(52 days)
This device is used for the following indications. Each indication is same to that of similar products.
- Jacket crown
- Facing crown
- Inlay and onlay
ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers › intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.
ESTENIA consists of Body Resin, Opaque Resin, Opaque Primer, Modeling Liquid, Add-on Primer, Air-Barrier Paste and accessories.
The provided text describes the ESTENIA dental material and its performance characteristics but does not include a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. This document is a 510(k) premarket notification for a dental material, not an AI/ML device. Therefore, many of the questions regarding AI/ML study design (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.
However, I can extract the acceptance criteria (in terms of physical properties and biocompatibility) and the reported performance from the document.
Acceptance Criteria and Reported Device Performance (Physical Properties)
The document refers to ISO 10477:1992 as a relevant standard, but states ESTENIA "is not applicable to ESTENIA because of following reasons" (special activation system, intended use in stress-bearing areas). Despite this, it evaluates properties with "modified test methods" to fulfill "the requirements of ISO 10477 excluding the test methods." Therefore, the requirements of ISO 10477 for these physical properties can be considered the acceptance criteria, and the reported values are the device performance.
| Acceptance Criteria (from ISO 10477 requirements) | Reported Device Performance (ESTENIA) |
|---|---|
| Flexural Strength (MPa) | Body Resin: Transparent: 135, Enamel: 157, Dentin: 175, Cervical: 107 |
| Flexural Modulus (MPa) | Body Resin: Transparent: $1.7 x10^4$, Enamel: $2.3 x10^4$, Dentin: $1.9 x10^4$, Cervical: $2.3 x10^4$ |
| Minimum Strength (presumably related to flexural strength) | Body Resin: Transparent: 83, Enamel: 98, Dentin: 88, Cervical: 71 |
| Water Absorption ($\mu g/mm^3$) | Body Resin: Transparent: 11, Enamel: 7, Dentin: 7, Cervical: 8 |
| Solubility ($\mu g/mm^3$) | Body Resin: Transparent: -2, Enamel: -3, Dentin: -3, Cervical: -2 |
| Colour Stability | No change for Transparent, Enamel, Dentin, Cervical |
Acceptance Criteria and Reported Device Performance (Biocompatibility)
The biocompatibility tests evaluate the safety of the individual components and the cured resin. The acceptance criterion for these tests is generally a "Negative" result, indicating no adverse biological effects.
| Acceptance Criteria (typically "Negative" or meeting LD50 thresholds) | Reported Device Performance (ESTENIA) |
|---|---|
| AL-C Acute Toxicity (LD50) | LD50; not less than 3,000 mg/kg |
| AL-C Genotoxicity (Ames test) | Negative |
| MUS Acute Toxicity (LD50) | LD50; not less than 8,000 mg/kg |
| MUS Genotoxicity (Ames test) | Negative |
| MPA Acute Toxicity (LD50) | LD50; not less than 4,000 mg/kg |
| MPA Genotoxicity (Ames test) | Negative |
| HD Acute Toxicity (LD50) | LD50; not less than 3,000 mg/kg |
| HD Genotoxicity (Ames test) | Negative |
| DMAEM Acute Toxicity (LD50) | LD50; not less than 2,055 mg/kg |
| DMAEM Genotoxicity (Ames test) | Negative |
| Oral Mucos Membrane Irritation Test (cured resin) | Negative |
| Sensitization Test (Maximization test of cured resin) | Negative |
| Acute Toxicity of Leachables (cured resin) | No group indicating weight change, no mouse died |
Non-Applicable or Not Provided Information (for AI/ML context):
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study using a test set of data. The physical property tests involve prepared specimens, and biocompatibility tests use animal models or bacterial cultures.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties comes from direct measurement, and for biocompatibility from established biological endpoints.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML diagnostic or assistive device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical properties, the "ground truth" is the measured value against a standard specification (ISO 10477). For biocompatibility, it's the observed biological response against accepted safety thresholds (e.g., LD50, negative Ames test, no irritation/sensitization).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Additional Study Information (Mechanical Strength Comparison):
The document also provides a comparative study of mechanical strength with predicate devices:
- Study Design: House test methods for compressive strength and flexural strength.
- Performance Comparison:
- Compressive strength (MPa): ESTENIA (620) vs. CONQUEST (473) vs. ARTGLASS (340)
- Flexural strength1 (MPa): ESTENIA (202) vs. CONQUEST (160) vs. ARTGLASS (121)
- Conclusion: The mechanical strengths of ESTENIA are stated to be "substantially equivalent to that of products sold in the U.S. market," and in the presented data, ESTENIA shows higher compressive and flexural strength than the compared predicate devices.
§ 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.