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510(k) Data Aggregation
(436 days)
Micron Bioactive Class III and V. Restoration of cervical erosions and root surface caries, Core buildup. Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth
Micron Superior Shades A1. A2. A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup
Micron Superior Capsules Shades A1, A2, A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup
Micron Luting
Base/Liner
Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns
Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement
Micron Bioactive is a radiopaque, hydroxyapatite modified-glass ionomer cement.
Micron Superior is a radiopaque glass ionomer cement. It comes in shades A1, A2 and A3.
Micron Superior Capsules is a radiopaque glass ionomer cement. Capsules come in shades A1, A2 and A3.
Micron Luting is a radiopaque, self-curing translucent, particle glass-ionomer luting material.
Micron Dentin Conditioner is a mild polyacrylic acid solution designed to remove the dentinal smear layer and to condition dentine, thus enhancing the bond between glass ionomer cement and the dentine.
The document describes the Prevest Dental Cements, a line of dental materials including Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, and Micron Dentin Conditioner. The acceptance criteria and the study conducted to prove the device meets these criteria are detailed in the "Testing Summary" and comparison tables.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Prevest Dental Cements are based on ISO 9917-1. The study reports that all test results met the criteria in Table 1 of ISO 9917-1.
| Acceptance Criteria (based on ISO 9917-1) | Reported Device Performance (Prevest Dental Cements) |
|---|---|
| Appearance of powder and liquid | Met criteria in Table 1 of ISO 9917-1 |
| Opacity | Met criteria in Table 1 of ISO 9917-1 |
| Acid-soluble lead content | Met criteria in Table 1 of ISO 9917-1 |
| Setting time | Met criteria in Table 1 of ISO 9917-1 (Specific values provided for each product type in the comparison tables, e.g., Micron Bioactive: 1:30 – 2 min; Micron Superior: A1 3:30-3:35 min, A2 5:20-5:30 min, A3 3:15-3:20 min; Micron Luting: 2:30 min) |
| Compressive strength | Met criteria in Table 1 of ISO 9917-1 |
| Film thickness | Met criteria in Table 1 of ISO 9917-1 |
| pH (for Micron Dentin Conditioner) | Met criteria in Table 1 of ISO 9917-1 |
| Shelf life | 3 years (Met relevant protocols for physical characteristics) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only states that "Micron line products were tested" and "Shelf life testing was completed on all devices."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing was based on international standards (ISO 9917-1) for physical and chemical properties, not on expert clinical evaluation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided as the testing involved laboratory measurements against a standard, not human adjudication of subjective assessments.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for AI-powered diagnostic devices involving human interpretation, which is not the nature of these dental cements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. These are dental cements, not an algorithm or AI system. The "standalone" testing refers to the physical and chemical property tests performed on the materials themselves, without human interpretation as part of the performance metric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these dental cements is established by the specified physical and chemical properties outlined in ISO 9917-1. These are objective, measurable parameters (e.g., setting time, compressive strength, opacity) for dental materials.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device that requires a training set.
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