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510(k) Data Aggregation
(812 days)
Fabrication of temporary crowns, bridges, inlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
This product is ISO10477 Type 2 & Class 2, a light cured resin that forms the shape of a resin to make a temporary crown to protect the tooth for crown treatment for a certain period until the prosthesis is made. It is packaged in an impermeable syringe which is polymerized by light-cured energy and composed of base and photocatalytic agent.
The provided document is a 510(k) Pre-Market Notification for a dental device called CURA-Temp. It focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the information requested in your prompt is not available in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table between the subject device (CURA-Temp) and its predicate device (TempXN28, currently marketed as Protemp Plus). This table implicitly shows the acceptance criteria by listing the predicate device's performance thresholds, largely based on ISO 10477 standards.
| Item | Acceptance Criteria (based on Predicate/ISO 10477) | Reported Device Performance (CURA-Temp) |
|---|---|---|
| Depth of cure | $\geq$ 70% of top surface | 99 % |
| Flexural Strength | $\geq$ 50 MPa | Avg. 83.5 MPa |
| Water Sorption | $\leq$ 40 µg/mm³ | Avg. 19.4 µg/mm³ |
| Solubility | $\leq$ 7.5 µg/mm³ | Avg. 2.72 µg/mm³ |
| Color Stability | No more than a slight change | No a slight change in colour |
| Shade Consistency | No more than a slight difference | No a slight change in colour |
| Surface Finish | A glossy surface | A glossy surface |
| Biocompatibility | Compliance with EN ISO 10993-1 | Compliance with EN ISO 10993-1 |
Note: The "acceptance criteria" here are inferred from the predicate device's performance and the ISO 10477 standards that both devices are tested against. The CURA-Temp's performance clearly meets or exceeds these criteria.
2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The document refers to "non-clinical performance tests" and "biocompatibility tests" but does not specify sample sizes for these tests or the data provenance. Since it's a 510(k) submission, the data is likely from laboratory bench tests conducted by the manufacturer.
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. The document describes bench testing and biocompatibility testing, which typically do not involve human experts establishing ground truth in the way a clinical study or image interpretation study would.
4. Adjudication method for the test set
This information is not provided. As above, adjudication methods are typically relevant for human-involved evaluations (e.g., clinical trials, image interpretations), which are not detailed 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
This information is not applicable/provided. The CURA-Temp is a dental resin for temporary crowns, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The CURA-Temp is a physical medical device (dental resin) and does not involve algorithms or AI performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical performance tests (e.g., flexural strength, water sorption), the "ground truth" is established by physical measurements and adherence to international standards (ISO 10477). For biocompatibility, the "ground truth" is established by laboratory tests following ISO 10993 standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical diagnostic study.
8. The sample size for the training set
This information is not applicable/provided. This device is a physical product and does not involve AI or machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no "training set" for this type of device.
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