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The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly The Zygonia Angled Abdamont is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prostherity in The Nobel Blocare Zygoma Angled Koathent is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic The Nobol Elocal o Eygoniant and is intended for use as an aid in prosthetic rehabilitation.

The Zygoma Angled Abutment is an artificial tooth abutment designed to fit and function on Nobel Biocare's Zygoma implant.

The provided text is a 510(k) summary for the "Zygoma Angled Abutments." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets specific performance metrics.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: The document does not specify any performance-based acceptance criteria or report performance data. It states the device "is intended to be used as a prosthetic component directly" and "is intended for use as an aid in prosthetic rehabilitation," but these are indications for use, not performance metrics.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method: No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI algorithm.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set ground truth is described.

The document's purpose is to establish substantial equivalence for market clearance, not to demonstrate performance against specific technical criteria through a detailed study summary.

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