(68 days)
The XiVE Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.
The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading procedures using four implants in the anterior mandible.
The provided text describes a 510(k) premarket notification for the FRIADENT GmbH XiVE® Dental Implant System. This type of submission is for medical devices, not AI/ML algorithms, and therefore the information requested about acceptance criteria and study design for AI/ML performance metrics is not applicable to this document.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than establishing de novo performance criteria through extensive clinical trials as would be required for a novel AI/ML device.
Here's an analysis based on the provided text, highlighting why the requested AI/ML specific information cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in the sense of performance thresholds for an AI/ML algorithm (e.g., specific sensitivity, specificity, or AUC targets). Instead, the "performance" demonstrated is that the XiVE Dental Implant System is substantially equivalent to legally marketed predicate devices.
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance |
|---|---|
| Same intended use as predicate device | XiVE® Dental Implant System "is indicated as follows: once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XIVE dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement." (Matches predicate's intended use). |
| Similar technological characteristics to predicate device | "The XiVE® dental implant is identical to the current XiVE® Dental Implant System in terms of design, materials, coatings, prosthetic options and mechanical attributes. The XiVE® dental implant is substantially equivalent to the FRIADENT FRIALOC® Dental Implant System in terms of intended use." "The XiVE dental implant system was tested for compressive and static strength and finite element analysis." (These tests are to demonstrate similar characteristics, not AI performance). |
2. Sample size used for the test set and the data provenance
Not applicable for AI/ML performance. The submission relies on mechanical testing (compressive and static strength, finite element analysis) of the physical implant, which does not involve a "test set" of data in the AI/ML sense. No patient data provenance information is provided for these mechanical tests, as they are likely conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for AI/ML performance. No ground truth determination by experts for AI/ML performance is described.
4. Adjudication method for the test set
Not applicable for AI/ML performance. No adjudication method for AI/ML data is described.
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 device is a physical dental implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for a physical medical device typically relates to its material properties, biocompatibility, and mechanical performance. The document only mentions:
- Mechanical Testing: Compressive and static strength, and finite element analysis. These tests likely follow established industry standards to ensure the implant's durability and structural integrity.
- Substantial Equivalence: The primary "ground truth" from a regulatory perspective for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
8. The sample size for the training set
Not applicable for AI/ML performance. No training set for an AI/ML algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable for AI/ML performance. No ground truth for an AI/ML training set is mentioned.
In summary, the provided document pertains to a traditional physical medical device (dental implant) seeking 510(k) clearance based on substantial equivalence to existing devices, not an AI/ML powered device. Therefore, the specific criteria for evaluating AI/ML algorithm performance are entirely absent and not relevant to this submission.
§ 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.