AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL by DENTSPLY INTL.

AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.

AQUASIL™ RIGID Fast Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV Fast Set Impression Material in a dual phase impression Technique, capturing one or two adjacent preparations. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.

Device Description

AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is a two-part (base/catalyst) hydrophilic vinylpolysiloxane (VPS), crown and bridge impression material used to record the details of hard and soft surfaces of the oral cavity.

AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. These elastomeric impression materials have excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.

AQUASIL™ RIGID Regular Set and Fast Set IMPRESSION MATERIALs improve both wetting on the tooth surface and model detail reproduction.

AI/ML Overview

The provided text describes a 510(k) summary for a dental impression material (AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL). This document focuses on demonstrating substantial equivalence to a predicate device, primarily through biocompatibility testing and a brief mention of "performance data". However, it does not contain the specific information required to answer the questions about acceptance criteria, device performance,study details, and AI-related metrics.

Here's a breakdown of what can be inferred or what is explicitly missing:

Missing Information:

The document is a pre-market notification (510k) for a medical device that is a material, not an AI software or a device that has "performance" in the way an AI algorithm would have sensitivity, specificity, etc. Therefore, most of the requested information (items 1-9) is not applicable or cannot be extracted from this type of regulatory submission. The "performance data" mentioned is likely related to physical properties of the impression material, not a clinical study involving human readers or comparative effectiveness with an AI.

Specific Points Addressing the Request (or explaining why it's not present):

Table of acceptance criteria and reported device performance: Not provided. The document focuses on biocompatibility and general characteristics like hydrophilicity, dimensional accuracy, tear strength, and resistance to permanent deformation, but doesn't quantify "acceptance criteria" in a table format with specific performance metrics for these properties.
Sample size for the test set and data provenance: No specific test set for performance (as would be measured for an AI device) is mentioned. The biocompatibility tests involved "catalyst and base pastes and the mixed product." Data provenance (country of origin, retrospective/prospective) is not applicable or stated for material testing.
Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for an AI device is not relevant here. Biocompatibility tests are laboratory-based.
Adjudication method for the test set: Not applicable. Material testing rather than image interpretation.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a material, not an AI or image-based diagnostic device.
Standalone (algorithm only) performance: Not applicable. This is a physical impression material.
Type of ground truth used: Not applicable. Biocompatibility results are laboratory measurements (cytotoxicity levels, mutagenicity, irritation scores), not ground truth in the context of an AI study.
Sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
How the ground truth for the training set was established: Not applicable.

What is present in relation to "performance" and "criteria" (albeit not in the requested format):

Biocompatibility Testing (for the predicate device K943574):
- Evaluated for: Cytotoxicity (base pastes gave moderate; catalyst pastes non-cytotoxic; mixed product lower value than Reprosil), Dermal Toxicity (mixed product: non-toxic), Irritation (mixed product: non-irritant), Mutagenicity (mixed product: non-mutagenic via Ames test).
Performance Characteristics (for the new device AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL):
- Hydrophilic properties
- Dimensional accuracy
- High tear strength
- Resistance to permanent deformation
- Improved wetting on the tooth surface
- Improved model detail reproduction

Conclusion:

The provided 510(k) summary is for a dental impression material and does not detail the kind of acceptance criteria and studies relevant to an AI/software device or a comparative effectiveness study involving human readers. The "performance data" mentioned refers to physical and biological properties of the material itself, not diagnostic accuracy or expert interpretation.

Summary

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K970Ø433

510(k) SUMMARY

Page 1 of 2

DENTSPLY

NAME & ADDRESS :

MAR 2 7 1997

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn February 3, 1997 DATE PREPARED: CONTACT :

AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL TRADE NAME :

Impression Material CLASSIFICATION NAME:

AquaSil™ Smart Wetting Impression Material K943574 PREDICATE DEVICE:

DEVICE DESCRIPTION: AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is a two-part (base/catalyst) hydrophilic vinylpolysiloxane (VPS), crown and bridge impression material used to record the details of hard and soft surfaces of the oral cavity.

AQUASIL™ RIGID SMART WETTING Regular Set and Fast Set IMPRESSION MATERIALs improve both wetting on the tooth surface and model detail reproduction.

INTENDED USE: AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.

TECHNOLOGICAL CHARACTERISTICS: All of the components of AQUASIL® RIGID SMART WETTING IMPRESSION MATERIAL have been used in DENTSPLY predicate The one component not found in the predicate device (K943574) devices. has been used in DENTSPLY's legally marketed Reprosil® Impression Material (K781151A) .

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510(k) SUMMARY (cont'd.)

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TRADE NAME: AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL

Due to the similarity of the formulation of AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL to the AquaSil™ Smart Wetting Heavy Body Impression Material, we believe that additional biocompatibility testing of the new impression material is unnecessary.

The predicate device, AquaSil® Smart Wetting Impression Material, was evaluated in K943574, as outlined below:

The catalyst and base pastes and the mixed product were evaluated for cytotoxicity. The mixed product was evaluated for dermal toxicity, for irritation, and for mutagenicity.

The base pastes give a moderate cytotoxicity and the catalyst pastes were non-cytotoxic. When mixed, the cytotoxicity persisted, but was recorded as a lower value than the value for Reprosil Impression Material.

The mixed product was tested by the Ames Mutagenicity Test, Acute Dermal Toxicity Test, and the Hamster Cheek Pouch Irritation Study. The final product is non-mutagenic, non-toxic, and a non-irritant.

As crown and bridge impression materials, AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL and the predicate device (K943574) are in the mouth for, at most, ten minutes.

We believe that the prior use of the components in predicate medical devices, the results of the final product testing of the predicate device, the limited exposure time in the mouth, and the performance data outlined above support the safety and effectiveness of AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL for the intended use.

000019

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).