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The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.

The OT Equator abutments are indicated for use with the following implant systems: (list of compatible implant systems follows)

The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial denture retained in whole or in part by endosseous implants in the mandibula or maxilla. The device is intended for use in healthcare facilities/hospitals.

The sphere OT Equator technology represents a prosthetic abutment solution for "overdenture". The emerging profile, specifically designed to accommodate the relative interchangeable copings OT Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation.

The abutments are for straight use only and are recommended for placement on straight implant bodies with no divergence or need for angle corrections.

The OT Equator is manufactured of titanium Ti-6Al-4V (meets ASTM Standard F-136) and it is designed to retain any prosthetic restoration.

The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the OT Equator dental implant abutment. It is a regulatory document and does not contain information about the acceptance criteria or study performance of an AI/ML device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study effect size
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence of the OT Equator device to previously cleared predicate devices based on materials, design, intended use, and manufacturing processes, rather than presenting a study related to an AI/ML device and its performance metrics. The non-clinical tests mentioned (biocompatibility, sterilization validation, reverse engineering analysis) are performed on the physical dental implant abutment and its interaction with implant systems, not on an AI system.

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