(280 days)
Apacal ART and is suitable for several indications including:
- · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
- · Indirect pulp capping or management of deep caries lesions, or
- · Direct pulp capping
CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.
Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including;
- · Indirect pulp capping or management of deep caries lesions, or
· Direct pulp capping
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips.
CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips.
Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips.
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.
The provided text describes the substantial equivalence of Prevest Denpro Cavity Liners to predicate devices, focusing on physical parameters and material composition rather than AI performance. Therefore, many of the requested categories related to AI studies and expert review are not applicable to this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests results met the criteria in standards." The acceptance criteria are implicit in the ISO and USP standards referenced for each test. The performance is reported as meeting these standards.
| Device Name | Test | Standard Reference (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Apacal ART & Cal LC | Appearance | ISO 9917-2:2017, ISO 4049:2019, ISO 13116:2014 | Met standards |
| Flexural Strength | ISO 9917-2:2017 (e.g., for Apacal ART: 99.1 MPa; for CAL-LC: 96.3 MPa) | Met standards | |
| Depth of Cure | ISO 4049:2019 | Met standards | |
| Water Sorption | ISO 4049:2019 (e.g., for Apacal ART: 13.6 µg/mm³; for CAL-LC: Data not specified but implied to meet standards) | Met standards | |
| Water Solubility | ISO 4049:2019 (e.g., for Apacal ART: 4.5 µg/mm³; for CAL-LC: Data not specified but implied to meet standards) | Met standards | |
| Radio-opacity | ISO 13116:2014 | Met standards | |
| Calcigel | Appearance | ISO 6876:2012 | Met standards |
| Flow | ISO 6876:2012 | Met standards | |
| pH | USP 971 (e.g., 11-13) | Met standards | |
| Radio-opacity | ISO 13116:2014 | Met standards | |
| CalUltra | Appearance | ISO 9917-1:2017 | Met standards |
| Compressive Strength | ISO 9917-1:2017 | Met standards | |
| Water Solubility | ISO 6876:2012 (e.g., 3.8%) | Met standards | |
| Setting Time | ISO 6876:2012 (e.g., 1-3 minutes) | Met standards | |
| Radio-opacity | ISO 13116:2014 | Met standards | |
| pH | USP 971 (e.g., 9.2) | Met standards | |
| All Devices | Shelf Life | Relevant protocols (not specified in detail, but implied to meet standards) | 3 years |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the testing of these physical and chemical properties. The data provenance is presumed to be from the manufacturer's testing conducted in India (Prevest Denpro Limited, Jammu, India). The testing is described as being performed "according to protocols based on" relevant ISO and USP standards, indicating manufacturer-conducted in vitro/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device clearance based on material properties and performance against established international standards, not an AI or diagnostic device requiring expert ground truth for image interpretation or similar tasks.
4. Adjudication method for the test set
Not applicable. This type of adjudication is typically used in clinical or image-based studies. The "adjudication" here is the assessment against specified ISO/USP standard requirements.
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. The device is a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a dental material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is based on the objective measurements against established international and national standards (ISO and USP) for material properties (e.g., flexural strength, depth of cure, water sorption/solubility, pH, setting time, radio-opacity).
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.