(192 days)
Biodenta dental implants intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.
Specific indications for small diameter (Ø 3.5 mm) implants: It is recommended not to place small implants with "NP" platform in the molar or premolar region.
The BIODENTA Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the BIODENTA Dental Implant System:
Summary: The provided document is a 510(k) submission for the BIODENTA Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and materials. It does not contain information about formal acceptance criteria, a clinical study with performance metrics for the device itself, sample sizes, expert ground truth, or adjudication methods for this specific device's performance.
The document states: "The clinical data and the test results demonstrate that the BIODENTA Dental Implant System is as safe and effective as the legally marketed device Straumann AG, Implant System Standard Plus." and "Based on the risk analysis, performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed." However, it does not explicitly detail these "clinical data and test results" or the specific performance metrics and acceptance criteria used.
Therefore, the following sections will indicate where the requested information is Not Provided (N/P) in the supplied text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/P | N/P |
| (Specific performance metrics (e.g., success rates, failure modes, stability measurements, etc.) and their corresponding acceptance thresholds are not detailed in the provided summary.) | (The summary indicates the device is "as safe and effective" as predicate devices and that "all functions were verified to operate as designed," but no quantitative performance data is presented.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: N/P
- Data Provenance: N/P (No specific study details are provided, so provenance cannot be determined.)
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)
- Number of Experts: N/P
- Qualifications of Experts: N/P
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: N/P
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
- MRMC Study: No. This device is a dental implant system, not a diagnostic AI system, so an MRMC study comparing human readers with and without AI assistance is not applicable.
- Effect Size of Human Improvement with AI: N/A
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: No. This device is a dental implant system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: N/P (No specific studies with explicit ground truth methodologies are detailed for the BIODENTA system itself. The claim of "safe and effective" relies on equivalence to predicate devices, which would have had their own clinical data and outcomes.)
8. The sample size for the training set
- Sample Size for Training Set: N/P (This device is not an AI/ML algorithm requiring a training set.)
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: N/A (This device is not an AI/ML algorithm requiring a training set and ground truth establishment in that context.)
§ 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.