(47 days)
- Bonding between dentin/enamel and composite filling materials
- Bonding between dentin/enamel and compomer filling materials
- Intraoral repair of porcelain, composite, and metal using light-cure composite resin.
- Desensitization of hypersensitive teeth, root surface desensitization
SEA2 Self-etch adhesive is a simple to use, two-bottle, self-etch bonding adhesive with bottle A containing the aqueous primer and bottle B containing the acidic adhesive. This delivery design is common to many of the predicate devices as noted in the submission. The primer contains a color indicator which indicates complete coverage of the preparation. The color disappears upon addition of the adhesive, indicating activation of the acid and insuring that a proper etch is taking place.
The provided text describes a 510(k) submission for the SEA2 Self-Etch Adhesive, a dental device. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific quantitative acceptance criteria or reporting detailed performance against such criteria. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be found in the provided document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established/Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | "The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405." |
| Performance (Adhesion to Dentin and Enamel) | "The performance testing includes adhesion to dentin and enamel. The test results provided in the submission confirm the performance as substantially equivalent to the predicate devices with common indications." |
| Substantial Equivalence to Predicate Devices | "The chemical composition is similar to predicate self-etch adhesive devices." |
| "The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405." | |
| "The test results provided in the submission confirm the performance as substantially equivalent to the predicate devices with common indications." |
Missing Information:
- Specific quantitative acceptance criteria (e.g., minimum bond strength in MPa, maximum cytotoxicity thresholds).
- Detailed quantitative performance results (e.g., actual bond strength values, specific cytotoxicity assay results).
- Details on "common indications" where performance was confirmed.
2. Sample size used for the test set and the data provenance
Missing Information:
- The document does not specify the sample size used for performance testing (e.g., how many teeth or samples were tested for adhesion).
- The data provenance (e.g., country of origin, retrospective or prospective) for the test set is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable/Missing Information:
- This type of information is typically relevant for diagnostic devices where "ground truth" might be established by expert interpretation of images or clinical findings. For a dental adhesive, ground truth is established through laboratory performance testing (e.g., bond strength measurements, biocompatibility assays) rather than expert consensus on interpretations. The document does not mention human experts establishing ground truth for the test set.
4. Adjudication method for the test set
Not Applicable/Missing Information:
- Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies. For laboratory performance testing of a dental adhesive, this concept does not apply.
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
Not Applicable:
- MRMC studies are relevant for diagnostic devices, especially those involving AI for image interpretation. This device is a dental adhesive, and no AI component or human reader interpretation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable:
- This pertains to AI algorithms. The SEA2 Self-Etch Adhesive is a physical dental bonding agent, not an AI algorithm.
7. The type of ground truth used
- For Biocompatibility: Ground truth was established through biocompatibility assessment based on ISO10993 and ISO 7405. This implies specific laboratory tests and their established pass/fail criteria according to these international standards.
- For Performance (Adhesion): Ground truth was established through adhesion testing to dentin and enamel. This would involve laboratory measurements of bond strength, likely against established benchmarks or in comparison to predicate devices.
Missing Information:
- Specific details of the ground truth (e.g., what specific ISO tests were performed, the exact lab methods for adhesion testing, specific numerical thresholds).
8. The sample size for the training set
Not Applicable/Missing Information:
- The concept of a "training set" is primarily relevant for machine learning or AI algorithms. For a conventional medical device like a dental adhesive, there isn't a "training set" in this context. Product development and formulation might involve iterative testing, but it's not described as a "training set" with ground truth in the AI sense.
9. How the ground truth for the training set was established
Not Applicable/Missing Information:
- As explained above, there is no "training set" for this type of device in the context of AI or machine learning.
§ 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.