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510(k) Data Aggregation
(76 days)
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. The Dental Impression Material is very easy to mix and has good dimensional stability, helps to make precise impression taking.
The provided document describes the acceptance criteria and a study for the Nanchang Dental Bright Technology Co., Ltd's Dental Impression Material.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Type 0) | Reported Device Performance | Result |
|---|---|---|---|
| Consistency | < 35mm | 32 mm | PASS |
| Compatibility with gypsum | < 75 um | Complied | PASS |
| Detail Reproduction | < 75 um | Complied | PASS |
| Linear dimensional change % | < 1.5 | 0.72 | PASS |
| Elastic recovery | ≥ 96.5% | 98.23% | PASS |
| Strain in compression % | 0.8 ~ 20% | 4.41 | PASS |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each of the physical property tests. It mentions that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or similar to the predicate device." The data provenance is not specified in terms of country of origin, nor whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical study evaluating the physical properties of a dental impression material, not a study involving human or image-based ground truth established by experts. The ground truth for these tests is defined by the standards (ISO 4823) and the quantitative acceptance criteria.
4. Adjudication method for the test set:
Not applicable, as this is a non-clinical study measuring physical properties against established 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. This document pertains to the physical properties of a dental impression material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a non-clinical study for a medical device (material), not an algorithm.
7. The type of ground truth used:
The ground truth used for this study is based on established international standards for dental elastomeric impression materials, specifically ISO 4823. The acceptance criteria are quantitative measurements derived from these standards.
8. The sample size for the training set:
Not applicable. This is a non-clinical study assessing the physical properties of a material, not a machine learning model that requires 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 non-clinical physical property evaluation.
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