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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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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.

This 510(k) submission (K053478) for the NSI Hexed and Non-Hexed Endosseous Implant System did not include a study or defined acceptance criteria related to device performance in an AI/software context. This submission is for an endosseous dental implant system, which is a physical medical device, not an AI or software-based device.

The "acceptance criteria" and "device performance" in this context refer to the physical and manufacturing properties of the dental implants, as well as their sterilization and packaging. There are no performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/software devices.

Here's a breakdown of the information provided in the context of a physical device submission:

1. A table of acceptance criteria and the reported device performance

The submission details specific standards that the device and its manufacturing processes meet, rather than specific numerical performance metrics in the way one would describe AI.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." Therefore, there is no "test set" in the context of clinical performance data or AI evaluation. The "data" refers to the results of testing against the physical/manufacturing standards mentioned in point 1. These tests are typically performed in a laboratory setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As no clinical studies or AI evaluations were conducted, there was no need for experts to establish ground truth in this context. The "ground truth" for the physical device relates to its adherence to material, manufacturing, sterilization, and packaging standards, which are verified through established engineering and quality control procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical studies or AI evaluations were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a physical dental implant, not an AI or imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable (in the AI/clinical sense). The "ground truth" for this device's acceptance is its compliance with established engineering, material, sterilization, and packaging standards (e.g., ASTM, ISO standards) and its substantial equivalence to predicate devices. This is verified through laboratory testing and documentation, not clinical outcomes or expert consensus on interpretations of data.

8. The sample size for the training set

• Not Applicable. No AI or machine learning model was developed or trained for this device.

9. How the ground truth for the training set was established

• Not Applicable. As no AI training occurred, no ground truth for a training set was established.

Summary:

This 510(k) submission is for a physical medical device (dental implants). The "acceptance criteria" and "study" described in the document relate to the manufacturing process, materials, sterilization, and packaging of the implants, rather than clinical performance studies or AI/software validation. The claim for substantial equivalence is based on the device's similar technological characteristics and intended use to legally marketed predicate devices, and its compliance with relevant voluntary industry standards for materials, sterilization validation, and packaging. No clinical studies were conducted or deemed necessary for this particular submission.

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

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

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

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

The provided text is a 510(k) Premarket Notification Summary for an Endosseous Dental Implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design with sample sizes, expert ground truth, MRMC studies) are not applicable in this context. The document explicitly states that "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."

However, I can extract information related to what was conducted and what the overall conclusion implies regarding its "acceptance."

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A: Clinical studies were not conducted. The "test set" for this submission primarily consisted of the engineering tests (fatigue and torsion) performed on the new device iterations. The sample size for these engineering tests is not specified in this summary. Data provenance is not applicable as there are no human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A: Clinical studies were not conducted, so there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission. For the engineering tests, the "ground truth" is established by the accepted standards and protocols for mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A: No clinical studies were performed requiring adjudication of results from human subjects.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A: This is for an endosseous dental implant, not an AI-powered diagnostic device. No comparative effectiveness studies involving human readers or AI assistance were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A: This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the substantive equivalence claim: The "ground truth" is the established safety and effectiveness of the predicate devices and the accepted engineering standards (ASTM F67-95, FDA Class II Special Controls Guidance Document) for material and mechanical performance.
• For engineering studies: The "ground truth" is defined by the passing criteria of the specific fatigue and torsion tests, derived from the FDA guidance and discussions with the FDA.

8. The sample size for the training set

• N/A: No clinical studies were conducted, and this is not a machine learning device that requires a "training set."

9. How the ground truth for the training set was established

• N/A: No clinical studies were conducted, and this is not a machine learning device.

Ask a specific question about this device

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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