(104 days)
Premier Implant Cement™ is a non-eugenol temporary cement for luting implant-retained crowns.
Not Found
This appears to be an FDA 510(k) clearance letter for a dental cement, not a study report for an AI/ML medical device.
Therefore, I cannot extract the information requested about acceptance criteria and a study proving device performance in the context of an AI/ML product. The document describes the regulatory clearance of a traditional medical device (dental cement) based on substantial equivalence to a predicate device, as opposed to performance criteria demonstrated through a clinical study for an AI algorithm.
The questions you've asked are highly specific to the evaluation of AI/ML-based medical devices, which require different types of studies and performance metrics than the 510(k) clearance process outlined for this dental cement.
To answer your request, I would need a document describing a clinical study or validation report for an AI/ML medical device, not a 510(k) clearance letter for a conventional device.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.