(90 days)
• Direct anterior and posterior restorations
• Core build ups
• Splinting
• Indirect restorations including inlays, onlays, and veneers
Quantium is a light-cured, radiopaque, universal composite. Quantium is designed to blend with the tooth structure when used alone or in the layering technique.
The provided FDA 510(k) summary for the Quantium device (K242816) does not contain information typically associated with AI/ML device evaluations, such as specific acceptance criteria related to accuracy, sensitivity, specificity, or studies involving human readers or ground truth established by experts.
Instead, this document focuses on the nonclinical testing of a dental composite resin material against a predicate device and relevant ISO standards. Therefore, many of the standard questions regarding AI/ML device studies are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that nonclinical testing of Quantium and the predicate device was selected from the "FDA Guidance Document, Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, issued October 2005." The tests were conducted according to ISO 4049:2019.
Acceptance Criteria (Implied by adherence to ISO 4049:2019 and comparison to predicate):
The acceptance criteria are implicitly that Quantium must meet or exceed the requirements set forth in ISO 4049:2019 for the tested properties and perform equal to or better than the predicate device (TrusFIL Universal Composite Restorative, K202063).
Reported Device Performance:
"The nonclinical tests performed on Quantium and the predicate device showed Quantium performed equal to or better than the predicate. In addition, both devices meet the requirements set forth in ISO 4049:2019."
| Test Parameter | Acceptance Criteria | Quantium Performance |
|---|---|---|
| Sensitivity to light | Meets ISO 4049:2019 and ≥ Predicate | Meets ISO 4049:2019 and ≥ Predicate |
| Depth of cure | Meets ISO 4049:2019 and ≥ Predicate | Meets ISO 4049:2019 and ≥ Predicate |
| Flexural strength | Meets ISO 4049:2019 and ≥ Predicate | Meets ISO 4049:2019 and ≥ Predicate |
| Water solubility | Meets ISO 4049:2019 and ≥ Predicate | Meets ISO 4049:2019 and ≥ Predicate |
| Shade/color stability | Meets ISO 4049:2019 and ≥ Predicate | Meets ISO 4049:2019 and ≥ Predicate |
| Radiopacity | Meets ISO 4049:2019 and ≥ Predicate | Meets ISO 4049:2019 and ≥ Predicate |
| Compressive strength | Comparable to Predicate | Performed equal to or better than predicate |
| Flexural modulus | Comparable to Predicate | Performed equal to or better than predicate |
| Hardness after cure | Comparable to Predicate | Performed equal to or better than predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes nonclinical testing of material properties, not a clinical study involving patients or human data. Therefore, the concept of a "test set" and "data provenance" in the context of patient data is not applicable here. The sample sizes for each specific material test (e.g., number of specimens for flexural strength) are not detailed in this summary document. These details would typically be found in the full test reports, which are not provided.
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)
Not applicable. This is a nonclinical material science study, not an AI/ML clinical study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a nonclinical material science study.
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
No. This is a nonclinical material science study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a nonclinical material science study, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by physical and chemical measurements conforming to ISO 4049:2019 standards and direct comparison to a legally marketed predicate device. This is a material science "ground truth," not a clinical ground truth.
8. The sample size for the training set
Not applicable. This is a nonclinical material science device, 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.