(105 days)
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.
Nobel Biocare's NobelActive 3.0 is an endosseous dental implant and abutment system. The implant is 3.0 mm diameter and available in lengths from 10.0 mm to 15 mm. Implants are made from CP titanium. Healing, temporary, and final abultnents are included in the system. Abutments are made from titanium vanadium alloy.
The provided text describes a 510(k) summary for the NobelActive 3.0 dental implant and abutment system. This regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and ground truth.
Based on the provided information, here's a breakdown of the requested elements:
1. Acceptance Criteria and Reported Device Performance
The document states that "Non-clinical test data was used to support the decision of safety and effectiveness." Specifically, fatigue testing was performed.
| Criterion | Reported Device Performance |
|---|---|
| Fatigue strength (in accordance with FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments) | "The testing indicates that the device is strong enough to withstand the anticipated forces." |
This is a rather general statement of performance, as specific quantitative acceptance criteria and the exact results are not provided in this summary. The primary "performance" demonstrated for regulatory purposes is substantial equivalence to the predicate device in terms of design, material, and indications for use, as outlined in the "Substantial Equivalence Comparison to Predicate Devices" table.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Non-clinical test data was used...". This implies laboratory testing rather than human subject data. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) is not directly applicable.
- Sample Size: Not specified for the fatigue testing.
- Data Provenance: Not applicable in the context of a clinical test set; these are non-clinical lab test results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable as the testing described is non-clinical (fatigue testing). Ground truth, in the context of expert review, typically refers to human-interpreted clinical data.
4. Adjudication Method for the Test Set
This question is not applicable as the testing described is non-clinical (fatigue testing). Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not performed. The submission relies on non-clinical testing and substantial equivalence to a predicate device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical dental implant, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is irrelevant here.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical fatigue testing would be the physical properties and failure characteristics of the NobelActive 3.0 implants under controlled laboratory conditions, assessed against established engineering standards (FDA guidance Class II Special Controls Guidance Document).
8. Sample Size for the Training Set
Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the traditional sense. The design and manufacturing process would be informed by engineering principles, material science, and previous product development, but not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set exists for this type of device.
§ 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.