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510(k) Data Aggregation
(139 days)
VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.
The provided text is a 510(k) summary for a dental impression material. The document demonstrates substantial equivalence to predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study details and expert adjudication is not present in this document.
However, I can extract the acceptance criteria and performance data for the device based on the non-clinical performance tests presented.
Here's the information derived from the document:
1. A table of acceptance criteria and the reported device performance
| Physical Parameters | Acceptance Criteria (Standard ISO4823) | Reported Device Performance (K191034) |
|---|---|---|
| Consistency | ≤35mm | 31 mm |
| Working time | ≥1'30" | 2' |
| Detail reproduction | 50μm | complies (implicitly meets 50μm) |
| Linear dimensional change | ≤1.5% | 0.16% |
| Compatibility with gypsum | 50μm | complies (implicitly meets 50μm) |
| Elastic recovery | ≥96.5% | 99.06% |
| Strain-in-compression | >0.8% <20% | 2.73% |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each physical property test. The data provenance is also not specified in terms of country of origin or whether the tests were retrospective or prospective, beyond indicating and referencing the ISO 4823 standard, which implies laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study involves non-clinical performance testing against a standard (ISO 4823), not clinical evaluation requiring expert consensus for ground truth.
4. Adjudication method for the test set
This information is not applicable for non-clinical performance testing.
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
No such study was conducted or is mentioned in the document. This is a material science characterization for a dental impression product, not an AI-assisted diagnostic or treatment device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical impression material, not an algorithm.
7. The type of ground truth used
The ground truth or benchmark used for the performance tests is the ISO 4823:2015 standard for dental elastomeric impression materials.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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