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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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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.

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.

The provided document is a 510(k) summary for a dental implant system (NSI Hexed and Non-Hexed Implant System). It explicitly states that "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." Therefore, there is no information available in this document regarding acceptance criteria or a study proving device performance against such criteria.

The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and intended use, rather than on new clinical performance data.

Consequently, I cannot provide the requested information, which includes:

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. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

Ask a specific question about this device