(86 days)
- Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE-Step and some other fifth generation adhesives for use with light-cured composite materials
- Indirect Restorations: when used with an adhesive, to seal a preparation when using a light-cured composite cement.
- Densensitization: when used in combination with adhesive, to treat hypersensitive and/or exposed root surfaces.
A two bottle (or unit dose container), no rinse self-etching primer for use with light cured dental adhesives.
The provided document is a 510(k) premarket notification for a dental adhesive device named "SIMPLE." The document primarily focuses on establishing "substantial equivalence" to a predicate device, Clearfil™ SE BOND.
However, the document does not contain specific details about acceptance criteria, a formal study protocol, or performance metrics in a way that would allow for a comprehensive table and detailed answers to all the questions posed.
Here's an analysis of the available information and what cannot be answered from this document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance targets (e.g., bond strength thresholds, success rates). Instead, it relies on a qualitative comparison to the predicate device for "significant performance characteristics."
| Characteristic | Acceptance Criteria (Implicit) | Reported Performance (SIMPLE) | Predicate Performance (Clearfil SE BOND) |
|---|---|---|---|
| Intended Use | Substantially equivalent to predicate | Designed to reduce steps in preparing dentin and enamel for composite adhesion | Designed to reduce steps in preparing dentin and enamel for composite adhesion |
| Product Description | Substantially equivalent to predicate | One clear yellow solution; One white slurry | Two clear solutions |
| Delivery System | Substantially equivalent to predicate | Two solutions in separate bottles or in a two-chamber unit dose package | Two solutions in separate bottles package |
| Biocompatibility | Non-toxic | Biocompatibility tested; cytotoxicity and acute oral toxicity found to be non-toxic | (Not explicitly stated for predicate in this summary, but implicitly acceptable) |
Important Note: The "acceptance criteria" here are inferred to be "substantially equivalent to the predicate device" for the listed characteristics. No quantitative thresholds are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The document mentions "Side by side comparisons of SIMPLE to the predicate device," but does not detail the nature of these comparisons, the sample sizes, or the study design (retrospective/prospective, country of origin).
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 information is not provided. The document does not describe a process for establishing ground truth as it would for image-based diagnostic devices or complex clinical trials. The evaluation seems to be based on product characteristics and biocompatibility testing rather than expert-adjudicated clinical outcomes for the "test set" in the sense of a diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the "significant performance characteristics" described (intended use, product description, delivery system), a formal adjudication method as understood in clinical trials for diagnostic devices is unlikely to have been applied or documented in this summary.
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
An MRMC study is not applicable and not mentioned in this document. This typically applies to diagnostic devices where human readers interpret images or data, and AI assists in that interpretation. The "SIMPLE" device is a dental adhesive, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone algorithm" performance is not applicable and not mentioned. This device is a physical dental adhesive, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "significant performance characteristics" discussed, the "ground truth" seems to be based on:
- Manufacturer specifications and composition: for product description and delivery system.
- Biocompatibility testing results: for non-toxicity.
- Intended use statements: For comparison of application.
There is no mention of pathology, expert consensus on clinical outcomes, or large-scale outcomes data being used to establish "ground truth" for the performance comparison described.
8. The sample size for the training set
This information is not provided. The concept of a "training set" doesn't directly apply here, as this isn't an AI/machine learning device. If interpreted broadly as "samples used for development and preliminary testing," that information is not detailed.
9. How the ground truth for the training set was established
As in point 8, the concept of a "training set" and its "ground truth" establishment in the context of AI/ML is not applicable to this dental adhesive device.
Summary of what the document indicates:
The document serves as a 510(k) summary demonstrating "substantial equivalence" of the "SIMPLE" dental adhesive to a legally marketed predicate device, Clearfil™ SE BOND. The primary evidence presented for this equivalence is a side-by-side comparison of intended use, product description, and delivery system, alongside biocompatibility testing results for "SIMPLE." It does not provide the detailed study protocols, sample sizes, expert qualifications, or quantitative performance metrics typically associated with the questions asked, particularly those relevant to AI/diagnostic device evaluation.
§ 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.