(18 days)
LuxaGlaze is intended for glazing the surfaces of provisional crowns, bridges and custom trays.
The LuxaGlaze material is a visible light-cured dental, one-component dental varnish material.
The provided document does not describe any acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, the document is a 510(k) premarket notification summary for a dental device called "LuxaGlaze." The primary method for proving the device's safety and effectiveness is through a demonstration of substantial equivalence to existing predicate devices.
Here's a breakdown of why this information is absent and what the document does state:
- No Acceptance Criteria or Performance Study: The document explicitly states: "No safety or performance testing was required to establish substantial equivalence for LuxaGlaze." This means the manufacturer did not conduct a study to prove the device met specific performance metrics or acceptance criteria.
- Substantial Equivalence: The basis for clearance is that "Substantial equivalence for this device was based on similarities in materials, design and performance characteristics" to a legally marketed predicate device (belleGlaze material, K992067). This is a regulatory pathway where a new device is shown to be as safe and effective as an already-cleared device, often without requiring new clinical or performance studies if the technological characteristics are sufficiently similar.
Therefore, I cannot provide the requested table or information about a study, sample sizes, experts, adjudication methods, or MRMC studies because they were not performed or reported in this 510(k) submission.
The document states:
| Information Requested | Status as per document |
|---|---|
| 1. Table of acceptance criteria and reported performance | Not applicable. No acceptance criteria or specific device performance metrics are reported. The device's safety and performance were established through substantial equivalence to a predicate device based on similarities in materials, design, and general performance characteristics. |
| 2. Sample size and data provenance for test set | Not applicable. No performance or clinical test set was used or described. The clearance was based on substantial equivalence to a predicate device. |
| 3. Number and qualifications of experts for ground truth | Not applicable. No ground truth was established by experts for a test set, as no performance or clinical testing was conducted. |
| 4. Adjudication method for test set | Not applicable. No test set or adjudication method was used. |
| 5. MRMC comparative effectiveness study and effect size | Not applicable. No MRMC study was performed or reported. The regulatory pathway relied on substantial equivalence. |
| 6. Standalone performance study | Not applicable. No standalone algorithm performance (human-in-the-loop performance) was done as this is a dental varnish, not an AI/software device. Furthermore, no performance testing (standalone or otherwise) was required or conducted. |
| 7. Type of ground truth used | Not applicable. No ground truth was established or used, as no performance or clinical testing was conducted. The basis was substantial equivalence to a predicate device based on similarities in materials, design, and indicated use. |
| 8. Sample size for training set | Not applicable. There is no mention of a training set as this is a physical dental material, not an algorithm, and no performance data from studies are presented. |
| 9. How ground truth for training set was established | Not applicable. No training set or ground truth for a training set was established. The clearance was based on demonstrating substantial equivalence to a legally marketed predicate device, relying on the inherent safety and performance characteristics of similar, previously cleared devices and materials, rather than new performance data from this specific device. The conclusion states: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the DMG USA LuxaGlaze material has been shown to be safe and effective for its intended use." |
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.