(77 days)
ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations and is indicated for all carious classes.
For use as a tooth shade resin in dental procedures.
ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations.
The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA.
This document describes the 510(k) summary for ESTELITE SIGMA QUICK, a tooth shade resin material. The device is intended for use in anterior and posterior restorations and for all carious classes.
Based on the provided text, a conventional acceptance criteria table and detailed study information as typically seen for AI/ML device submissions cannot be generated. This is because the submission is for a dental material, not an AI/ML powered device. The "study" referenced in the document is a substantial equivalence determination rather than a clinical trial with performance metrics.
Here's a breakdown based on the provided text, explaining why certain sections cannot be fulfilled:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Substantial Equivalence | Demonstrates substantial equivalence to legally marketed predicate devices. | The chemical structure is "nearly identical" to ESTELITE SIGMA (K#980051) and ESTELITE FLOW QUICK (K#051808). Differences "do not raise new questions of safety or effectiveness." |
| Intended Use | For use in anterior and posterior restorations and all carious classes. | Matches the stated Intended Use. |
| Curing Time | Shorten the curing time compared to ESTELITE SIGMA. | ESTELITE SIGMA QUICK is "formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA." (Note: No specific quantitative performance metric is provided for the reduction in curing time). |
| Radiopacity | Radiopaque | Radiopaque (stated in "Intended Use" description) |
Rationale: The provided text is a 510(k) summary for a dental material (resin), not an AI/ML device. Therefore, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices and meeting general material properties. There are no performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI/ML diagnostic or therapeutic device. The "reported device performance" is descriptive of its characteristics relative to its predicates and intended function.
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 applicable and not provided in the document because this 510(k) pertains to a medical device material (tooth shade resin) and not an AI/ML-powered diagnostic or therapeutic device that would typically undergo testing with a 'test set' of data. The assessment here is based on chemical composition and material properties compared to predicate devices, not on the analysis of patient data.
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 information is not applicable and not provided in the document. As explained above, this is for a dental material, not an AI/ML device requiring expert-established ground truth on a test set of data. The FDA's assessment is based on the provided chemical and physical properties and comparison to predicate devices, not on expert interpretations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. There is no 'test set' in the context of an AI/ML device validation that would require an adjudication method.
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 information is not applicable and not provided in the document. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a dental material like ESTELITE SIGMA QUICK.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. "Standalone algorithm performance" refers to the performance of an AI/ML algorithm on its own, which is not relevant for a dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the document. The concept of "ground truth" as used in AI/ML device evaluations (e.g., pathology, clinical outcomes, expert consensus on images) is not relevant for the substantial equivalence determination of a dental material. The "truth" in this context is based on the known properties and safety of the predicate devices and the chemical and physical characterization of the new device.
8. The sample size for the training set
This information is not applicable and not provided in the document. There is no 'training set' for a dental material. This concept is relevant for AI/ML models that learn from data.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document. As there is no training set, there is no ground truth establishment for it.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the 510(k) premarket notification process for demonstrating substantial equivalence. The manufacturer, Tokuyama Dental Corporation, presented information to the FDA to show that the ESTELITE SIGMA QUICK is substantially equivalent to their own legally marketed predicate devices: ESTELITE SIGMA (K#980051 as modified) and ESTELITE FLOW QUICK (K#051808).
Key elements of this "study" as described in the document:
- Comparison of Chemical Structure: The document states, "The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA... and ESTELITE FLOW QUICK..."
- Discussion of Differences: While the ESTELITE SIGMA QUICK has a "slightly different chemical formulation," the manufacturer asserted that "these differences do not raise new questions of safety or effectiveness." One key difference highlighted is that ESTELITE SIGMA QUICK is "formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA."
- Intended Use Alignment: The intended use for ESTELITE SIGMA QUICK (anterior and posterior restorations, all carious classes, radiopaque, light-cured) aligns with the typical uses of such dental materials and presumably with its predicates.
- FDA Review: The FDA reviewed the submitted information and determined that the device is "substantially equivalent" to the legally marketed predicate devices, thereby allowing it to proceed to market. The FDA's issuance of the substantial equivalence determination serves as the "proof" that the device meets the regulatory acceptance criteria for market authorization.
It's crucial to understand that this is a material science and regulatory compliance "study," not a clinical performance study as would be conducted for an AI/ML diagnostic device.
§ 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.