(111 days)
The Cortex Dental Implant System is indicated for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.
The Cortex Dental Implant System includes an integral array of devices comprising mainly of dental implants, abutments, additional prosthetic and surgical components, post surgical components, and surgical instruments.
This submission (K090709) is for a dental implant system, not an AI device. As such, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (like those involving test sets, expert ground truth, MRMC studies, or standalone algorithm performance) are not relevant here.
The "performance" section of the document instead focuses on mechanical strength testing and material processing validation for the physical implant device.
Here's a breakdown of the relevant information from the provided text, adapted to the nature of this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Guideline) | Reported Device Performance |
|---|---|
| FDA "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" (for mechanical strength) | Mechanical strength testing performed according to the FDA guidance document. Test results show that the implant/abutment combination is "highly resistant" (representing the most vulnerable system configuration/worst case). |
| ASTM B 600-91 (for Acid Treatment Process) | The Acid Treatment Process was designed in compliance with the guidelines of ASTM B 600-91. SEM-EDS results demonstrated that the process "saves the morphology of the surface." Process validation also verified that the implant surface is "cleaned from all alumina residuals and washing detergents used during the machining and alumina blasting." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in terms typically used for digital data (e.g., number of images, patient cases). For mechanical testing, this would refer to the number of physical implant units tested. The document mentions "The specimen tested represents the most vulnerable system configuration (worst case)," implying at least one (or a representative set) of this 'worst-case' configuration was tested.
- Data Provenance: Not applicable in the context of digital data. The testing was performed on physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is not an AI/ML device requiring expert-labeled ground truth for digital data. Mechanical and material properties are typically evaluated against established engineering standards by qualified engineers or lab personnel.
4. Adjudication method for the test set
- Not applicable. Evaluation of mechanical and material properties is typically objective, based on measurements and adherence to specifications, rather than expert adjudication of subjective assessments.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical strength: The "ground truth" is defined by the acceptance criteria specified in the FDA's "Class II Special Controls Guidance Document" for root-form endosseous dental implants. This guidance sets the objective performance thresholds for strength and durability.
- For the Acid Treatment Process: The "ground truth" is adherence to ASTM B 600-91 guidelines and objective scientific evidence (SEM-EDS results) confirming surface morphology preservation and cleaning efficacy.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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.