(286 days)
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.
The subject Novaloc TiN Abutments are intended to be placed onto Straumann dental implants to provide support for full or partial arch detachable restorations (over-denture). The coronal portion of the subject abutments are similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann Dental Implant System. The Novaloc abutments are manufactured from TAV (Ti-6AI-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject Novaloc TiN Abutments are provided in straight and anqulated models, in different heights. The subject Novaloc TiN Abutment is also provided in a bar attachment. The Novaloc TiN abutments are provided non-sterile with instructions for end user sterilization.
The provided text describes a 510(k) premarket notification for dental implant abutments, focusing on the substantial equivalence of the new device to existing predicate devices. However, it does not contain information about a study that proves a device meets specific acceptance criteria related to a machine learning or AI-driven medical device, nor does it include details about ground truth establishment, expert adjudication, or MRMC studies, which are characteristic of AI/ML device evaluations.
The document is purely a regulatory submission for a physical medical device (dental abutments) and focuses on engineering and biocompatibility testing for substantial equivalence, not performance criteria for diagnostic or algorithmic accuracy.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document refers to "Performance Testing" for the dental abutments, but this is in the context of mechanical, sterilization, and biocompatibility testing, not AI/ML performance.
To answer your request, I would need a document describing the evaluation of an AI/ML medical device.
§ 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.)