(15 days)
Use for most bonding needs in restorative dentistry. Peak™ Bond is formulated to work well with flowable composite for light cure luting. Ultradent recommends the PermaFlow® DC system using chemical cure PermaFlow® DC primer for chemical cure/dual core bonding (e.g., non-translucent veners, inlays, and post bonding). Peak™ Bond bonds to the following materials: Dentin and enamel, Porcelain, Metal, Composite.
Peak™ Bond is a single syringe delivered, single component resin bonding system. It is a light curing bonding agent with an ethyl alcohol solvent carrier. It will cure with most all lights (not laser). Peak™ Bond is 7.5% filled and is radiopaque. Peak™ Bond is a single resin-bonding agent that provides high bond strength and helps prevent micro leakage. It's unsurpassed filler penetration into dentin tubles helps minimize sensitivity. It is radiopaque, has an ethyl alcohol carrier, cures with all lights and is used with light curing indirect bonding. Peak Bond's unique and patented chemistry bonds to dentin/enamel, cast metal, porcelain and composite. It is also effective for indirect procedures where light curing is possible.
The provided text is a Special 510(k) Premarket Summary for a dental bonding agent called Peak™ Bond, and the FDA's response letter. It focuses on demonstrating substantial equivalence to a predicate device (PQ1®) through various comparisons and testing.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds in the typical sense for a medical device. Instead, the acceptance criterion implicitly appears to be "met or exceeded testing expectations" when compared to the legally marketed predicate device (PQ1®). The performance is reported qualitatively as "Peak™ Bond has met or exceeded our testing expectations. It is simply a thinner version of our PO1."
| Acceptance Criteria | Reported Device Performance (Peak™ Bond) |
|---|---|
| Intended Use: Same as predicate | Same as predicate (Use for most bonding needs in restorative dentistry; formulated to work well with flowable composite for light cure luting). |
| Bonding: Same as predicate | Bonds to Dentin and enamel, Porcelain, Metal, Composite (Same as predicate). |
| Description: Single resin bonding agent, 7.5% filled, radiopaque, light curing, ethyl alcohol solvent carrier. | Single resin bonding agent, 7.5% filled, radiopaque, light curing, ethyl alcohol solvent carrier. |
| Biocompatibility and Safety: Passed cytotoxicity testing. | Passed cytotoxicity testing (Same as predicate). |
| Properties: Radiopaque, light curing. | Radiopaque, light curing (Same as predicate). |
| Technological Characteristics: High bond strength, helps prevent micro leakage, minimizes sensitivity due to filler penetration into dentin tubules. | Provides high bond strength, helps prevent micro leakage, unsurpassed filler penetration into dentin tubules helps minimize sensitivity. Bonds to dentin/enamel, cast metal, porcelain, and composite. |
| Other Tests (implicitly compared to predicate): % Filled, Ingredients, Radiopacity, Shrinkage, Bond Strength. | Met or exceeded testing expectations for these categories, implying performance is equivalent or better than the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific details on the sample size for any of the tests conducted (e.g., cytotoxicity, shrinkage, bond strength). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies described are laboratory tests of a dental bond agent's physical and chemical properties, not diagnostic imaging or clinical studies requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no mention of human-in-the-loop assessment or any form of adjudication for the test set. The tests described are laboratory-based material property assessments.
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
Such a study was not done. This document describes a dental bonding agent, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as this is a dental product, not an algorithm or AI device. The testing performed focused on product performance (e.g., bond strength, radiopacity, biocompatibility).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the laboratory tests mentioned (e.g., cytotoxicity, shrinkage, bond strength), the "ground truth" would be established by the physical and chemical measurements obtained from validated scientific methods and instrumentation, compared against established standards or the performance of the predicate device. It's not based on expert consensus, pathology, or outcomes data in the sense of clinical diagnoses.
8. The sample size for the training set
This is not applicable. The device is a dental bonding agent, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As stated above, there is no AI or machine learning model 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.