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The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended for implantation in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multipleunit implant restorations anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The provided 510(k) summary for the NSI Hexed and Non-Hexed Implant System (K033171) explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."

Therefore, based on the provided document, the following information cannot be determined:

• Acceptance criteria
• Reported device performance
• Sample size used for the test set
• Data provenance
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study (effect size)
• Standalone performance study
• Type of ground truth used (for test set)
• Sample size for the training set
• How ground truth for the training set was established

The submission focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and expanding the intended use for immediate loading, rather than through clinical performance data.

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