(15 days)
"0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw surgically praced in the bone of the or still devices resulting arches providing bart the patient's chewing function.
OCO Dental Implant (3.25mm diameter)
I apologize, but the provided text from the FDA 510(k) summary for the "OCO Dental Implant" does not contain information about acceptance criteria, device performance metrics, or details of a study involving AI or human readers.
The document is a traditional 510(k) clearance letter confirming that the device is substantially equivalent to a predicate device for its stated indications for use. It primarily focuses on regulatory compliance and does not include the type of performance study data that would be relevant to AI-based medical devices or even detailed clinical performance data for traditional devices beyond what is necessary to establish substantial equivalence.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)