(128 days)
Hygedent 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.
Hygedent Alginate Impression Material is a dust free alginate impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a homogeneous orange colored powder with a nice mint flavor. The material has exceptional good elastic properties and a high tear-resistance. The impression surface is very smooth, which gives excellent gypsum compatibility.
This document describes the acceptance criteria and the study conducted for the Hygedent Alginate Impression Material.
1. Table of Acceptance Criteria and Reported Device Performance:
The document compares the physical parameters of the proposed device (Hygedent Alginate Impression Material) against a predicate device. While specific "acceptance criteria" for each parameter are not explicitly stated as numerical thresholds, the comparison itself implies that the proposed device must perform comparably to the predicate device.
| Physical Parameters | Proposed Device Performance | Predicate Device Performance | Implied Acceptance Criteria (relative to Predicate) |
|---|---|---|---|
| Appearance | Powder | Powder | Must be Powder |
| Odor | Peppermint | Peppermint | Must be Peppermint |
| Compression strength | 0.75 MPa | 0.7 MPa | Must be similar (0.75 MPa is close to 0.7 MPa) |
| Compatibility with gypsum | 50 μm | 50 μm | Must be 50 μm |
| Recovery from Deformation | 96.50 % | 96 % | Must be similar (96.50% is close to 96%) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" and thus no sample size for it. The performance data presented (in the table above) appears to be from non-clinical testing conducted by the manufacturer. The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective, beyond being generated for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The study did not involve human experts establishing ground truth for a test set. The evaluation was based on physical property measurements against a predicate device and established standards.
4. Adjudication Method for the Test Set:
Not applicable. There was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a material science study, not an AI or diagnostic imaging study involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is an impression material, not a software algorithm that performs diagnostic tasks. The performance evaluation focuses on the material's physical properties.
7. Type of Ground Truth Used:
The "ground truth" for this study was based on:
- Physical property measurements: Direct measurements of the material's characteristics (compression strength, compatibility with gypsum, recovery from deformation).
- Comparison to a predicate device: The predicate device served as a benchmark for "substantially equivalent" performance.
- Compliance with international standards: ISO 1563:1990 and ADA Specification No.18.1992 were used as benchmarks for acceptable performance.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 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).