Search Results

The CMI Implant IS II active is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Neo CMI Implant IS II active system is dental implant consist of pure titanium, grade 4. The titanium implant surface was sandblasted with large grits and acid etched (S.L.A.) This implant system can be used for all oral endosteal implant indications in the mandible and maxilla, for functional and esthetic oral rehabilitation of edentulous. The fixture diameters are 3.8, 4.3, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 and the lengths are 7.3, 8.5, 10.0, 11.5, 13.0, and 15.0.

This is not an AI/ML device and therefore the acceptance criteria and related study information are not applicable. The provided document is a 510(k) premarket notification for a dental implant, the CMI Implant IS II active, seeking substantial equivalence to a predicate device. The information details the device characteristics and comparison to the predicate, focusing on mechanical and material properties rather than AI/ML performance metrics.

Reasoning for Inapplicability:

The document describes a physical medical device (dental implant) that does not incorporate artificial intelligence or machine learning. The "Non Clinical Study Data" section refers to a "Static Compressive Load Test Data," which is a standard engineering test for mechanical strength, not an AI/ML performance study. The comparison criteria listed (product name, 510(k), manufacturer, shape, intended use, material composition, device design, surface treatment, biocompatibility, sterilization) are all related to the physical and biological characteristics of the implant, not to any AI/ML algorithm's performance.

Therefore, the requested details regarding acceptance criteria for AI/ML models, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not present in this document and are not relevant to this type of medical device submission.

Ask a specific question about this device