Search Results

Nucleoss T6 Dental Implants are intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function. Nucleoss T6 Dental Implants are intended for delayed loading after 12 weeks.

Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures for edentulous or partially edentulous patients.

The Nucleoss T6 Dental Implant is a bone level implant constructed of unalloyed titanium (ISO 5832-2). The surface of the T6 implant is a sand-blast and acid-etch (SLA) surface treatment.

T6 Implants: Nucleoss T6 implants have a cylindrical form design, with a double lead thread form and two helical anti-rotation grooves. The thread structure is a reverse buttress. The internal structure is designed as a conical internal hex connection with 140 degrees.

The Nucleoss Dental Abutments are intended for use with the Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Abutments: The Nucleoss Dental Abutments consist of the following designs: Standard Straight, Esthetic Straight, Esthetic Angled, Ball and Equator, Cover, Gingiva Former and Screw. Nucleoss Dental Abutments are cement-retained and screw-retained restorations and intended for placement on Nucleoss T6 implants with diameters of 3.5, 4.1 and 4.8 mm. The connection to the dental implant is achieved by an internal hexagon. These devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.

Covers and Gingiva Formers: The Nucleoss Cover and Gingiva Former are used during the healing and prosthesis period following surgical placement of the dental implant. All of these devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.

Screws: The Nucleoss Dental Implant and Abutments devices also include screws for securing abutments to the implant to provide a secure coupling for the denture prosthetic attachment to the abutment.

The provided text is a 510(k) Summary for the Nucleoss T6 Dental Implant System. It details the device, its indications for use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study proving that an AI/Machine Learning device meets specific performance criteria. The entire document focuses on a dental implant system, which is a physical medical device, and the testing described (pull-out, fatigue, sterilization, accelerated aging, biocompatibility) are all standard engineering and material science tests for such a device. There is no mention of an algorithm, AI, machine learning, or any form of digital image analysis.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria or performance from this document. The questions about sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are relevant only for AI/ML device studies, which are not described in this submission.

Ask a specific question about this device