(53 days)
to reproduce the structure of a patient's teeth and gums ... to provide models for study and for production of restorative prosthetic devices
TriPhasix Chromatic Alginate may be described as a vanilla flavored alginate impression which changes color from violet to pink to white to indicate completion of mixing, appropriate consistency for tray loading and appropriate consistency for impressioning, respectively. Slight alteration of water-to-powder ratios will deliver "heavy", "medium", or "light" body mixtures as preferred by the user.
This document is a 510(k) summary for a dental impression material (Parkell TriPhasix Chromatic Alginate). It outlines the product's description, intended use, and equivalence to other similar devices. However, this type of submission does not typically include detailed performance study data in the way that an AI/software as a medical device (SaMD) submission would.
Therefore, many of the requested categories related to clinical study design, ground truth, expert adjudication, and AI performance metrics will not be applicable or available in this document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 1563/1990 for Alginate Compliance | Complies with ISO 1563/1990 for Alginate |
| Hazardous Materials | Contains no hazardous materials |
| Mixing Time | 45 seconds |
| Total Working Time | 2 minutes 25 seconds |
| Compatibility with Dental Model Gypsum | Compatible with dental model gypsum |
| Detail Reproduction | Reproduces 50 micron detail |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a physical medical device (alginate impression material), not a software or AI device that would typically involve a "test set" in the context of diagnostic performance evaluation. The compliance with ISO 1563/1990 would involve testing according to the standard's defined methods, which may include physical property tests (e.g., tear strength, dimensional stability), but these are not specified as a "test set" in the context of clinical or AI performance. The document does not provide details on the number of samples or data provenance for the ISO compliance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. The "ground truth" for this device would be its physical and chemical properties as measured against the ISO standard, and its ability to accurately reproduce dental structures. This is assessed via standardized physical testing, not expert interpretation of outputs for a diagnostic task.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/SaMD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established by the specifications and test methods defined in ISO 1563/1990 for Alginate impression materials. Other "ground truths" include objective measurements of physical properties like mixing time, working time, compatibility with gypsum, and detail reproduction (e.g., using a standardized test block or gauge).
8. The sample size for the training set
- Not Applicable. This is not an AI/SaMD device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/SaMD device.
§ 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).