(30 days)
The principle uses of All Bond 3 are:
- All Direct Restorations .
- All Indirect Restorations ●
- Intra-oral Repair .
- Desensitizing/sealing of tooth structure .
All-Bond 3 is an ethanol based dual-cured adhesive system that is compatible with all dental materials.
The provided document is a 510(k) Summary for a dental adhesive, All-Bond 3. It does not present a study with specific acceptance criteria and performance results for an AI/CAD-based device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through chemical and physical property comparisons and biocompatibility testing.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, expert qualifications, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as it describes a traditional medical device, not an AI/CAD system.
However, I can extract the information relevant to its substantial equivalence claim, which serves a similar function to "acceptance criteria" in this context, and the "study" that proves it.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For traditional medical devices seeking 510(k) clearance, the "acceptance criteria" for substantial equivalence often relate to demonstrating similar technological characteristics, intended use, and performance to a legally marketed predicate device. The "reported device performance" is then the comparison showing this similarity or superiority.
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | All-Bond 3 Performance (vs. Predicate) |
|---|---|
| Intended Use | Same as predicate (direct/indirect restorations, intra-oral repair, desensitizing/sealing) |
| Indications for Use | Same as predicate (direct/indirect restorations, intra-oral repair, desensitizing/sealing) |
| Chemical Composition | Similar, methacrylate resin based, contains ethanol solvent. Differs from All-Bond 2 by not containing Acetone Solvent, but matches All-Bond XL in this regard. |
| Physical/Mechanical Properties | Performs "as well as or better than" the predicate devices (e.g., thin solutions for components, low viscosity when mixed, dental substrate priming/wetting agent, bonding agent to tooth structure). |
| Biocompatibility | Safe for its intended use, based on FDA guidelines and ISO 4049:2009. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "QA/QC or R&D test protocols" for physical/mechanical properties and "FDA guidelines and ISO 4049:2009" for biocompatibility, but no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are mentioned for the tests conducted to compare All-Bond 3 to its predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the clearance is for a dental adhesive, not an AI/CAD system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this type of device would be established through laboratory testing and validated industry standards.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD systems that assist human readers in tasks like diagnosis or detection, which is not the function of a dental adhesive.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone performance evaluation is not applicable. This is for AI algorithms, and the device is a chemical dental product. The performance evaluation was based on physical, mechanical, and biocompatibility testing.
7. The Type of Ground Truth Used
The "ground truth" for claiming substantial equivalence primarily relies on:
- Chemical composition analysis: Comparing the ingredients.
- Physical/mechanical property measurements: Standard laboratory tests (e.g., viscosity, bond strength, flow characteristics, though not all explicitly detailed here) according to QA/QC or R&D protocols.
- Biocompatibility testing: Adherence to FDA guidelines and ISO 4049:2009 standards.
8. The Sample Size for the Training Set
This information is not applicable as the device is a chemical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.