(342 days)
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.
In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations .
In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant. Comprises two types of connections: Externa® and Interna® with a range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm) for various platforms, we refer to Table 5-1. BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.
The provided text describes the acceptance criteria and the study conducted for the BTI Dental Implant System UnicCa®. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative table for the clinical study. However, the reported device performance is:
| Attribute | Acceptance/Performance |
|---|---|
| Implant Survival | 99.5% (implant-based) at 6 months post-implant insertion |
| Patient/Subject Survival | 98.8% (subject-based) at 6 months post-implant insertion |
| Complications/Adverse Events | No complications or adverse events reported related to the use of BTI UnicCa implants |
The study implicitly aims to demonstrate that these survival rates are comparable to or exceed commonly observed rates in the literature (90% to 98%).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 170 patients with 430 BTI UnicCa implants.
- Data Provenance: Retrospective observational study. The country of origin of the data is not specified in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study is described as an "observational retrospective study," which typically involves reviewing existing patient records or clinical outcomes, rather than having experts establish ground truth for a new test set. The criteria for "implant survival" are defined (stable prosthesis, no pain, infections, pathology, absence of radiopaque images around implant, no loss/fracture/significant bone loss/infection), implying a clinical assessment standard.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
There is no indication of a Multi Reader Multi Case (MRMC) comparative effectiveness study or any involvement of AI in this document. The device is a dental implant, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a dental implant, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the clinical study was based on clinical outcomes and observations following implant insertion. This includes criteria such as:
- Stable prosthesis without pain, infections, or any pathology
- Absence of radiopaque images around the implant
- No implant loss or fracture
- Bone loss not exceeding 2-3mm
- No infection
8. The Sample Size for the Training Set
There is no mention of a training set as this study is a clinical evaluation of a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned.
§ 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.