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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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI MAX Implant System is intended for implantation in the maxilla or mandibular molar region where bone exists and the surgeon has determined a wider implant would increase the probability of placement of a narrow implant, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It also adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

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 loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The provided document is a 510(k) premarket notification for an Endosseous Dental Implant System. It does not describe acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence of a dental implant system to previously marketed predicate devices. Key aspects covered are:

• Device Description and Intended Use: The NSI Implant System for supporting dental prostheses in the upper or lower jaw, with an option for immediate loading.
• Performance Standards: There is no FDA performance standard for endosseous implants. The materials used meet applicable voluntary standards (ASTM F67-95 Grade III or IV Titanium).
• Sterilization Methods: Achieved using Co60 irradiation, validated against ISO 11137, ISO 11737-2, and ISO 13409.
• Packaging Method and Validation: Packaging involves plastic tubing, blister packs, and clear plastic boxes, validated against various ASTM, EN, and ISO standards related to performance testing, seal strength, leak detection, accelerated aging, and general requirements for sterile medical device packaging.
• Technological Characteristics: Compared with predicate devices and found to be comparable.
• Surface Modifications: Blasted with 100 micron alumina particles, with visual inspection and SEM testing.
• Clinical Studies: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." This explicitly states that no clinical performance study was performed or considered necessary to establish substantial equivalence for this particular submission.

Therefore, since the request is about an AI-powered device and the provided document describes a physical medical device (dental implant) and explicitly states no clinical studies were conducted, I cannot provide the requested information about acceptance criteria and a study proving an AI device's performance based on this document.

The document does not contain any information about:

• Acceptance criteria for an AI device.
• Reported device performance for an AI device.
• Sample size for a test set or data provenance for an AI device.
• Number of experts or their qualifications for establishing ground truth for an AI device.
• Adjudication methods for an AI device's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone AI algorithm performance.
• Type of ground truth used for AI.
• Sample size or ground truth establishment for a training set for AI.

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