(131 days)
HygePLUS Alginate Impression Material is irreversible hydrocolloids for dental Impressions used by the dentist to take the anatomical data of the patient's mouth. The device is Intended to provide models for study and for production of restorative prosthetic devices, such as gold Inlays and dentures.
HygePLUS Alginate Impression Material is a alginate impression material for general dental practice and for orthodontics. It is presented in the form of a homogeneous yellow powder with spearmint flavour.
The provided text describes a 510(k) premarket notification for an alginate impression material, not an AI-powered device. Therefore, much of the requested information regarding AI models, such as sample sizes for training and test sets, multi-reader multi-case studies, and ground truth establishment methods for AI, is not applicable.
However, I can provide information based on the performance testing conducted for this device, which focuses on physical properties compared against an established standard.
1. Table of Acceptance Criteria and Reported Device Performance:
| Physical Parameters | Acceptance Criteria (ADA18 Requirements) | Reported Device Performance (HygePLUS Alginate Impression Material K170812) |
|---|---|---|
| Compatibility with gypsum | 0-50μm | complies |
| Elastic recovery | > 95% | 97.4% |
| Strain in compression | 5-20% | 16% |
| Compressive strength | > 0.35MPa | 1.00 MPa |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for testing each physical parameter. The testing was conducted internally by the manufacturer (Hygedent Inc.) to validate and verify that the proposed device met design specifications. The data provenance is from the manufacturer's performance 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 "ground truth" for this device is based on performance against established industry standards (ADA Spec No.18), not on expert consensus of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable. The performance was measured objectively against quantitative 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 is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered device.
7. The type of ground truth used:
The ground truth used for evaluating the device's performance was the ADA Spec No.18 recommendations for alginate impression materials. This constitutes established industry standards for physical properties.
8. The sample size for the training set:
Not applicable. This is not an AI-powered device and therefore does not have a training set in that context.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI-powered device. The "ground truth" for the performance tests was established by industry standards (ADA Spec No.18).
§ 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).