Search Results
Found 1 results
510(k) Data Aggregation
(204 days)
The Nobel Biocare's Brånemark System® DEC 600 Drilling Unit is intended to be used in oral and maxillo facial surgery including placement of the Branemark System endosseous implants. It is intended to be used to drill into the upper or lower jaw to prepare placement of an endosseous fixture, in the treading and mounting of fixtures, while drilling measure and record torque resistance for bone quality, as well as to tighten cover and abutment screws.
The Nobel Biocare Branemark System® DEC 600 Drilling Unit is intended for use in oral and maxillofacial surgery including preparing sites for implantation of an endosseous implant fixture.
The provided text is a 510(k) summary for the Nobel Biocare Branemark System® DEC 600 Drilling Unit. It does not contain information related to acceptance criteria or a study proving the device meets acceptance criteria in the context of an algorithm or AI system. Instead, it describes a medical device used in oral surgery and its substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer the questions as the required information is not present in the provided document.
To be able to answer your request, the input text would need to describe:
- Specific performance metrics and their target values (acceptance criteria).
- Details of a study (clinical trial, bench testing, etc.) that evaluated these metrics.
- Information about data sets, ground truth establishment, expert involvement, and study design.
Ask a specific question about this device
Page 1 of 1