(276 days)
The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the InCoris mesostructure. The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implants systems:
The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.
The system that features the processing of mesostructures comprises
- Titanium bases TiBase and Camlog
- inCoris ZI meso blocks
- Sirona Dental CAD/CAM Design and fabricating devices
Titanium bases are used as an implant prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity.
inCoris ZI meso blocks are used in manufacturing individually designed inCoris ZI meso mesostructures, which are glued to a fitting titanium base after milling and sintering.
Sirona Dental CAD/CAM design and fabricating devices feature the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. This component consists of the devices CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL.
The provided document is a 510(k) summary for a dental CAD/CAM system. It does not contain information about studies involving acceptance criteria in the traditional sense of AI/ML performance evaluation (e.g., sensitivity, specificity, accuracy, F1-score). Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, materials, design, and physical/performance characteristics.
Therefore, many of the requested categories for AI/ML study details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to the content presented in this 510(k) summary.
The closest equivalent to "acceptance criteria" and "device performance" in this context are the physical and chemical properties of the materials and the design/functional equivalence to established predicate devices.
Here's an attempt to extract relevant information given the nature of the document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for overall device performance. Instead, it compares the new device's characteristics to those of predicate devices, arguing for "substantial equivalence." The performance characteristics listed are material properties and design features.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Sirona Dental CAD/CAM System Components) |
|---|---|
| TiBase: | |
| Material: Ti6Al4V (medical grade 5) | Made of Ti6Al4V (medical grade 5) |
| Connection interfaces to implants: Identical to predicates for each diameter/type | Identical to predicates; notch in addition for dental restorations |
| Abutment screw material: Ti6Al4V | Made of Ti6Al4V |
| Physical properties: Comply with ISO 5832-3:1996 | Complies with ISO 5832-3:1996 |
| inCoris ZI meso: | |
| Material: Zirconium oxide, similar composition to predicates | Zirconium oxide (ZrO2+HfO2+Y2O3 > 99.0%, Al2O3 6.00 g/cm³ (from predicate) |
| Flexural strength: > 800MPa (from predicate) | > 900MPa |
| Anti-rotational feature: Notch | Notch |
| Bonding Material: Panavia F 2.0 | Panavia F 2.0 |
| CAD/CAM Design & Fabrication Devices: | |
| Ability to take optical impressions | Yes (CEREC3, CEREC AC, inEos, inEos Blue) |
| Design mesostructures from recorded data (CAD) | Yes (Sirona Dental CAD/CAM Software) |
| Fabricate/mill mesostructures (CAM) | Yes (CEREC MCXL, inLab MCXL) |
| Transfer data to remote milling machine | Yes (via internet/exportation/importation) |
| Scan Implant Interface/surface | Yes (or with mounted scanbody) |
| Scan custom wax-up | Yes |
| Preparation of customized mesostructure | Yes |
| Bond milled mesostructure to metal abutment | Yes |
| Create fitting crown | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a medical device submission based on substantial equivalence to existing predicate devices, not a clinical or performance study with a test set of data. The "testing" referred to is nonclinical (fatigue analysis, reverse-engineering for design equivalence).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not relevant in this context. The document relies on engineering analysis and comparison against established standards and predicate device specifications.
4. Adjudication method
Not applicable. Adjudication methods are used in studies involving expert review, which is not described here.
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 CAD/CAM system for fabricating dental restorations, not an AI-assisted diagnostic or interpretive device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The CAD/CAM system involves an optical acquisition unit, software for design (human-in-the-loop), and milling machines. It's not a standalone algorithm in the AI/ML sense.
7. The type of ground truth used
For the material and physical properties, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5832-3:1996 for TiBase material, ISO 13356:1997 for inCoris ZI meso material) and direct comparison to predicate device specifications.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML algorithm requiring learning from data.
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.)