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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 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 text describes a 510(k) premarket notification for the KOG1169 Endosseous Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on establishing performance criteria through clinical studies.

Therefore, many of the requested details about acceptance criteria, specific device performance, clinical study design, and ground truth establishment are not applicable or available in this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A): This submission is for an Endosseous Dental Implant System, and the document explicitly states, "FDA has not established a performance standard applicable to endosseous implants and their accessories." The submission relies on demonstrating substantial equivalence to predicate devices and meeting applicable voluntary standards for materials (ASTM F67-95 Grade III or Grade IV Titanium), sterilization, and packaging. The document does not provide specific quantitative performance metrics beyond these material and process standards.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable (N/A): No test set, in the context of an AI/algorithm performance study, was used or described. The submission is for a physical medical device (dental implant).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable (N/A): As no test set for an AI/algorithm was used, no ground truth experts were involved in this context.

4. Adjudication Method for the Test Set

Not Applicable (N/A): No adjudication method was involved as this is not an AI/algorithm performance study.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not Applicable (N/A): No MRMC study was conducted. The device is a physical dental implant, not an AI-assisted diagnostic tool. The document explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."

6. Standalone (Algorithm Only) Performance Study

Not Applicable (N/A): No standalone algorithm performance study was done as the device is a physical dental implant.

7. Type of Ground Truth Used

Not Applicable (N/A): As this is a submission for a physical device, not an AI/algorithm, the concept of "ground truth" in the context of diagnostic accuracy is not directly relevant. The assessment of the device's characteristics relies on compliance with material specifications (ASTM F67-95 Grade III or Grade IV Titanium) and validated sterilization and packaging methods (ISO, ASTM, EN standards).

8. Sample Size for the Training Set

Not Applicable (N/A): No training set was used as this is not an AI/algorithm submission.

9. How the Ground Truth for the Training Set Was Established

Not Applicable (N/A): No training set was used or ground truth established in this context.

Summary of Acceptance Criteria and Study:

Instead of typical AI/algorithm acceptance criteria and studies, this 510(k) submission demonstrates compliance by meeting material, sterilization, and packaging standards and demonstrating substantial equivalence to existing predicate devices.

Acceptance Criteria (based on compliance requirements):

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) involves:

• Conformance to Voluntary Standards: Explicitly stating that materials meet ASTM standards and sterilization/packaging processes are validated according to a comprehensive set of ISO, AAMI, ASTM, and EN standards.
• Predicate Device Comparison: A direct comparison of the technological characteristics and intended use of the new implants and accessories with a list of previously cleared predicate devices (K003620, K020617, K033171, K052490, K053478 NSI systems, and several Straumann Implant Systems K894595, K955281, K012757, K013798, K990342, K962023). The conclusion drawn is that the new components are substantially equivalent.
• Declaration of No Clinical Studies Needed: The submission explicitly states, "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission," indicating that the justification for safety and effectiveness is based on the substantial equivalence argument and adherence to recognized standards, rather than new clinical data.

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