(85 days)
Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's Adapter PS is an implant/abutment system adapter. The Adapter PS allows a Nobel Biocare internal tri-lobe implant to be used with a hexed external connection abutment. The Adapter PS allows a narrow platform hexed abutment to be used on a regular platform internal tri-lobe implant and a regular platform hex abulment to be used on a wide platform internal tri-lobe implant. The Adapter PS may only be used with the implants and abutments listed in the Instructions For Use.
The provided document is a 510(k) summary for the Nobel Biocare Adapter PS, which describes an implant/abutment system adapter. This type of document is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, the document does not contain any information regarding:
- A table of acceptance criteria and reported device performance: This document does not describe performance metrics or criteria that the device had to meet through testing.
- Sample size used for the test set and data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment or expert involvement is mentioned for performance evaluation.
- Adjudication method for the test set: Not applicable as no test set is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (algorithm-only) performance: This device is a physical dental component, not a software algorithm.
- Type of ground truth used: Not applicable as there's no performance study described.
- Sample size for the training set: Not applicable as there's no machine learning algorithm or training set.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory clearance for a dental device based on substantial equivalence and does not detail a study that proves the device meets specific performance acceptance criteria. It primarily focuses on the device description, indications for use, and a comparison to predicate devices for regulatory purposes.
§ 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.)