(165 days)
The XiVE 3.0 Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.
The XiVE 3.0 Dental Implant System consists of subgingival threaded dental implants with a 3.25mm diameter and lengths of 11 -- 15mm . 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 in the anterior regions of the mouth.
The provided text describes a 510(k) premarket notification for the FRIADENT GmbH XiVE® 3.0 Dental Implant System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for a novel AI/software medical device.
Therefore, many of the specific details requested regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods are not explicitly present in the provided text, as this type of information is typically not included in a 510(k) summary for a dental implant demonstrating substantial equivalence.
Here's an analysis based on the available information:
Description of Acceptance Criteria and Proving Device Meets Criteria
The document states: "Performance evaluations of the XiVE 3.0 dental implant system show that the device performs as intended for the anterior region of the mouth. Comparison of the XiVE 3.0 dental implant system to the predicate device show that the device is substantially equivalent."
This suggests that the "acceptance criteria" primarily revolved around demonstrating substantial equivalence to the predicate device in terms of design, materials, coatings, mechanical strength, prosthetic options, and intended use, as well as satisfactory performance for its intended use. The specific quantitative criteria for "performance as intended" are not elaborated.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (FRIALIT-2® 3.4mm Dental Implant System) in: | The XiVE® 3.0 dental implant is substantially equivalent to the FRIALIT-2® 3.4mm Dental Implant Systems in terms of design, materials, coatings, mechanical strength, prosthetic options and single tooth intended use. |
| - Design | (Implied to meet, as per substantial equivalence statement) |
| - Materials | Constructed of CP-2 titanium, identical to predicate in materials. |
| - Coatings | Coated with FRIOS Deep Profile Surface, identical to predicate in coatings. |
| - Mechanical Strength | Tested for compressive and static strength. (Specific results not provided but implied to meet) |
| - Prosthetic Options | Variety of prosthetic options (EstheticBase, AuroBase, Select, Telescopic Abutments), identical to predicate. |
| - Intended Use (single tooth replacement in anterior regions) | Performs as intended for the anterior region of the mouth. Indicated for single tooth restorations in the region of 7 to 10 and 23 to 26. |
| Finite Element Analysis (FEA) results | Finite element analysis performed. (Specific results not provided, but implied to meet) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document mentions "performance evaluations" and mechanical testing (compressive, static strength, finite element analysis) but does not provide numbers of devices tested or specific clinical data from a "test set."
- Data provenance: Not explicitly stated. The tests conducted (compressive, static strength, finite element analysis) are typically laboratory-based engineering tests rather than clinical trials with patient data.
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 a study requiring expert-established ground truth in the context of diagnostic interpretation (e.g., radiology). The "ground truth" for a dental implant would be its physical properties and mechanical performance.
4. Adjudication method for the test set
- Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
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 a dental implant, not an AI/software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a dental implant, not an algorithm.
7. The type of ground truth used
- The ground truth for a dental implant's performance would be derived from engineering specifications, material science standards, and mechanical testing results (e.g., strength, fatigue life, material composition). The document mentions "compressive and static strength and finite element analysis," which are methods to establish this type of ground truth.
8. The sample size for the training set
- Not applicable. This is a dental implant, not a machine learning model, so there is no "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.