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NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

NobelActive® implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive® 3.0 implants are indicated for single unit restorations only.

Nobel Biocare's NobelActive® implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.

Here's an analysis of the acceptance criteria and supporting studies for the NobelActive® dental implant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with clear thresholds for success (e.g., "must achieve X% success rate"). Instead, it describes performance benchmarks relative to existing devices and clinical expectations for dental implants.

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

• Bench Studies:

  • Drilling protocols: 1 implant (4.3x13 mm) tested in each of two bone surrogate types.
  • Primary stability and micro-motion: Not explicitly stated, but "different implant geometries and simulated bone densities" were used with "comparator devices." The number of implants per geometry/density is not provided.
  • Provenance: Not explicitly stated, but these are non-clinical (laboratory) studies.

• Clinical Studies:

  • Study 1 (Healed Sites): 199 NobelActive® implants.
  • Study 2 (Extraction Sites): 137 NobelActive® implants.
  • Study 3 (Implant Handling): 88 implants.
  • Study 4 (Irinakis and Wiebe, 2009): 140 implants.
  • Study 5 (Demanet et al, 2011): 466 implants.
  • Data Provenance: The document does not explicitly state the country of origin. Clinical studies are inherently prospective to some extent, but the reporting here is retrospective (summarizing past studies). The "Irinakis and Wiebe (2009) conducted a prospective study" explicitly states it was prospective. The other clinical data descriptions imply retrospective analysis of existing clinical data.

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

• Bench Studies: Ground truth is based on physical measurements and engineering principles. Experts (engineers, researchers) are involved in conducting and interpreting these tests, but their specific number or dental qualifications are not specified as they relate to the "ground truth" of implant performance in a lab setting.
• Clinical Studies:
  • Bone quality classification (Lekholm and Zarb) was done "by the treating surgeon" according to standard methods, including imaging, pre-surgical investigation, and tactile sensation.
  • "Four (4) clinicians" placed implants in the implant handling study.
  • The studies mentioned clinical investigators/treating surgeons for implant placement and follow-up. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. However, a "treating surgeon" or "clinician" implies medical/dental professionals experienced in implantology.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes or data interpretation. Clinical results are typically derived from direct observation and measurement on patients, with success/failure criteria defined within each study's protocol.

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

This document is for a dental implant (a physical device), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

As noted above, this submission is for a physical medical device (dental implant). It does not involve an algorithm or AI, so the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Bench Studies: Physical measurements (torque, micro-motion, seating depth) in simulated environments (bone surrogates).
• Clinical Studies:
  • Clinical outcomes: Implant success/failure rates, survival rates, insertion torque values, bone quality classification by the treating surgeon. This is essentially direct clinical observation and measurement of "real-world" performance in patients.

8. The Sample Size for the Training Set

This submission pertains to a physical dental implant, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/algorithms is not applicable. The clinical data described contributes to the overall evidence base for the device's performance, rather than serving as a training set for an algorithm.

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

Since this is not an AI/ML device, there is no "training set" and thus no ground truth established for one. The clinical studies mentioned contribute to demonstrating the device's safety and effectiveness for its intended use.

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