(178 days)
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The Medentika TiBases are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The TiBases are provided in several models and dimensions, according to the compatible implant systems declared in the Indications for Use statement.
The design of the CAD/CAM restorations is to be carried out through the Straumann CARES Visual Plug-In for Dental Wings CAD System. The patient-specific restorations must be milled by a Straumann milling center.
This document is a 510(k) submission for the Medentika CAD/CAM TiBases, which are dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo approval requiring extensive clinical studies with acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes for AI/ML devices. Therefore, much of the requested information regarding AI/ML specific studies (MRMC, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods) is not applicable to this type of device submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this device (dental implant abutments), the "acceptance criteria" are related to mechanical performance and biocompatibility, demonstrating that the new devices are as safe and effective as the predicate devices. The performance data presented are primarily comparative to predicate devices rather than against specific numerical thresholds in a table.
| Acceptance Criteria Category | Device Performance (as described in the document) |
|---|---|
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2009 and FDA Guidance. New issues of biocompatibility not raised as the subject devices have identical body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to primary predicate devices. |
| Sterilization Validation | Medentika titanium bases are non-sterile; user sterilization is recommended. The recommended cycle has been validated to a sterility assurance level (SAL) of 10⁻⁶ by the overkill method, according to ISO 17665-1 and ISO 17665-2. |
| Mechanical Performance | Demonstrated through fatigue testing performed according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) and FDA guidance for Class II Special Controls. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices. |
| Dimensional Analysis | Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws (details on results not explicitly given, but implies successful comparison). |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML device evaluating data. For mechanical testing, specific sample sizes are not provided in this summary, but would typically be defined by the relevant ISO standards (e.g., ISO 14801). The "data provenance" would be from laboratory testing performed on the physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of device submission. Dental implant abutments do not use expert-established ground truth in the same way an AI diagnostic algorithm would.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this is not an AI/ML device, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device (dental implant abutment), not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility and sterilization, the "ground truth" is established by adherence to international standards (ISO 10993-1, ISO 17665-1/2) and successful completion of the tests defined within those standards. For mechanical testing, the "ground truth" is the established performance of the predicate device under specified fatigue test conditions as per ISO 14801.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)