(323 days)
Orthocem: Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface.
Ortho bite: The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.
Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product's removal from teeth, after removing brackets.
Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. Its composition includes dimethacrylate monomers, HEMA Phosphate, traditional Camphorquinone/DABE system as photoinitiator and silica as load particle. The combination of silica load fillers with the dimethacrylate monomer composition results in a viscosity that allows it to be handled and applied without running off the application area. The presence of HEMA Phosphate allows adhesion to the enamel surface, which is a known feature of composite cements indicated for bracket bonding. The thixotropy allows the product to have self-levelling capability, known as a shear thinning property that makes the composite settle correctly on the occlusal surface. The product is colored in order to facilitate its identification during application and removal.
The provided document is a 510(k) Premarket Notification from the FDA for two dental adhesive devices, "Orthocem" and "Ortho Bite". It details the equivalence to predicate devices based on non-clinical testing of material properties, not a study involving AI or human readers for diagnostic performance. Therefore, many of the questions related to AI-specific evaluation metrics, human expert involvement, and clinical study design (like MRMC, effect size, training/test sets for AI, and adjudication) are not applicable to this submission.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based only on the information available in the provided text:
Key Takeaway: This 510(k) submission focuses on demonstrating substantial equivalence of dental materials based on physical, chemical, and mechanical properties, not on AI-driven diagnostic performance or human reader studies. The "study" mentioned refers to non-clinical laboratory tests.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally derived from recognized international standards like ISO 4049, ISO 10993, and ISO 29022. The reported device performance is compared against these standards.
| Test / Property | Acceptance Criteria (Specification) | Orthocem Performance (Results) | Ortho Bite Performance (Results) |
|---|---|---|---|
| Sensitivity to Ambient Lighting (ISO 4049) | Physical homogeneity of the sample; no difference compared to unexposed material. | All results within the range specified by ISO 4049. | All results within the range specified by ISO 4049. |
| Depth of Cure (ISO 4049) | > 1.0 mm for opaque materials, > 1.5 mm for non-opaque materials. | All results greater than the specified threshold. | All results greater than the specified threshold. |
| Flexural Strength (EN ISO 4049) | ≥ 50 MPa | 82.01 MPa (Table on page 7), All results greater than the specified threshold (page 10). | 118.30 MPa (Table on page 7), All results greater than the specified threshold (page 11). |
| Water Sorption | Maximum of 40 µg/mm³ | 31.43 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 10). | 30.16 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 11). |
| Water Solubility | Maximum of 7.5 µg/mm³ | 5.66 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 10). | 5.76 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 11). |
| Shear Bond Strength (ISO 29022) | Test verifies adhesive bond strength; no specific numerical acceptance criterion stated, but compared to predicate. | 14.70 MPa (Table on page 8, also reported on page 10 and 11). | 14.76 MPa (Table on page 8, also reported on page 10 and 11). |
| Accelerated Stability Studies | Study to accelerate chemical degradation/physical changes in forced conditions. | Confirms 2-year shelf-life at 30°C. | Confirms 3-year shelf-life at 27°C. |
| Long-Term Stability (Shelf-Life) | Verify physical/chemical characteristics during expected shelf life to confirm expiration date and storage. | Confirms 2-year shelf-life at 30°C. | Confirms 3-year shelf-life at 30°C. |
| Transport Evaluation Report | Testing according to ASTM D4169. | All evaluated samples met the compression criteria required by ASTM D4169 standard. | All evaluated samples met the compression criteria required by ASTM D4169 standard. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the numerical sample sizes for each non-clinical test (e.g., how many specimens were used for flexural strength tests). It refers to the tests performed "according to the table below" for performance studies.
- Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured product samples, not on patient data. The manufacturer, DENTSCARE LTDA, is based in Brazil (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL). The tests generated prospective data (i.e., designed experiments to evaluate product properties).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the "test set" consists of non-clinical material samples, not patient data requiring expert interpretation (e.g., radiology images). The ground truth is established by the physical and chemical properties of the materials themselves, measured by standardized laboratory methods.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiologist reads) in clinical studies. For physical material tests, results are objectively measured.
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
- Not applicable. This submission is for dental adhesive materials, not an AI-assisted diagnostic device. No MRMC study was performed, and human reader performance with or without AI assistance is not relevant to this device's evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a material, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by physical, chemical, and mechanical measurements of the material properties according to recognized international standards (e.g., ISO 4049, ISO 29022, ISO 10993). This is typically performed through controlled laboratory testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in the context of demonstrating substantial equivalence for dental materials based on physical properties. The "training" for the device's formulation would occur during its research and development phase, but not as part of a formal "training set" for regulatory evaluation in the way AI models are trained.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of this device's regulatory evaluation. The development of the dental adhesive formulation (the "training" of the product itself) would rely on material science principles and iterative laboratory testing to achieve desired properties, rather than a "ground truth" derived from patient data or expert consensus.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.