(106 days)
- Direct-placed light-curing composite and compomer restorations.
- Direct-placed core build-ups with light-, self- and dual-curing composites.
- Repair of fractured composite and compomer restorations.
– Adhesive cementation of indirect restorations with light- and dual-curing luting composites. - Sealing of prepared tooth surfaces before temporary / permanent cementation of indirect restorations.
- Desensitization of hypersensitive cervical areas.
Adhese® Universal is a light-curing single-component dental adhesive for enamel and dentin.
The provided text describes the 510(k) summary for the Adhese® Universal dental adhesive. It details its comparison to a predicate device, its intended use, technological characteristics, and testing summary. However, it does not provide detailed acceptance criteria and a study report with the level of detail requested in the prompt, especially for AI/ML device testing.
Here's an analysis based on the information available, and highlighting what is missing in the context of an AI/ML device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (3M Adhesive EXL 759 (K110302)) | "The comparison shows that Adhese Universal is substantially equivalent to the predicate device." |
| Shear bond strength to dentin and enamel | "the results from testing demonstrate that Adhese Universal is substantially equivalent to the predicate device." |
| Biocompatibility | "Biocompatibility testing and evaluation was also carried out according to ISO 10993." (Implied acceptance, no specific result given beyond completion of test) |
Missing Information (Crucial for AI/ML devices): Specific quantitative thresholds for "substantial equivalence" regarding shear bond strength or other performance metrics. The document only states that it was found to be substantially equivalent without detailing how that was determined or the specific numerical results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The document mentions "standard shear bond strength method (see ISO 29022 for sample preparation)" but does not specify the number of samples tested for Adhese Universal or the predicate device.
- Data Provenance: Not specified.
Missing Information (Crucial for AI/ML devices): The number of individual teeth or samples tested for bond strength, and their origin (e.g., human cadaveric teeth, bovine teeth, specific age groups, etc.).
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 section is not applicable to this device. Adhese® Universal is a dental adhesive, not an AI/ML diagnostic or predictive device that relies on expert interpretation for ground truth. Its performance is measured through physical/mechanical properties like shear bond strength and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to this device, as it's not an AI/ML device requiring expert adjudication of results. The testing method appears to be laboratory-based physical testing.
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 section is not applicable to this device, as it's not an AI/ML device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable to this device, as it is a physical dental adhesive, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the direct measurements from laboratory tests:
- Shear bond strength: Measured values (e.g., in MPa) obtained from mechanical testing according to ISO 29022.
- Biocompatibility: Results from tests performed according to ISO 10993 (e.g., cytotoxicity, sensitization, irritation indices).
8. The sample size for the training set
This section is not applicable as this is not an AI/ML device and therefore does not have a training set. The "development" would involve chemical formulation and iterative testing, not machine learning model training.
9. How the ground truth for the training set was established
This section is not applicable as this is not an AI/ML device and therefore does not have a training set.
Summary for the provided device in terms of AI/ML criteria:
The provided document describes a dental adhesive (Adhese® Universal), which is a physical material, not an AI/ML device. Therefore, most of the questions related to AI/ML specific testing (such as ground truth establishment by experts, adjudication methods, MRMC studies, training sets, etc.) are not applicable.
The study described (testing for shear bond strength and biocompatibility) is a laboratory-based study comparing the new device against a predicate device to establish substantial equivalence based on physical and biological properties, not cognitive performance. The acceptance criteria are implicitly that the device performs equivalently to the predicate device in these tests. The specific numerical data from these tests is not provided in this summary.
§ 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.