(199 days)
Image Alginate Dental Impression materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or chectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Alginate impression materials are elastic, irreversible hydrocolloid impression materials made from seaweed. They are used to take primary or preliminary impressions of a patient's teeth and gums. This colloidal material forms a gel when the powder is mixed with water. It solidifies into an elastic mass capable of producing a negative reproduction of the oral cavity (an impression). Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. They are also used to fabricate bleaching trays and mouth guards. Alginate is the most universally utilized impression material in dentistry. Image Alginate is a green-colored, mint flavored alginate and comes in two options Regular Set, Fast Set. The packaging configurations include a 1 lb. (454 g) bag and a singles pack of 18 g.
The document is a 510(k) Premarket Notification for "Image Alginate Dental Impression Materials" (K160097). It details the substantial equivalence of the proposed device to predicate devices (Identic Alginate and KromaFaze Alginate, K160441).
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against the ISO 1563:1990 standard for Dental Elastic Impression Materials Part 2 Alginate dental impression material. The acceptance criteria are essentially the "Pass" values defined by this standard.
| Element (Acceptance Criteria per ISO 1563) | Reported Device Performance (Image Alginate) |
|---|---|
| Mixing time | Pass 30" |
| Working time (Regular Set) | Pass 2'20" |
| Working time (Fast Set) | Pass 1'45" |
| Setting time (Regular Set) | Pass ≤3'30" |
| Setting time (Fast Set) | Pass ≤2'20" |
| Homogeneous Mixed Material | Pass |
| Compatibility with gypsum and reproduction of detail (50 µm line) | Imparts a smooth surface to, and separates cleanly from, a gypsum cast. Impression reproduces 50 µm line. Pass |
| Recovery from deformation (%) | ≥95% Pass |
| Compressive strength | ≥0.35 MPa Pass |
| Dimensional Changes at 100 hours | ≤ 2% when compared to a Mold Pass |
| Material Compatibility (Biocompatibility) | Biocompatibility meets requirements |
| Shelf Life | 24 months based on real time data |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical performance test. It broadly mentions "Non-clinical performance data included testing for Work time, Dimensional Changes, Set Time, Mixing Time... etc." The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, beyond stating that "Biocompatibility testing was performed at a third party laboratory."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described studies are non-clinical, laboratory-based performance tests and biocompatibility assessments, not studies involving human interpretation or clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing has not been performed for Image Alginate Dental Impression Materials."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a dental impression material, not an AI algorithm. The performance evaluation is for the material's physical and chemical properties.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" (or reference standard) is established by the ISO 1563:1990 standard for Dental Elastic Impression Materials Part 2 Alginate dental impression material. For biocompatibility, the ground truth is against ISO 10993-1:2009 and ISO 10993-5:2009 Biological Evaluation of Medical Devices. There is no mention of pathology or outcomes data as it is a non-clinical evaluation of a material.
8. The Sample Size for the Training Set
This is not applicable as the device is a material, not a machine learning model, and therefore does not have a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 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).