(46 days)
iBond Self Etch is used for bonding of direct light-cured composite restorations (including Polyglas and copomers), bonding of indirect restorations in combination with a light-curing luting cement; porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns) and sealing hypersensitive areas of teeth.
iBond Self Etch(new formulation is an acetone/water-based formulation of light activated methylacrylate resins.
The provided text refers to a dental bonding agent, iBond Self Etch, and its new formulation. The "study" described is a declaration of substantial equivalence to a predicate device, focusing on material properties and biocompatibility rather than a clinical trial in the traditional sense of comparing AI performance to human performance. As such, many of the requested elements for AI/MRMC studies are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate) | Reported Device Performance (New iBond Self Etch) |
|---|---|
| Shear Bond Strength: >15 MPa | Shear Bond Strength: ≥20 MPa |
| Storage condition: Refrigeration required | Storage condition: No refrigeration required |
| Handling: Shaking necessary | Handling: No shaking necessary |
2. Sample Size Used for the Test Set and Data Provenance
- The document describes a modification to an existing device (iBond Self Etch) and a comparison to its predicate (HK Bond K063062).
- The "test set" in this context refers to the samples of the new formulation used for laboratory testing of properties like shear bond strength.
- Sample Size: Not explicitly stated for each test, but it is implied that standard laboratory testing procedures were followed for material characterization.
- Data Provenance: The studies were conducted internally by Heraeus Kulzer, LLC. The document does not specify country of origin for the data (beyond the applicant being in the US) or if it's retrospective or prospective, but it implies prospective lab testing of the new formulation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is not a study requiring human expert assessment for ground truth. The "ground truth" for material characteristics like shear bond strength is established by standardized laboratory testing protocols, not expert consensus.
4. Adjudication Method for the Test Set
- Not applicable for the reasons stated above.
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 is not an AI device, and therefore no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
- Not applicable. This is not an AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the material properties (e.g., pH, refractive index, shear bond strength), the ground truth is established through objective, standardized laboratory measurements following established protocols relevant to dental materials.
- For biocompatibility, the ground truth is based on adherence to international standards (EN ISO 10993) and a toxicological assessment of leachable compounds.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI device, so there is no "training set." The understanding of the device's formulation and properties comes from chemical development and iterative laboratory testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated above.
Summary of the "Study" (Rationale for Substantial Equivalence):
The submission argues for substantial equivalence by demonstrating that the new iBond Self Etch formulation is comparable to its predicate (HK Bond K063062) despite minor modifications (addition of a stabilizer, change in rheological additive). The key elements of the "study" are:
- Comparison of Technical Characteristics: A detailed table highlights that many parameters (content of BHT, indications for use, visual appearance, pH, refractive index, application, dwell time, curing time, compatibility) remain the same.
- Performance Testing: The crucial difference in shear bond strength was tested, and the new formulation exceeded the predicate's performance requirement (>15 MPa for predicate vs. ≥20 MPa for new formulation).
- Biocompatibility Evaluation: The biological compatibility was verified in accordance with EN ISO 10993. A toxicologist reviewed the leachable compounds, concluding that the safety is equivalent to the predicate. No in vivo toxicity studies were performed on the new formulation due to low exposure and animal welfare, relying on the previous testing of the predicate and the toxicological assessment of leachable compounds.
- Risk Analysis: A risk analysis according to ISO 14791 was conducted, concluding that the safety of the new formulation is substantially equivalent.
- Improved Usability: The new formulation offers improved convenience (no refrigeration required, no shaking necessary) while maintaining or improving performance.
In essence, the study is a series of laboratory tests and regulatory assessments to confirm that the minor formulation changes do not negatively impact the device's safety and effectiveness and, in some cases, improve its performance and user convenience.
§ 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.