(66 days)
Cavios® Cavity Liner is to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. Cavity Liner is indicated for use in the general dental population.
Cavios®, (shown in Figure 1) is a light cured single-component yellow-white paste for use as a dentin liner and base. The product is preloaded into syringes and expressed via the syringe plunger through single-use disposable tips. Following the application, Cavios® is cured (polymerized) with a light source (approximately 470 nm). Following polymerization, the restorative materials, amalgam, etc., may be placed. Cavios® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.
The provided text does not contain information about acceptance criteria for a device's performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on the safety and material properties of the "Cavios Cavity Liner." The studies described are non-clinical (biocompatibility and bench testing) and do not involve a test set of patient data, ground truth establishment, or expert readers in the context of diagnostic performance.
Therefore, many of the requested sections about acceptance criteria, study design for diagnostic performance, ground truth, and expert involvement cannot be addressed from the given document.
Here's an analysis of the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here pertain to the biocompatibility and material characteristics established through recognized consensus standards rather than diagnostic performance.
| Acceptance Criteria (Test Standard) | Reported Device Performance (Result) |
|---|---|
| Biocompatibility: | |
| ISO 10993-3 (Genotoxicity) | Negative |
| Hemolysis | Cavios was tested for Hemolysis both directly and as extracts. Test article induced 0.1% to 2.8% hemolysis. Cavios is considered negative in this assay. |
| ISO 7405 6.2/6.3, ISO 10993-5 (Cytotoxicity) | Not cytotoxic to cultured L929 mouse fibroblast cells after a 24-hour exposure. |
| ISO 10993-10 (Sensitization) | Possible mild sensitizer (sensitization rate: 24 hr – 20% and 48 hr – 20%). Note: This result indicates a potential non-compliance with a strict "negative" acceptance, but the document states they believe there are no biocompatibility issues due to widespread use and no adverse reports. |
| Material Properties (ISO 4049:2000): | |
| Depth of Cure | 1.4 mm |
| Flexural Strength | 59.9 Mpa |
| Water Sorption | 33. µg/mm³ |
| Solubility | -0.8 µg/mm³ |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The tests are for material properties and biocompatibility, not diagnostic performance on a patient data test set. Biological tests used laboratory samples (e.g., bacterial strains, rabbit whole blood, mouse fibroblast cells, guinea pigs).
- Data Provenance: The biocompatibility tests were conducted by Covance in 2002. The material properties tests are reported without specific lab or date, but under the context of "recognized consensus standards and other testing." This is non-clinical, laboratory-based data for materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information pertains to studies assessing diagnostic accuracy, which is not what is reported here. The "ground truth" for these tests are the established scientific methods and pass/fail criteria for material properties and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This information pertains to studies assessing diagnostic accuracy, which is not what is reported here.
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
- No. This is a medical device (cavity liner) and not an AI/diagnostic imaging product, so an MRMC study is not relevant or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The device is a physical material (cavity liner), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on the established scientific endpoints and methodologies of each specific test (e.g., whether bacterial growth is inhibited, percentage of hemolysis, cell viability, mechanical property measurements).
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of device material testing or safety assessments.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.