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The SQ EB System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Smaller (e 3.5, o 4.0, o 5.0) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (e 6.0, e 7.0, e 8.0) implants are dedicated for the molar region and not indicated for immediate loading.

The SQ EB System is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance characteristics. EB System is made from pure titanium and the surface treatment is done with R.B.M.

This document is a 510(k) summary for a dental implant system (SQ EB System) seeking FDA clearance. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a premarket notification for substantial equivalence, not a performance study report for an AI/CADe device.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, indications, and intended use, rather than presenting a detailed performance study with acceptance criteria for a new AI/CADe device.

The information sought, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, are typically found in documents related to the evaluation of AI/CADe products, which rely on defined metrics and clinical performance data. This document describes a traditional medical device, a dental implant, and not an AI-powered one.

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