(30 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 imolants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures. In the edentulous mandible, the XiVE® dental implants are indicated for immediate loading procedures using the standard protocol.
The provided document is a 510(k) summary for the FRIADENT GmbH XIVE® Dental Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria via a clinical study with an AI component. Therefore, much of the requested information regarding AI device evaluation is not applicable to this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics against such criteria in the way a clinical study for an AI device would. The core of this 510(k) is to demonstrate "substantial equivalence." The "performance evaluations" mentioned are general and refer to the device performing "as intended," not against specific numerical thresholds.
| Acceptance Criteria (Not Explicitly Stated for this 510(k)) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| (Implicit) Substantial Equivalence to Predicate Devices | The device is substantially equivalent to the predicate devices in terms of design, materials, mechanical strength, prosthetic and laboratory options, and intended use. |
| (Implicit) Performs as Intended | "Performance evaluations of the XiVE® dental implant system show that the device performs as intended." |
| (Implicit) Biocompatibility / Safety (as per predicate) | Constructed of CP-2 titanium, which is consistent with existing cleared devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI device. The comparison is primarily based on technological characteristics and intended use relative to predicate devices. The "performance evaluations" mentioned are not detailed as a specific study with a quantifiable sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This submission does not involve AI model development or ground truth establishment by experts in the context of a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set or adjudication for an AI device.
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 device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no AI model requiring ground truth. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI device or training set.
Summary based on the provided document:
The K032158 submission for the XiVE® Dental Implant System focuses on demonstrating substantial equivalence to previously cleared predicate devices (K013867 and K021318). The primary argument for equivalence is that the device has the same design, materials (CP-2 titanium), mechanical strength, prosthetic options, instructions for use, and intended use as the predicate devices. The only stated difference is a change in the surface morphology to the "FRIADENT Surface M2.1." The submission asserts that "Performance evaluations of the XiVE® dental implant system show that the device performs as intended." This implies that internal testing or existing knowledge about the materials and design support its function, but no detailed study or specific quantitative acceptance criteria are provided in this summary. The FDA's clearance letter confirms their agreement that the device is substantially equivalent to the predicate.
§ 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.