(105 days)
Implants: OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended.
Prosthetic Abutments, Cover Screws & Healing Abutments: OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.
The OsseoLink Dental Implant System is an endosseous type artificial tooth replacement system that is intended for use in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.
The provided text is a 510(k) summary for the OsseoLink Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.
The document states:
"It has been shown in this 510(k) submission that the differences between the OsseoLink Dental Implant System and the predicate devices do not raise any questions regarding its safety and effectiveness. The OsseoLink system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices."
This indicates that the submission relies on demonstrating similarity to already approved devices rather than presenting a performance study with acceptance criteria for a new, distinct performance claim.
Therefore, I cannot provide the requested table and study details because the information is not present in the provided document. The 510(k) summary is for a dental implant system, which is a physical device, not an AI or algorithm-based device that would typically have the kind of performance metrics and study designs you've asked about (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance).
§ 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.