(84 days)
Super Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
The Super Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.6 and 1.8 mm in screw diameter and 6, 8, 10, 12mm in length. It is made of Titanium 6AI-4V alloy(ASTM F 136-98). The surface of the screw is non-treated and that of head is TiN coated. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. It is supplied non-sterile and must be sterilized prior to use by Steam heat sterilization.
The provided document for K062156, Osstem Implant Co., Ltd.'s "Super Orthodontic Screw," does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.
This 510(k) submission is a "premarket notification" that focuses on demonstrating "substantial equivalence" to predicate devices. It relies on a comparison of characteristics (material, design, use concept) and general safety, performance, and product validations, rather than specific performance metrics and dedicated studies with acceptance criteria as typically found in more recent device submissions or clinical trial reports.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, or ground truth for a performance study from this document.
However, I can extract the general claims made about the device's validation:
General Claims Regarding Validation:
"Super Orthodontic Screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations. An extensive review of literature pertaining to the safety and biocompatibility of Super Orthodontic Screw has been conducted. Appropriate safeguards have been incorporated in the design of Super Orthodontic Screw."
Without further documentation beyond this 510(k) summary, it's impossible to fulfill the request for detailed acceptance criteria and study information. This submission primarily serves to establish substantial equivalence based on general design, materials, and intended use, rather than presenting a detailed performance study against specific acceptance criteria.
§ 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.