ortho Anchor Screws are provided in several lengths ranging between 5-10mm and diameters of 1.4mm, 1.6mm and 2mm. The screws are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are supplied sterile.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a 510(k) summary for Ortho Anchor Screws, which primarily focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies on showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
§ 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.