Search Results

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

The Biomate Dental Implant System consists of Bone Type Implant Plus, Shaping Abutment and Healing Abutment. The Biomate Dental Implant System is made of commercial pure titanium (ASTM F67, Grade 4). Threaded dental implants are with Precision Dimension Laser (PDLTM) surface treatment, while Shaping Abutment and Healing Abutment are with TiN coated surface treatment. The device is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to replace missing teeth.

The provided text is a 510(k) premarket notification for a medical device (Biomate Dental Implant System). This type of document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing. It does not describe a study involving an AI algorithm or human reader performance. Therefore, I cannot provide information on acceptance criteria and studies related to AI performance from this document.

The document discusses traditional medical device validation through non-clinical performance tests, and states that "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

To answer your request, I would need a document describing a study for an AI-powered medical device.

Ask a specific question about this device