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510(k) Data Aggregation
(138 days)
JUELLCure Soft is intended for use as a permanent soft relining for total and partial dentures
- . To relieve pressure from pressure points
- To dam the palatal vibrating line ●
- . In cases of flabby ridge and/or insufficient adhesion
- . To cushion sharp-edged alveolar processes
JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
The provided text describes the 510(k) summary for the JUELLCure Soft device, which is a soft impression material for dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel SC.
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for JUELLCure Soft are based on demonstrating equivalence to the predicate device, Ufi Gel SC, across chemical composition and key physical properties.
| Test Item | Acceptance Criteria (Equivalent to Ufi Gel SC) | JUELLCure Soft Performance |
|---|---|---|
| Monomer Matrix (Base) | 70-80 % | 70-80 % |
| Rheologic Modifier (Base) | 15-30 % | 15-30 % |
| Catalyst (Base) | 0.1-0.5 % | 0.1-0.5 % |
| Colorant (Base) | <0.1 % | <0.1 % |
| Co-Monomer (Base) | 5-10 % | 5-10 % |
| Monomer Matrix (Glazing Base) | 80-90 % | 80-90 % |
| Rheologic Modifier (Glazing Base) | 10-20 % | 10-20 % |
| Catalyst (Glazing Base) | 0.1-0.5 % | 0.1-0.5 % |
| Monomer Matrix (Glazing Catalyst) | 60-70 % | 60-70 % |
| Rheologic Modifier (Glazing Catalyst) | 20-30 % | 20-30 % |
| Stabilizer (Glazing Catalyst) | 8-15 % | 8-15 % |
| Monomer Matrix (Entire mix, likely) | 70-85 % | 70-85 % |
| Rheologic Modifier (Entire mix, likely) | 15-20 % | 15-20 % |
| Stabilizer (Entire mix, likely) | 0.1-0.5 % | 0.1-0.5 % |
| Co-Monomer (Entire mix, likely) | 2-5% | 2-5% |
| Surface hardness (Shore hardness A) | 26.3 | 26.3 |
| Adhesion to dentures | 190 N | 190 N |
| Working time | 201 s | 201 s |
Study Proving Device Meets Acceptance Criteria:
The study described is a bench testing comparison of the JUELLCure Soft with the predicate device, Ufi Gel SC. The stated goal is to demonstrate "substantial equivalence" based on "indications, composition, and testing results."
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for the bench tests (surface hardness, adhesion, working time). It only provides the resulting performance values. It does not mention any clinical test sets with patient data. The data provenance is implied to be from the manufacturer's internal testing. There is no information about country of origin or whether it's retrospective or prospective, as it's a materials science test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a material, and its performance is evaluated through physical and chemical testing, not by expert interpretation of patient data. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on objective material property measurements, not subjective interpretation requiring adjudication.
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. This is a material for dental use, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the chemical composition, the ground truth is the chemical analysis of the material and its components. For the physical properties (surface hardness, adhesion, working time), the ground truth is the objectively measured value obtained through standardized testing methods, comparing it directly to the reported values of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a medical device material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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