(162 days)
to obtain the structure of a patient's teeth and gums
Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of whatever surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly.
To create the material, the user simply mixes the base with the catalyst, and the chemical reaction begins. Once the impression material is set and slightly modified, it is taken to patient's mouth for use in the transfer bonding process.
The provided text describes a 510(k) summary for the Sildent Fast Light Body, Sildent Fast Heavy Body, and Sildent Bite dental impression materials, which are vinyl polysiloxane elastomers. This document does not detail a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance, but rather focuses on substantial equivalence to predicate devices based on technological characteristics and non-clinical performance (biocompatibility).
Therefore, many of the requested fields cannot be filled as they pertain to clinical performance studies typically seen with AI/ML devices or diagnostic tools. However, I can extract information related to the acceptance criteria (performance properties) and the non-clinical studies conducted.
Here's an analysis based on the provided text, addressing the relevant points where information is available:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the applicable standard ISO 4823 and by comparison to the predicate device's performance.
| Performance Characteristic | Acceptance Criteria (from ISO 4823 or Predicate) | Sildent Fast Heavy Body Reported Performance | Sildent Fast Light Body Reported Performance | Sildent Bite Reported Performance |
|---|---|---|---|---|
| Recovery from deformation | > 96.5% (ISO 4823) | > 96.5% | > 96.5% | N/A |
| Strain in compression | 20 HD (DIN 13903) or 95 Shore A | > 20 HD | N/A | > 20 HD |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "appropriate study" for non-clinical performance but does not specify sample sizes for these tests. The company location is HRS Co., Ltd. in Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as this is not a study requiring expert-established ground truth for diagnostic or AI/ML performance. The "ground truth" for material properties is based on standardized physical and chemical tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as this is not a study requiring expert 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
This information is not applicable. This submission concerns dental impression materials, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This submission concerns dental impression materials, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance properties (recovery from deformation, strain in compression, linear dimensional change, working time, intraoral setting time, hardness) is based on physical and chemical measurements performed according to ISO 4823 and DIN 13903 standards.
8. The sample size for the training set
This information is not applicable as there is no training set mentioned; this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned; this is not an AI/ML device.
In summary, the provided document focuses on demonstrating substantial equivalence of dental impression materials to predicate devices based on adherence to international standards (ISO 4823, DIN 13903) for physical properties and biocompatibility studies (ISO 10993). It does not contain information related to clinical performance studies, AI/ML device evaluation, or diagnostic accuracy.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).