(64 days)
ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.
Intended Use of ILLUSION: dental resin cement
ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.
The provided text describes a 510(k) summary for a dental resin cement called ILLUSION. It aims to establish substantial equivalence to a predicate device, "Choice™," and lacks detailed information typically found in a study report, particularly regarding acceptance criteria and performance data for a medical device that would involve human subjects or complex algorithms.
However, based on the provided information, I can extrapolate the "acceptance criteria" and "device performance" relating to the physical and mechanical properties of the dental cement as these are explicitly compared to the predicate device.
Here's the breakdown of the information as requested, using the available data:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (dental resin cement), the "acceptance criteria" are implied by the performance of the legally marketed predicate device, Choice™. The new device, ILLUSION, is deemed "substantially equivalent" if its performance falls within a comparable range to the predicate device, demonstrating similar safety and effectiveness for its intended use.
| Technological Characteristic | Acceptance Criteria (Predicate Device: Choice™) | Reported Device Performance (ILLUSION™) |
|---|---|---|
| Intended Use | Cement | Cement |
| Chemical Composition | Dual-cured | Dual-cured |
| Physical/Mechanical Properties: | ||
| Diametrical Tensile Strength (Light-cured) | 49 MPa | 43 MPa |
| Diametrical Tensile Strength (Chemical-cured) | 38 MPa | 41 MPa |
| Compressive Strength (Light-cured) | 198 MPa | 260 MPa |
| Compressive Strength (Chemical-cured) | N/A (not reported for predicate) | 231 MPa |
| Barcol Hardness (L/C 20 sec., 2 mm thickness) | 79/60 | 82/59 |
| Modulus (Light-cured) | 8.7 GPa | 5.6 GPa |
| Working Time (Min:Sec) | 5:00/10:00 | 4:30/9:30 |
Study Proving Device Meets Acceptance Criteria:
The provided document is a 510(k) Summary, which typically references internal testing reports rather than providing them in full detail. The "study" mentioned here refers to the testing conducted by Bisco, Inc. to compare ILLUSION's properties against its predicate. The FDA reviewed these undisclosed test results and determined substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The table indicates numerical values followed by a number in parentheses (e.g., "49 MPa (8)"). This "(8)" or "(6)" likely represents the number of samples or measurements taken for that specific physical property test (e.g., 8 samples for diametrical tensile strength, 6 for compressive strength). This is a very small sample size for a "test set" in the context of clinical studies, but common for material property testing.
- Data Provenance: The data is generated by Bisco, Inc., a company located in Schaumburg, IL, USA. This would be considered experimental/laboratory data rather than clinical data, and it is prospective in the sense that the testing was performed specifically to characterize the new device. There is no information regarding the country of origin of the data beyond the company's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of submission. For dental cements, "ground truth" is typically established through standardized material property testing, according to recognized ASTM or ISO standards, rather than expert interpretation or clinical consensus. There are no "experts" in the sense of clinicians establishing ground truth for physical properties like tensile strength or hardness, but rather skilled technicians performing tests according to methods.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader interpretations (e.g., radiology images) to resolve discrepancies among experts. For physical property testing, results are quantitative and typically averaged or analyzed statistically; there's no "adjudication" in this sense.
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. MRMC studies are typically used for diagnostic devices involving human interpretation of clinical data (e.g., radiologists reading images). This 510(k) is for a dental material (cement), and its assessment relies on material properties rather than diagnostic performance or human reader interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a "standalone algorithm performance" study was not done. This concept applies to AI/software as a medical device. ILLUSION is a physical dental material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the physical and mechanical properties of the dental cement is established by standardized testing methods (e.g., ISO, ASTM standards for dental materials) that yield quantitative measurements. The predicate device's performance provides the benchmark against which the new device's properties are compared. There is no pathology, outcomes data, or expert consensus used for these specific material properties.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device like a dental cement, there is no "training set" in this context. The characteristics of the material are inherent to its composition and manufacturing process, optimized through formulation development and testing.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no "training set" for this type of 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.