(79 days)
Crown, Bridges, Veneer, Onlay & Inlay, Denture, partial denture, Orthodontic appliance, Splints.
- Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
- For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.
ID LIGHT CURE SYSTEM is a light-curing resin-based coating material for dental use. It is designed to form a film on the resin surface of dental restorations and prosthetic appliances to enhance smoothness and wear resistance. The material is available in 51 shades.
This document is a 510(k) clearance letter for a dental device, the "ID LIGHT CURE SYSTEM." It's important to note that a 510(k) submission primarily demonstrates substantial equivalence to a previously cleared device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Pre-Market Approval).
Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical and biological safety tests performed to demonstrate that the new device performs similarly to the predicate device and does not pose new safety concerns. There is no information in this document about acceptance criteria and performance data for an AI-based or software-driven diagnostic or prognostic device. The product is a physical dental material, a "light-curing resin-based coating material."
Given the nature of the device (a coating material for resin fillings), concepts like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone AI performance," "number of experts for ground truth," or "effect size of human readers with AI assistance" are not applicable. This device is a material, not an AI or imaging diagnostic tool.
However, I will extract the information that is available and clarify what is not applicable based on the provided text for a physical dental material.
Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)
Since this is a physical dental material and not an AI/software device, the "acceptance criteria" are related to its physical and biological properties. The document states that the device "successfully passed all evaluations, demonstrating acceptable physical characteristics and confirming that the product meets its intended technical and performance specifications." This implicitly means the product met its internal acceptance criteria.
Table of Acceptance Criteria and Reported Device Performance
| Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Biological Safety | No added substances specifically inducing toxicity compared to the predicate. | |
| No significantly different elements or mixing ratios compared to the predicate. | ||
| Absence of cytotoxic reactions. | ||
| Absence of oral mucosal irritation or skin sensitization reactions. | ||
| Absence of systemic toxic reactions. | "no observed cytotoxic reactions, no oral mucosal irritation or skin sensitization reactions, and no systemic toxic reactions." | |
| "sufficient data on toxicity and benefits can be observed through the review of literature with long-term use experience" (for some models). | ||
| Considered to not contain added substances specifically inducing toxicity or significantly different elements/mixing ratios compared to predicate. | ||
| Physical Properties | Acceptable appearance. | |
| Acceptable weight. | ||
| Packaging integrity. | ||
| Color stability. | ||
| Sensitivity to ambient light within acceptable limits. | ||
| Adequate depth of cure. | "All tests were performed in accordance with internal protocols and relevant standards. The device successfully passed all evaluations, demonstrating acceptable physical characteristics and confirming that the product meets its intended technical and performance specifications." | |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (OPTIGLAZE COLOR, K133836) in terms of: |
- Indications for Use
- Design
- Material and chemical composition
- Principle of Operation
- Energy source | Indications for Use are stated to be the "same."
Technical characteristics (Design, Material, Principle of Operation, Energy source) are stated to be the "same."
Device is "substantially equivalent to the predicate device." |
Study Details (Applicable points only, based on provided text)
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. For biological safety, tests were performed according to ISO 10993-1:2018 and ISO 7405:2018, which dictate sample sizes for specific in-vitro and in-vivo tests but these are not enumerated here. For physical properties, "a series of performance tests were conducted," but a specific sample size for each test is not provided.
- Data Provenance: Not specified. Standardized biological safety tests (ISO standards) are generally conducted in a controlled lab environment. Physical property tests are conducted internally. It is not specified if any data was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical dental material; "ground truth" and "expert adudication" as typically understood for AI diagnostic devices (e.g., radiologists interpreting images) do not apply. Biological safety and physical property tests have objective measurements and pass/fail criteria based on standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
-
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:
- Not Applicable. This is a physical dental material, not an AI or imaging diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to AI algorithm performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biological Safety: Ground truth is established by adherence to international standards (ISO 10993-1:2018 and ISO 7405:2018) and objective biological endpoints (cytotoxicity, irritation, systemic toxicity).
- For Physical Properties: Ground truth is established by "internal protocols and relevant standards" with objective measurements (appearance, weight, packaging, color stability, sensitivity, depth of cure).
- No expert consensus, pathology, or outcomes data in the sense of clinical decision-making is relevant here.
-
The sample size for the training set:
- Not Applicable. This is a physical dental material, "training set" refers to machine learning.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.