(115 days)
Rainbow 360 is a universal bonding agent intended to bond methacrylate-based restorative materials, cements and sealants to dentin, enamel, and various indirect restorative substrates. It can be used in a self-etch mode, selective etch mode or in a total-etch mode for both direct and indirect dental restorative procedures.
Direct Applications
- Light-cured, self-cured and dual-cured composite and compomer restorations.
- Composite/ceramic/metal repairs.
- Tooth preparation and root surface sealer.
- Cavity sealing for amalgam restorations.
- Light-cured or dual-cured core build-ups.
- Bonding of methacrylate-based fissure sealants.
Indirect Applications
- Cementation of veneers
- Cementation of porcelain, composite, and metal-based restorations
- Cementation of endodontic posts
- Cavity sealing as a pretreatment for indirect restorations.
- Prime metal, ceramic, and composite substrates/restorations.
The subject device, Rainbow 360, is a single-component universal dental adhesive intended for direct and indirect dental restorations. Rainbow 360 is formulated to provide reliable bond strengths with any etch technique, on all common substrates and in combination with any resin cements without auxiliary products (silane or metal primers) even in absence of light. Rainbow 360 is available in bottles for multiple uses and Unidose™ for single use. Rainbow 360 is intended for general population use by a dental professional.
The provided text describes the 510(k) summary for the "Rainbow 360" dental bonding agent. This document focuses on demonstrating substantial equivalence to a predicate device (ADH19 / 3M™ Scotchbond™ Universal Plus (K192961)) rather than proving the device meets specific acceptance criteria through a clinical study with human-in-the-loop performance, as might be done for an AI/ML-based diagnostic device.
Therefore, many of the requested criteria (e.g., expertise of ground truth adjudicators, MRMC study, training set details) are not applicable to this type of device submission, which relies on non-clinical performance and biocompatibility testing for substantial equivalence.
However, I can extract the relevant information regarding acceptance criteria and the non-clinical studies performed.
Here's a breakdown based on the provided text:
Key Takeaway: This 510(k) submission for a dental bonding agent relies on non-clinical performance data and biocompatibility testing to demonstrate substantial equivalence to a predicate device. It does not involve a study for an AI/ML-based device with acceptance criteria related to human-in-the-loop performance, ground truth establishment by experts, or MRMC studies.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All test results met their acceptance criteria and support that the Rainbow 360 is appropriately designed for their intended use." However, it does not explicitly list the quantitative acceptance criteria for each test nor the specific reported performance values. It only states that the tests met the criteria.
| Acceptance Criteria (Stated as "met") | Reported Device Performance (Specificity not provided) |
|---|---|
| Bond Strength (per ISO 29022:2013) | Met acceptance criteria. Implies that the bond strength of Rainbow 360 is comparable to or greater than the predicate device and relevant standards. |
| Shipping Performance (per ASTM D4169:2016) | Met acceptance criteria. Ensures the device packaging and product integrity are maintained during shipping. |
| Biocompatibility (per ISO-10993-1:2018, ISO 7405:2018, and sub-parts) | Met acceptance criteria. Confirmed safety relative to cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, and local effects after implantation. |
| Shelf-life Testing (Internal) | Met acceptance criteria. Confirms the stability and effectiveness of the product over its stated shelf life of 2 years. |
| General non-inferiority/similarity to predicate device | The document concludes that "Rainbow 360 is deemed to be substantially equivalent to the Predicate Device as it satisfies all criteria of substantial equivalence and does not raise new concerns." This implies performance is within acceptable limits compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of bond strength samples, number of biocompatibility specimens). It generally states that "Kerr conducted design verification performance testing".
- Data Provenance: Not explicitly stated regarding country of origin for test data, but it's a manufacturer's internal testing. The tests are purely non-clinical and conducted by the manufacturer, not clinical data from patients. The data would be prospective in the sense that the tests were specifically conducted for this submission.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Not Applicable. This is a dental bonding agent validated through physical and chemical performance tests, not through expert-reviewed clinical imaging or diagnostic data requiring human ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "ground truth" established by experts or adjudication needed for the non-clinical tests described. The tests are objective measurements (e.g., bond strength in megapascals, chemical composition analysis, biological interaction assessments).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for AI/ML diagnostic tools where human readers interpret medical images. This device is a dental material, and its performance is assessed via non-clinical laboratory testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML algorithm. Its "performance" is its physical and chemical properties and biological safety.
7. The type of ground truth used
- For Bond Strength: The "ground truth" is the empirically measured force required to break the bond, compared against industry standards (ISO 29022).
- For Biocompatibility: The "ground truth" is the established biological safety criteria in recognized standards (ISO 10993 series, ISO 7405), and the results are evaluated against these criteria.
- For Shipping Performance: The "ground truth" is the ability to withstand simulated shipping conditions as defined by the standard (ASTM D4169).
- For Shelf-life: The "ground truth" is the maintenance of performance characteristics over time.
8. The sample size for the training set
- Not Applicable. This is a physical product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML model is involved.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.