(142 days)
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
The provided text describes the regulatory clearance of a dental abutment, not an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" of the Elos Accurate® Customized Abutment to previously cleared predicate devices. The non-clinical testing described is for the physical dental device itself (e.g., fatigue testing, biocompatibility, sterilization validation) and validation of the digital dentistry workflow for designing and manufacturing the abutment.
There is no mention of:
- Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
- A test set, training set, or data provenance for an AI/ML algorithm.
- Experts establishing ground truth for AI/ML performance.
- Adjudication methods for AI/ML.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Ground truth types related to AI/ML (e.g., pathology for image classification).
The "digital dentistry workflow validation" mentioned refers to the software (3Shape Abutment Designer Software) that provides design limits for the abutment, not an AI/ML algorithm that performs a diagnostic or predictive task. It essentially ensures the software's constraints prevent users from designing abutments outside safe parameters.
Therefore, I cannot extract the requested information about AI/ML device acceptance criteria and study details from the provided document. The document is for a traditional medical device (dental abutment) and its manufacturing workflow, not an AI/ML enabled 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.)