FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The composite is radiopaque, with total inorganic load of 72% to 80% in weight (52% to 60% in volume), average particles between 0.8 and 0.9 microns. It does not contain Bis-GMA nor Bis-EMA in its formula, following the present trend of products not made with Bisphenol A (BPA).
The composite has APS as its photoinitiation system. APS stands for Advanced Polymerization System, and consists of a combination of different photoinitiators that interact among themselves amplifying the curing capacity of the light emitted by the light-curing device.

AI/ML Overview

The provided text describes the regulatory filing for the Dentscare Vittra APS Unique dental composite, focusing on its substantial equivalence to a predicate device (Llis, Vittra APS). The document outlines performance criteria for both devices through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (from ISO 4049 unless specified)	Vittra APS Unique Performance	Llis Performance	Vittra APS Performance
Sensitivity to ambient lighting	Physical homogeneity: No difference in physical homogeneity when compared to a non-exposed sample after visual inspection by three normal-vision observers.	All samples physically homogeneous, meets ISO 4049.	All samples physically homogeneous, meets ISO 4049.	All samples physically homogeneous, meets ISO 4049.
Depth of Cure	> 1.5 mm	4.91 mm	2.44 mm	2.43 mm
Colour tone stability after radiation and water absorption	No more than a small change in color as visually inspected by three normal-vision observers. Comparison made at 200-300 mm distance for max 2 seconds, in a D65 light chamber, on a white background (90% reflectance) surrounded by a grey background (30 ± 5% reflectance).	Observers did not attest any difference of color. Meets ISO 4049.	Observers did not attest any difference of color. Meets ISO 4049.	Observers did not attest any difference of color. Meets ISO 4049.
Radiopacity	> 1.0 mm (when compared to aluminum scale)	2.23 mm	1.98 mm	2.31 mm
Flexural Strength	≥ 80 MPa	137.8 MPa	138.8 MPa	142.6 MPa
Water Sorption	Maximum of 40 µg/mm³	7.93 µg/mm³	16.32 µg/mm³	15.55 µg/mm³
Water Solubility	Maximum of 7.5 µg/mm³	1.59 µg/mm³	4.78 µg/mm³	4.06 µg/mm³
Accelerated Stability Studies	Confirm 3-year shelf-life at 30°C.	3-year shelf-life confirmed.	(Not explicitly stated for predicate in table, but implied by substantial equivalence)	(Not explicitly stated for predicate in table, but implied by substantial equivalence)
Long-term Stability Study	Verify physical and chemical characteristics during expected shelf life.	Test not yet completed in full. Commercialized based on accelerated stability.	(Not applicable for predicate comparison in this context)	(Not applicable for predicate comparison in this context)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., number of specimens for depth of cure, flexural strength). It mentions:

For Sensitivity to ambient lighting and Color tone stability, "samples in triplicate" were read, and "All comparisons were carried out by observers with normal eyesight."
For Radiopacity, "The average results obtained..." implies multiple measurements.
For Accelerated Stability Studies, the test period was "274 days."

Data Provenance: The tests were "pre-clinical tests" performed by Dentscare Ltda, a Brazilian company. The data is retrospective for the purpose of this 510(k) submission, as it reports completed test results. The country of origin of the data is Brazil, where Dentscare Ltda is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For Sensitivity to ambient lighting and Colour tone stability, "three observers with normal vision" were used for visual inspection. No further specific qualifications (e.g., "radiologist with 10 years of experience") are provided beyond "normal vision."

4. Adjudication Method for the Test Set

For visual comparisons (Sensitivity to ambient lighting, Colour tone stability), the method appears to be a consensus or majority opinion among the three observers, as it states, "The observers did not attest any difference of color." There is no explicit "2+1" or "3+1" adjudication mentioned, but simply that the observers collectively confirmed no difference.
For quantitative tests (Depth of Cure, Radiopacity, Flexural Strength, Water Sorption/Solubility), the ground truth is established by objective laboratory measurements against the ISO 4049 standard, not expert adjudication in the same sense as image interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a dental composite material, not an AI or imaging diagnostic device that would typically involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on International Standards specifications, primarily ISO 4049. These standards define measurable physical and chemical properties (e.g., depth of cure, flexural strength, radiopacity) and objective criteria for visual assessments (e.g., requirements for observers' vision, test conditions for color stability).

8. The Sample Size for the Training Set

This information is not applicable as this is a physical dental composite material, not an AI model that requires a training set. The "training" for the device would be its development process and formulation, not a data-based training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above. The "ground truth" during the development (analogous to "training") of such a material would be its chemical composition, manufacturing process, and adherence to design specifications to meet the desired physical properties.

Summary

Regulation Number and Section

§ 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.