(128 days)
Indications for Use: Post cementation and core build-up
The subject device is a dual-cured (light-cured with self-curing property), radiopaque two-component core build-up material supplied in an automix delivery system which can mix equal amount of two components, and is available in two shades, Dentin and White.
This document describes a 510(k) premarket notification for a dental device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, and MRMC studies, is not applicable or available within this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, chemical ingredients/safety, and physical/mechanical properties.
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance (Summary) |
|---|---|
| ISO 4049: 2009 Requirements | Complies with the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states that physical and mechanical properties were evaluated according to ISO 4049: 2009, but it does not specify the sample size used for these evaluations or the data provenance.
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)
This is not applicable as this is a dental material device, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The evaluation focused on compliance with a technical standard (ISO 4049).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as above. There was no "test set" in the context of expert judgment for ground truth.
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
This is not applicable. This is a dental material device, not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the requirements of the ISO 4049: 2009 standard for physical and mechanical properties of polymer-based restorative materials. The device's performance was compared against these predefined physical and mechanical thresholds.
8. The sample size for the training set
This information is not provided and is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device requiring a training set or its associated ground truth establishment.
§ 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.