(77 days)
The Sistema de Implante Nacional Dental Implant System is intended to be surqically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Restorations supported by two or more Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.
Sistema de Implante Nacional Dental Implants are threaded, tapered and straight endosseous dental implants made of commercially pure titanium and intended for use with Sistema de Implante Nacional System abutments and instruments. The implants are offered in a multiple of lengths and diameters. They are offered with a machined surface or acid etched.
The provided text describes a 510(k) premarket notification for a dental implant system. It outlines the device's classification, intended use, and equivalence to existing devices. However, the document does not contain information related to specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
Therefore, it is impossible to complete the requested table and provide the detailed study information based on the given input.
Reasoning for missing information:
- Acceptance Criteria & Reported Performance: The document states that "No performance standards applicable to endosseous dental implants have been established by FDA." It mentions that the CP titanium used meets ASTM F 67 and ISO 5832-2, which are material specifications, not device-level performance criteria for the implant system itself. No reported device performance data against specific acceptance criteria is present.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): The document is a regulatory submission for substantial equivalence. It does not describe any specific clinical or non-clinical studies conducted to prove device performance against acceptance criteria. There's no mention of a test set, training set, or how ground truth was established by experts.
- Ground Truth Type: Since no studies are described, there is no information on the type of ground truth used.
- Training Set Sample Size: No training set is mentioned as no algorithm or AI component is described.
- Ground Truth for Training Set: Not applicable as no training set is mentioned.
The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with specific acceptance criteria that would be typical for a novel device or a device incorporating advanced AI/ML components.
§ 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.