(249 days)
This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both.
The Leibinger® IMF Screw is 2.0 mm in diameter and ranges from 10.5-18.5 mm in total length (6-14 mm in threaded length). There is a hole in the screw head through which a wire can be passed to fix the maxilla and mandible. The device is for single use only.
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or details about ground truth establishment.
The document is a 510(k) premarket notification letter from the FDA to Howmedica Leibinger, Inc. regarding their Leibinger IMF Screw. It confirms the substantial equivalence of the device to legally marketed predicate devices. It lists the device's proprietary name, common name, classification, and manufacturing details. It also mentions the basis for equivalence (similarities in intended use, material, design, and operational principle to other existing devices).
Therefore, I cannot provide the requested table and study 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.