(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.
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510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171845-7511 P. J. Lehn Telefax (7 7) 849-4343
P. Jeffery Lehn CONTACT:
May 2, 2002 DATE PREPARED:
TRADE NAME: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
Impression Material (872.3660) CLASSIFICATION NAME:
PREDICATE DEVICES: Aquasil XLV™ Smart Wetting Impression Material K973782
DEVICE DESCRIPTION: 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.
AQUASIL ULTRA XLV SMART WETTING IMPRESSION INTENDED USE: MATERIAL is 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.
TECHNOLOGICAL CHARACTERISTICS: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL represents a modification to Aquasil XLV Smart Wetting Impression Material (K943754).
All of the components have been used in legally marketed devices or were found to be safe for use. Uncured AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL was evaluated and passed biocompatibility testing for cytotoxicity. Cured AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL was evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, irritation and sensitization.
We believe that the data provided regarding the modifications to the predicate device support the safety and effectiveness of AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL for the indicated uses.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 8 2002
Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405
Re: K021410
Trade/Device Name: Aquasil Ultra XLV Smart Wetting Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 02, 2002 Received: May 03, 2002
Dear Mr. Lehn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 -- Mr. P. Jeffery Lehn
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patrice Cucent/fx
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
102 1410
Device Name: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
Indications for Use:
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.
These are the same Indications for Use as previously cleared for the Aquasil XL VTM Smart Wetting Impression Material (K973782).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Runnes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .
(Per 21 CFR 801.109)
MODIFICATION TO K973782
§ 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).