FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Aquasil® Ultra+ Smart Wetting® Impression Material is a quadrafunctional hydrophilic addition reaction silicone elastomeric dental impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.

AI/ML Overview

This document describes the Aquasil® Ultra+ Smart Wetting® Impression Material, a dental impression material. The submission focuses on demonstrating substantial equivalence to a predicate device after a modification to the surfactant used in the material.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Internal DENTSPLY Procedure Requirements/ISO Standards)	Reported Device Performance (Aquasil® Ultra+ Smart Wetting® Impression Material)
Wettability (Contact Angle)	Meets Internal DENTSPLY procedure requirements
Mechanical (Compressive Strength, Tear Strength)	Meets Internal DENTSPLY procedure requirements
Uncured Base Paste – Cytotoxicity Study Using the ISO Elution Method	Meets ISO Elution Method requirements
Uncured Catalyst Paste – Cytotoxicity Study Using the ISO Elution Method	Meets ISO Elution Method requirements
Cured Base/Catalyst – Cytotoxicity Study Using the ISO Agarose Overlay Method	Meets ISO Agarose Overlay Method requirements
ISO Oral Mucosal Irritation Study in Hamsters – Collar Method - 24 Hrs.	Meets ISO Oral Mucosal Irritation requirements
ISO Guinea Pig Maximization Sensitization Test	Meets ISO Guinea Pig Maximization Sensitization Test requirements
OECD 425 Acute Oral Toxicity Study in Rats, Limit Test	Meets OECD 425 Acute Oral Toxicity requirements
ISO 4823 Dentistry - Elastomeric Impression Materials	Meets the requirements of ISO 4823

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical bench tests and biocompatibility tests. The document states:

"The performance of the Aquasil® Ultra + Smart Wetting® Impression Material satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence."
"The results of the biocompatibility testing of Aquasil® Ultra + Smart Wetting® Impression Material are equivalent to the predicate device Aquasil® Ultra Smart Wetting® Impression Material 510(k) cleared under K113406."
"The test results of Aquasil Ultra + Smart Wetting® Impression Material LV Base and Catalyst paste, met the requirements of the three recommended biocompatibility tests; as per ISO10993-1:2009; Cytotoxicity, Sensitization (Delayed-type hypersensitivity), and Irritation or intracutaneous reactivity."
"Other tests, including Contact Angle and Tear Strength were performed and the results of these activities... support substantial equivalence."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each individual test. It mentions that "All required verification and validation activities, as identified through risk analysis were performed."
Data Provenance: The data provenance is primarily from bench testing and biocompatibility studies conducted by DENTSPLY International, Inc. This would typically be prospective testing performed in a controlled laboratory environment to evaluate the modified device. There is no mention of country of origin for the data beyond DENTSPLY's location in York, PA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The testing described is primarily physical property measurement and biocompatibility studies, which do not typically involve human expert interpretation of results to establish ground truth in the way medical imaging algorithms do. The "ground truth" here is objective measurement against established ISO standards and internal procedure requirements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically relevant for human-interpreted data, especially in clinical trials or image-based diagnostic studies. Since this submission is for a dental impression material and focuses on non-clinical performance and biocompatibility, an adjudication method for a test set is not applicable and therefore not described.

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

No MRMC comparative effectiveness study was done. This is a submission for a dental impression material, not an AI-powered diagnostic device, so this type of study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not an AI-powered device. Therefore, a standalone algorithm performance evaluation is not applicable. The tests are performed on the material itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical performance tests and biocompatibility studies is based on established international standards (ISO, OECD) and internal DENTSPLY procedure requirements. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set

This is not an AI/machine learning device that requires a training set. Therefore, sample size for a training set is not applicable.

9. How the Ground Truth for the Training Set was Established

As this is not an AI/machine learning device, there is no training set and therefore no ground truth established for a training set.

Summary

Regulation Number and Section

§ 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).