(204 days)
The Nobel Biocare's Brånemark System® DEC 600 Drilling Unit is intended to be used in oral and maxillo facial surgery including placement of the Branemark System endosseous implants. It is intended to be used to drill into the upper or lower jaw to prepare placement of an endosseous fixture, in the treading and mounting of fixtures, while drilling measure and record torque resistance for bone quality, as well as to tighten cover and abutment screws.
The Nobel Biocare Branemark System® DEC 600 Drilling Unit is intended for use in oral and maxillofacial surgery including preparing sites for implantation of an endosseous implant fixture.
The provided text is a 510(k) summary for the Nobel Biocare Branemark System® DEC 600 Drilling Unit. It does not contain information related to acceptance criteria or a study proving the device meets acceptance criteria in the context of an algorithm or AI system. Instead, it describes a medical device used in oral surgery and its substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer the questions as the required information is not present in the provided document.
To be able to answer your request, the input text would need to describe:
- Specific performance metrics and their target values (acceptance criteria).
- Details of a study (clinical trial, bench testing, etc.) that evaluated these metrics.
- Information about data sets, ground truth establishment, expert involvement, and study design.
§ 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.