(60 days)
The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.41.8mm in diameter and ranges from 513mm in total length. It is made of Titanium 6Al-4V alloy. There is a hole in the screw head with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
This 510(k) summary for K082838 does not contain the results of a study with specific acceptance criteria and device performance metrics. Instead, it demonstrates substantial equivalence to predicate devices (K050568, K052968, and K033767) based on similarities in device characteristics, material, design, and intended use.
Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance, sample size, data provenance, expert information, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.
The document explicitly states: "ORLUS Mini Screw has the same device characteristics, material, design and intended use as the predicate device." and concludes that it is "safe and effective and substantially equivalent to the predicate device as described herein." This indicates a comparison to existing devices rather than a new performance study with quantified 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.