(89 days)
Mosaic is used for direct and indirect restorations (inlays, onlays, and veneers) in both the anterior and posterior regions.
Mosaic is a light-cured, bisGMA-based universal restorative composite. Mosaic is radiopaque and available in multiple shades. It has a nano-hybrid composite containing zirconia-silica glass ceramic and 20 nanometer silica. Filler load is 68% by volume for the dentin shades and 56% for the enamel shades. Mosaic is supplied in multi-use syringes (4.0 grams) and single compules (0.2 grams).
This document describes the premarket notification for the Mosaic™ Universal Composite, a dental resin material. It is a PMA document that focuses on demonstrating substantial equivalence to predicate devices based on chemical, mechanical, and physical properties, as well as intended use and safety. The provided text is a regulatory submission for a dental device, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study design for AI/ML devices, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI/ML algorithm is not applicable to this document. The document pertains to a physical dental material.
Here's an analysis of the provided text in the context of device acceptance, even though it's not an AI/ML device:
Device: Mosaic™ Universal Composite (Tooth Shade Resin Material)
Applicant: Ultradent Products, Inc.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct "acceptance criteria" table in the sense of predefined thresholds for specific performance metrics that the device must meet to be approved. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. This is a common regulatory pathway for Class II medical devices. The performance is reported in terms of characteristics that are compared to the predicates.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Mosaic™ Universal Composite) |
|---|---|---|
| Intended Use | Functionally equivalent to predicate devices for direct and indirect restorations | Used for direct and indirect restorations (inlays, onlays, and veneers) in both anterior and posterior regions. |
| Intended User | Licensed dentist (same as predicates) | Licensed dentist |
| Chemical Characteristics | Bis-GMA based resin (similar to predicates) | Bis-GMA based resin, nano-hybrid composite containing zirconia-silica glass ceramic and 20 nanometer silica. |
| Delivery System | Similar to predicate systems (compule, syringe) | Compule, syringe |
| Physical Properties | Similar shelf life, radiopacity, light cure system, and filler load to predicates. | 24-month shelf life (room temperature), available in VITA shades, radiopaque, light cure system. Dentin shade: 68% Filled by Volume; Enamel shade: 56% Filled by Volume. |
| Biocompatibility | Meets ISO 10993 standards (similar to predicates) | Cytotoxicity, Genotoxicity, Delayed-Type Hypersensitivity, Irritation assessed (in accordance with EN ISO 10993-1:2009). |
| Functional Testing | Meets ISO 4049 standards for polymer-based restorative materials (similar to predicates) | ISO 4049:2009 |
| Risk Analysis | Identified, assessed, and controlled to levels as low as currently feasible, no hazardous residual risks. | Performed utilizing processes based on ISO 14971:2012. Residual risks not considered hazardous. |
2. Sample Size Used for the Test Set and Data Provenance:
This document describes a regulatory submission for a physical dental material, not an AI/ML algorithm evaluated on a "test set" of data. Therefore, the concept of a "sample size for the test set" is not applicable in the context of an AI/ML evaluation. The product's performance is based on laboratory testing of the material itself and comparison to established predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This is not applicable as the document is about a material, not an AI/ML system requiring expert-established ground truth from a dataset.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Not applicable. This is not an AI/ML device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. There is no AI/ML algorithm involved.
7. The Type of Ground Truth Used:
For this dental material, the "ground truth" for its performance and safety is established through:
- International Standards: Adherence to standards like ISO 4049:2009 (Dentistry - Polymer-based restorative materials) and EN ISO 10993-1:2009 (Biocompatibility testing).
- Laboratory Testing: Physical and chemical properties are measured in a laboratory setting.
- Comparison to Predicate Devices: The key "ground truth" for regulatory acceptance here is that the new device is "substantially equivalent" to legally marketed, previously cleared devices, meaning it performs similarly and presents similar safety and effectiveness profiles.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.