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The NB 1 SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB 1 SA Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

An endosseous dental implant is a device made of a material such as Pure titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The system includes NB I Fixture, Cover Screw, Healing Abutment, Cemented Abutment, and Abutment Screw.

This document describes the NB 1 SA Implant System, an endosseous dental implant. However, the provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data related to an AI/algorithm-based device.

The document is a 510(k) premarket notification for a medical device (dental implants). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, largely by highlighting that the subject device has the same fundamental scientific technology, principle of operation, general shape, functions, diameter, and material as the predicate. The "differences" noted are primarily changes in product name or minor design aspects (like a screw hole in the healing abutment) that the manufacturer argues do not impact substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text pertains to a dental implant system and not an AI/algorithm-based medical device. There is no mention of AI, algorithms, performance metrics like sensitivity/specificity, or clinical study designs involving human readers or standalone algorithm performance.

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