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510(k) Data Aggregation
(522 days)
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- Fabrication of long-lasting temporary restorations;
- Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.
The provided text is a 510(k) summary for the device PrimmaArt, a temporary crown and bridge resin. It describes the device, its indications for use, comparison with a predicate device (Structur 3), and non-clinical testing results.
However, the document does not contain information regarding a study involving human readers, ground truth establishment, sample sizes for test or training sets, or expert qualifications for AI/ML device performance analysis. The acceptance criteria and "device performance" in the context of this document refer to physical and chemical properties of the dental resin, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/ML device per the input prompt's structure. The device described, PrimmaArt, is a material, not a software or AI/ML device.
However, I can extract the acceptance criteria and reported device performance for the dental resin based on the provided tables:
1. Table of Acceptance Criteria and Reported Device Performance (for PrimmaArt dental resin):
| Test | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Setting time and heat released | Setting time: No more than 5 minutes (EN ISO 4049). Project target: 2'30" - 3'10". Heat released: Less than 0.60 mW/mg. | Setting time: 2m48s. Heat released: 0.30 mW/mg. (Product evaluated using DSC and presented results according to design input). |
| Viscosity | Base and catalyzer viscosity: Between 60000 and 100000 mPa.s (according to design input). | Base Paste: 92733 mPa.s. Catalyst paste: 90133 mPa.s. (Results within defined limits). |
| Surface Finish | Polymerized composite presents a reflective surface (ISO 10477). | Surface of specimen was reflective (in accordance with ISO 10477). |
| Shade consistency and color stability | No more than a small color change (EN ISO 4049 and ISO 7491). | Only a small color difference (acceptable according to ISO 4049) was attested in one comparison; no changes identified in other analyses. |
| Radiopacity | Value > 1.0 mm when compared to aluminum scale (ISO 4049). | 1.68 mm. (FGM Bisacrylic resin presented results above that specified by ISO 4049). |
| Flexing Resistance | Flexural strength ≥ 50MPa (ISO 10477). | 65.5 MPa. (All results within values specified in ISO 10477). |
| Water sorption and solubility | Sorption: Maximum of 40 µg/mm³. Solubility: Maximum of 7.5 µg/mm³ (ISO 4049). | Sorption: 9.389 ± 1.26 µg/mm³. Solubility: 1.542 ± 0.32 µg/mm³. (All results below within the specified limit). |
| Working time | At least 60 seconds (EN ISO 4049 for cementation materials). | More than 60 seconds. |
| Accelerated Stability Studies | Product should not show significant changes in physical-chemical properties after accelerated degradation (study created to accelerate degradation). | Did not show significant changes in terms of its physical-chemical properties during the accelerated stability process (225 days). |
| Long-Term Stability (Shelf) | Verify physical and chemical characteristics during expected shelf life to confirm expiration date. | No conclusive data about shelf life yet; estimated 2 years shelf life based on accelerated stability test. |
| Microhardness Vickers | Hardness (HV) between 5 and 15 HV, and similar or superior to competitor (Project Entry Requirements). | 11.81 HV. (All results within the specified limit). |
2. Sample size used for the test set and the data provenance:
- This information is not applicable as the study involves material testing, not an AI/ML algorithm or dataset. The tests are performed on samples of the PrimmaArt resin. The data provenance is DentsCare LTDA, Brazil, as the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device. Ground truth, in this context, refers to the adherence of the material's properties to international standards (e.g., ISO) and internal design inputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device evaluated by human readers. The assessment is based on direct measurement against established material performance standards.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device. The performance tests are for the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing of the dental resin, the "ground truth" or reference for acceptance is defined by recognized international standards (e.g., ISO 7491, ISO 10477, ISO 4049) and the device's internal design input specifications.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no concept of a "training set" for a dental resin material in this context.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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