(270 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Validation of recommended drilling protocols | Implant (4.3x13 mm) fully seated in Type 3 bone surrogate at 55 N cm using 2.8/3.2 last drill. |
| Implant fully seated in Type 4 bone surrogate at 45 N cm using 2.4/2.8 last drill. | |
| Primary stability and micro-motion performance | Exhibited significantly less micro-motion than comparator devices in both 30 pcf (Type II to III) and 20 pcf (Type III to IV) bone surrogates (p ≤ 0.05). |
| Showed higher mechanical resistance to cyclic loads in a clinically relevant loading scenario. | |
| Clinical Performance: | |
| Achievable insertion torque for immediate loading | Mean insertion torque: 51.1 (SD 19.5) N cm in all bone qualities (healed sites). |
| Mean insertion torque: 46.15 (SD 17.5) N cm in predominantly cancellous bone (Type 3 and 4) (healed sites). | |
| Mean insertion torque: 47.21 (SD 11.4) N cm in all bone qualities (extraction sites). | |
| Mean insertion torque: 48.00 (SD 11.45) N cm in predominantly cancellous bone (Type 3 and 4) (extraction sites). | |
| Clinicians could reach high insertion torques, often in the 30-40 N cm range (for immediate loading in soft bone). | |
| Success/Survival Rate (especially in challenging bone qualities) | In healed and extraction sites (predominantly cancellous bone, Type III and IV): 97% successful after 3 years (out of 164 implants, 5 failed). |
| In healed sites: 96.8% successful. | |
| In extraction sites: 97.2% successful. | |
| In a separate prospective study (Irinakis and Wiebe, 2009): 2.1% failure rate (140 implants, 24 in soft bone) during observation period. | |
| In another study (Demanet et al, 2011): 99.1% total survival rate (466 implants), 98.3% in posterior maxilla (soft bone). | |
| Performance in soft bone (Type IV/posterior maxilla) | Irinakis and Wiebe (2009): Mean insertion torque of 47.9 N cm in soft bone (similar to medium bone). |
| Demanet et al (2011): 98.3% survival rate in posterior maxilla. |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.