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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.

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