(67 days)
Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites
Monobond Etch & Prime is used to condition silica-based ceramic surfaces for the adhesive bond with luting composites from the Variolink or Multilink product lines, for example, Monobond Etch & Prime etches and silanizes silicate ceramic suffaces in one working step. The new product combines the role of bonding agent with that of etchant. Typically the dental technician would etch the ceramic with 5% hydrofluoric acid but this step is achieved using Monobond Etch & Prime. The etching step was carried out outside the mouth and the new product is also limited to extra-oral applications of the new product are limited to silica ceramics, Oxide ceramics, metal, composite and fibre-reinforced composites are not indicated. This is because only silica glass ceramics required etching with hydrofluoric acid and therefore the benefit of using Monobond Etch & Prime is primarily relevant for this group of materials.
This document is a 510(k) premarket notification for a dental device, specifically a resin tooth bonding agent called Monobond® Etch & Prime (K150164). The document primarily focuses on establishing substantial equivalence to a predicate device, Monobond Plus (K090826), rather than providing detailed acceptance criteria and a comprehensive study report for the proposed device itself.
Based on the provided text, the information requested cannot be fully extracted for the new device, Monobond® Etch & Prime, because the document is a regulatory submission for substantial equivalence, not a detailed clinical study report with specific performance metrics defined as acceptance criteria.
However, I can extract the available information and highlight what is missing.
Here's an attempt to answer your questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Monobond® Etch & Prime) |
|---|---|
| Tensile Bond Strength to Glass Ceramics | Conforms to specification and substantially equivalent to predicate device. |
| Biocompatibility | Assessed through testing according to EN ISO 10993-1:2009 and EN ISO 7405:2008. (Specific results not given) |
Note on Acceptance Criteria: The document states, "As no product specific standard exists for the subject device," indicating that formal, externally defined acceptance criteria for the new device were not applied verbatim. Instead, the performance was compared to its own internal specification and to the predicate device for substantial equivalence. "Conforming to the specification" implies internal acceptance criteria were met, but the specific numerical values are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "tests for Monobond Etch & Prime and Monobond Plus tensile bond strength" but does not provide details on the number of samples or specimens tested.
- Data Provenance: Not specified. The country of origin of the data is not mentioned, nor is it stated whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided as this is not a study involving expert assessment or ground truth establishment in a clinical context. The testing described is laboratory-based physical and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as this is not a study involving human interpretation of data requiring adjudication.
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
This information is not applicable/not provided. The device is a dental bonding agent, not an AI or imaging diagnostic tool that would typically involve MRMC studies or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical product (a chemical agent), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tensile bond strength testing, the "ground truth" would be the physically measured bond strength under controlled laboratory conditions, not expert consensus, pathology, or outcomes data. For biocompatibility, the ground truth would be the results of standardized biological assays per EN ISO 10993-1:2009 and EN ISO 7405:2008.
8. The sample size for the training set
This information is not applicable/not provided. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, no training set for an algorithm is involved.
Summary of what can be gleaned from the document:
The primary "study" mentioned for Monobond® Etch & Prime is laboratory testing for tensile bond strength and biocompatibility. The purpose of these tests was to demonstrate substantial equivalence to the predicate device, Monobond Plus (K090826).
- Tensile bond strength on glass ceramics was tested and found to conform to specification and be "substantially equivalent" to the predicate. The methods for the new device were tensile bond strength, while the predicate historically used shear bond strength, making direct comparison difficult, but a specific comparison was still made for tensile bond strength to show equivalence.
- Biocompatibility was assessed according to EN ISO 10993-1:2009 and EN ISO 7405:2008.
The document is a regulatory submission for a Class II medical device, and as such, it emphasizes comparison to a predicate device and adherence to regulatory standards rather than presenting detailed clinical trial data or comprehensive study results with explicit, quantifiable acceptance criteria and multi-reader analyses typical for diagnostic AI devices.
§ 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.