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The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

The NobelActive 3.0 GoldAdapt Abutment is an abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of a gold alloy.

The provided text describes a 510(k) submission for a dental abutment. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical or standalone performance studies with specific acceptance criteria as you've outlined for AI/software devices.

Therefore, many of the requested categories (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this document. The "device performance" in this context refers to non-clinical fatigue testing to ensure the device's mechanical strength is adequate and comparable to predicates.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for a traditional AI/software device evaluation:

1. A table of acceptance criteria and the 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)

• Sample Size: Not specified. This typically refers to the number of physical abutments subjected to fatigue testing.
• Data Provenance: Not applicable in the context of clinical data for this type of device. The testing is non-clinical/mechanical.

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. This is a non-clinical, mechanical device. "Ground truth" would refer to the physical properties and performance measured during fatigue testing, not expert interpretation.

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

• Not Applicable. This is a non-clinical, mechanical device. Adjudication methods are typically used for expert review of clinical cases.

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

• No. The document explicitly states: "No clinical testing was performed." MRMC studies apply to AI-assisted diagnostic tools involving human readers.

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

• Not Applicable. This is a physical, non-AI dental abutment.

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

• Not Applicable. The "ground truth" for this device's performance is determined by the physical results of fatigue testing, measured against established engineering standards (e.g., ability to withstand anticipated forces, as outlined in FDA guidance for dental implants).

8. The sample size for the training set

• Not Applicable. This is a non-AI, physical medical device. There is no training set as would be found in machine learning.

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

• Not Applicable. This is a non-AI, physical medical device. There is no training set or ground truth establishment relevant to AI/software development.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets its (implicit) acceptance criteria is a non-clinical fatigue testing study.

• Methodology: The testing was conducted "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance outlines the specific mechanical tests and acceptance criteria for demonstrating the durability and strength of such devices.
• Results: The testing indicated "that the device is strong enough to withstand the anticipated forces."
• Conclusion: Based on this non-clinical data, the device was deemed "substantially equivalent" to predicate devices, satisfying the requirements for 510(k) clearance by demonstrating comparable safety and effectiveness, particularly in terms of mechanical integrity.

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