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The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

The parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.

The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON® Tissue Level and Bone Level is polished.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

Subject to this submission are the following implant variations:

BL NC Ø3.75 mm, L 8 mm BL NC Ø3.75 mm, L 10 mm BL NC Ø3.75 mm, L 12 mm

TL RP Ø3.75 mm, L 8 mm TL RP Ø3.75 mm, L 10 mm TL RP Ø3.75 mm, L 12 mm

TL RP Conical Ø4.1 mm, L 10 mm

The provided text is a 510(k) summary for a medical device (Dental Implants OKTAGON® Tissue Level and Bone Level). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of algorithm performance for an AI/ML powered device. The "performance tests" mentioned refer to fatigue tests against ISO 14801 for mechanical properties of dental implants, not AI/ML algorithm evaluation.

Therefore, I cannot extract the requested information as it does not exist within the provided document.

To be explicit, the following information is not present in the document:

• A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (for an AI/ML algorithm).
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to the regulatory submission for a physical medical device (dental implants), not a software-as-a-medical-device (SaMD) or an AI/ML-powered medical device.

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