(5 days)
Used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL is a two-part catalyst/base hydrophilic vinylpolysiloxane impression material. It is formulated for regular set and fast set. This impression material is an extra low viscosity and is available in (1:1 ratio) cartridges.
The provided text is a 510(k) summary for a dental impression material, "AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL." It outlines the device description, intended use, technological characteristics, and biocompatibility testing. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML device evaluations.
This document describes a conventional medical device (impression material) rather than a software or AI/ML device that would require performance metrics like sensitivity, specificity, or reader studies. Therefore, many of the requested categories (sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to the information provided.
The "study" mentioned here refers to biocompatibility testing and a comparison to a predicate device to establish substantial equivalence, not a clinical trial evaluating diagnostic accuracy or AI model performance.
Here's an attempt to address the request based on the limited and non-AI/ML nature of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, explicit, quantifiable acceptance criteria and their corresponding reported performance values for a diagnostic/AI outcome are not present. The document focuses on biocompatibility and equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity (uncured material) | Passed biocompatibility testing |
| No cytotoxicity (cured material) | Passed biocompatibility testing | |
| No mutagenicity (cured material) | Passed biocompatibility testing | |
| No irritation (cured material) | Passed biocompatibility testing | |
| No sensitization (cured material) | Passed biocompatibility testing | |
| Material Equivalence | Components used in legally marketed devices OR found safe for use | All components have been used in legally marketed devices or were found to be safe for use. |
| Intended Use Equivalence | Same indications for use as predicate device | Indications for Use are the same as previously cleared for Aquasil XLV™ Smart Wetting Impression Material (K973782). |
| Technological Characteristics | Represents a modification to predicate material (K943754) | "AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL represents a modification to Aquasil XLV Smart Wetting Impression Material (K943754)." - No specific performance metrics or thresholds are presented, rather an assertion of a modification. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the document describes a physical dental impression material, not a software device evaluated on a test set of data. The "testing" mentioned refers to laboratory biocompatibility assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a diagnostic AI model is not relevant here. Biocompatibility testing is conducted in laboratory settings often following ISO standards, and the interpretation of results would be by qualified lab personnel.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is relevant for evaluating the impact of AI assistance on human readers for diagnostic tasks. This device is an impression material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. Not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the biocompatibility testing would be the established safety profiles and toxicological standards (e.g., ISO 10993 series) used to determine if the material exhibits cytotoxicity, mutagenicity, irritation, or sensitization. For material composition, the ground truth is the chemical composition and the regulatory history of the components.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of the "Study" (Biocompatibility & Equivalence Justification):
The "study" or evidence provided in this 510(k) pertains to:
- Biocompatibility Testing: The uncured and cured forms of AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL were evaluated.
- Uncured Material: Passed testing for cytotoxicity.
- Cured Material: Passed testing for cytotoxicity, mutagenicity, irritation, and sensitization.
- Component Safety: Asserts that all components have either been used in legally marketed devices or were found to be safe for use.
- Substantial Equivalence to Predicate Device (K973782):
- The device "represents a modification" to the Aquasil XLV Smart Wetting Impression Material (K943754), implying compositional or property changes that are still within acceptable safety and performance bounds as established by the predicate.
- The "Indications for Use" statement explicitly confirms that the indications are the same as the previously cleared predicate device (K973782).
- The overall conclusion is that "the data provided regarding the modifications to the predicate device support the safety and effectiveness" for the stated indications.
In essence, the "proof" the device meets acceptance criteria is based on laboratory biocompatibility tests that showed no adverse biological reactions, combined with a justification that its components and intended use are similar to or modifications of previously cleared safe and effective devices.
§ 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).