(86 days)
AIM2 is a silicone impression material for taking oral impressions.
AIM2 is a VPS silicone impression material. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. AIM2 is available in one viscosity. The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
This document describes the premarket notification (510(k)) for the dental impression material AIM2. It focuses on demonstrating that AIM2 is substantially equivalent to a predicate device, EXAFLEX/EXAMIX Impression Material (K955932).
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria mentioned are the specifications outlined in ISO 4823. The document states that the device conforms to these required specifications.
| Acceptance Criterion (ISO 4823) | Reported Device Performance (AIM2) |
|---|---|
| Linear dimensional change (as per ISO 4823 specification) | Meets the specification set in ISO 4823 |
| Elastic recovery (as per ISO 4823 specification) | Meets the specification set in ISO 4823 |
| Strain-in compression (as per ISO 4823 specification) | Meets the specification set in ISO 4823 |
| Biocompatibility (as demonstrated by predicate device's data) | Biological safety test data shows the biocompatibility of the predicate device |
| Curing mechanism (addition silicone reaction) | Addition silicone reaction (vinyl polysiloxanes and poly-me,-siloxanes hydrogen terminated) |
| Setting time in mouth (a technical characteristic, not an "acceptance criterion" per se, but a key performance parameter) | 3 minutes |
Note: The document explicitly states: "Results of benchtop testing indicate the physical properties such as linear dimensional change, elastic recover and strain-in compression met the specification set in ISO 4823." This is the direct evidence of meeting the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size used for the benchtop tests.
- Data Provenance: The tests were "benchtop testing," which implies laboratory testing. The country of origin of the data is not specified, but the manufacturer is GC Corporation. The study is not a clinical trial, so the terms "retrospective" or "prospective" are not applicable in this context.
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 study is a benchtop performance test against international standards (ISO 4823), not a study requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable for a benchtop performance test.
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. The device is an impression material, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical impression material, not an algorithm.
7. The Type of Ground Truth Used:
For the performance tests, the "ground truth" or reference standard was the specifications outlined in ISO 4823. For biocompatibility, the document refers to the biological safety test data of the predicate device.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical material and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as the device does not involve a 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).