(345 days)
AR N SLA Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR_N SLA Type Implant System is for two stage surgical procedures. It is intended for delayed load.
The AR_N SLA Type Implant System is a dental implant system made of CP Ti Gr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with SLA(Sandblasted with Large-grit and Acid-etching). The AR N SLA Type Implant System is offered in the following sizes. Subject implant bodies are to be used only with all abutments cleared in the primary predicate submission, and the cover screw and abutment screw to be used are the same as cleared in the primary predicate.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a dental implant system (AR_N SLA Type Implant System). It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing (sterilization validation, surface characteristics, fatigue, biocompatibility, pyrogenicity, LAL bacterial endotoxin, and shelf life).
The text does not describe any study involving AI, human readers, or the establishment of ground truth by expert consensus, pathology, or outcomes data. Therefore, I cannot extract details regarding:
- Acceptance criteria for AI performance or reported device performance related to AI.
- Sample sizes for test sets in an AI context or data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication methods for test sets.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone (algorithm only) performance.
- Type of ground truth used in an AI study.
- Sample size for training sets.
- How ground truth for the training set was established.
The document is purely about the physical and material characteristics, manufacturing processes, and safety testing of a dental implant for FDA clearance, not about any AI-powered device or diagnostic tool.
§ 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.