(73 days)
Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.
Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.
This document is a 510(k) premarket notification for a dental impression material, which typically involves demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with acceptance criteria and a test set and experts in the way machine learning algorithms are evaluated. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not applicable or not provided in the context of this type of regulatory submission.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" or provide "reported device performance" in the quantitative manner typically associated with clinical trials for new medical devices or software. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on the same intended use and basic technological characteristics of a dental impression material.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a dental impression material, not a study involving a test set of data in the context of a machine learning or diagnostic device study. The "test set" in this context would implicitly be the physical testing of the material's properties (e.g., set time, accuracy, tear strength), which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of experts establishing a ground truth for a test set in the provided summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no "test set" in the context of human interpretation.
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
Not applicable. This device is a dental impression material, not an AI-assisted diagnostic tool or system that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a dental impression material would likely refer to its physical and chemical properties meeting established standards for accuracy, stability, etc., which are usually validated through bench testing rather than clinical "ground truth" as in diagnostic studies. This summary does not provide details on such testing.
8. The sample size for the training set
Not applicable. The concept of a "training set" is not relevant for a physical dental impression material.
9. How the ground truth for the training set was established
Not applicable. The concept of a "training set" and its "ground truth" is not relevant for a physical dental impression material.
Summary of Device and Regulatory Context (Based on provided text):
- Device Name: Precision VPS Impression Material
- Applicant: Discus Dental, Inc.
- Application Type: 510(k) Premarket Notification
- Date of Summary: January 8, 2004
- Intended Use: For use with all crowns, bridges, occlusal, and dental implant impression procedures to reproduce the structure of a patient's teeth and gums.
- Device Description: An addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three viscosities.
- Regulatory Classification: Class II, Product Code ELW, Regulation Number 872.3660 (Impression Material)
- Basis for Substantial Equivalence: Precision VPS Impression Material is claimed to be substantially equivalent to:
The FDA's letter (dated March 25, 2004) confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use, allowing it to be marketed. This determination implies that the device has met the necessary regulatory requirements for substantial equivalence, which for this type of device typically involves demonstrating similar technological characteristics and performance (e.g., mechanical properties, biocompatibility) to the predicate devices, rather than a clinical study with primary endpoints and statistical analysis of a test set.
{0}------------------------------------------------
K0400053
Summary of Safety and Effectiveness B.
Precision VPS Impression Material
- Date of Summary: 1.
- Date of Summary 2. January 8, 2004 Preparation:
- Discus Dental, Inc. 3. Submitting Firm:
- Steven L. Ziemba, M.S. Contact Person 4. Vice-President, Regulatory Affairs Discus Dental, Inc. 8550 Higuera Street Culver City, CA 90232 310.845.8345 310.845.1537 - fax
- Name of Medical Device 5. Precision VPS Impression Material Proprietary Name: Dental Impression Material Common/Usual Name: Classification Name: Impression Material
- Description of Medical Device 6.
Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.
-
- Intended Use
Frecision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.
- Intended Use
-
Substantial Equivalence Determination 8.
Discus Dental, Inc. believes that the Precision VPS Impression material is substantially equivalent to the following commercially marketed impression materials:
Page 2 of 17
CONFIDENTIAL
{1}------------------------------------------------
Predicate Device Aquasil Ultra Smart Wetting Impression Material
Company Dentsply, Intl. 210(k) No K021416
P2 Polyether
Heraeus Kulzer GmbH
END OF SUMMARY OF SAFETY AND EFFECTIVENESS
Page 3 of 17
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized, curved shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2004
Mr. Steven L. Ziemba Vice-President, Regulatory Affairs Discus Dental, Incorporated 8550 Higuera Street Culver City California 90232
Re: K040053
Trade/Device Name: Precision VPS Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: January 9, 2004 Received: January 12, 2004
Dear Mr. Ziemba:
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.
{3}------------------------------------------------
Page 2 - Mr. Ziemba
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. 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), please contact the Office of Compliance at (301) 594-5613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chiu-Jung, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement E.
510(k) Number: K040053
Device Name: Precision VPS Impression material
Intended Use
Precision VPS Impression Material is intended for use with all crowns, bridges, Precision VFS impression Material is nechniques to reproduce the structure of a patient's teeth and gums.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription UsePor 21 CFR Section 801.109) | Over-The-Counter Useાર |
| WYA(Division Sian-Off,Division of Anesthesiology, General Hospital,Infection Control, Dental Devices510(k) Number: |
Page 6 of: 17
I viscus Dental, Inc.
CONFIDENTIAL
§ 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).