(53 days)
Imagine Reflex is a dental ceramic that can be used by dental technicians to fabricate porcelain-fused-to-metal restorations. It is suitable for veneering dental alloys with a coefficient of thermal expansion [CTE(25 -500°C): 13.8 – 15.1 x 10*K¹] and a solidus temperature that has to exceed 1000°C (1830°F) as well as electroformed galvanogold.
Imagine Reflex can be used for veneering inlays, partial crowns, single crowns, and bridges.
Not Found
The provided text is a 510(k) summary for a dental ceramic product, Imagine® Reflex®. It primarily focuses on regulatory information, specifically demonstrating substantial equivalence to a predicate device. This type of submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be relevant to software or AI-based medical devices.
Therefore, based on the provided text, I cannot extract the information required to populate the requested table and answer the specific questions about acceptance criteria and study details. The document relates to a material science product (dental porcelain), not a diagnostic device or a device with an AI component.
Here's a breakdown of why the information is not present in the provided text:
- No "device performance" in the AI/Software sense: Dental ceramic performance is typically evaluated by material properties (e.g., strength, thermal expansion, compatibility with alloys), not by diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI/software devices.
- No "acceptance criteria" related to diagnostic accuracy: The criteria for a dental ceramic would involve material standards and biocompatibility, not statistical thresholds for diagnostic performance.
- No "test set," "training set," "ground truth," or "experts" for diagnostic evaluation: These concepts are central to validating AI and diagnostic devices. For a dental ceramic, the "ground truth" might be defined by chemical composition or mechanical testing results, not by expert consensus on images.
- No "MRMC study" or "standalone performance": These are specific to evaluating how well an algorithm (with or without human assistance) performs a diagnostic task.
Conclusion: The provided regulatory document for K031326, Imagine® Reflex®, is for a dental material and does not contain the type of study information (acceptance criteria, performance metrics, sample sizes, expert ground truth, or MRMC studies) typically found in submissions for AI or software-driven medical devices. Therefore, I cannot generate the requested table or answer the specific questions based on this document.
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JUN 1 7 2003
Premarket Notification 510(k)
lmagine Reflex
5. 510 (k) Summary
| Submitter of 510(k): | Wieland Dental + Technik GmbH & Co. KG |
|---|---|
| Schwenninger Str. 13 | |
| D-75179 Pforzheim | |
| Germany | |
| Phone: +49-7231-3705-0 |
Contact person: Phone: Fax: e-mail:
Dr. Gerhard Polzer +49—7231—3705—219 +49-7231-357959 gerhard.polzer@wieland-dental.de
2003-04-02 Date of Summary:
Trade name:
IMAGINE® Reflex
Classification name: Product code: EIH C.D.R section: Classification:
Porcelain powder for clinical use 872.6660 Class II
Legally marketed equivalent device: Duceram-Metal-Ceramic Dental Porcelain System 510(k) number: K871808
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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features an abstract image of an eagle in the center. The eagle is made up of three curved lines that represent the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2003
Gerhard Polzer, Ph.D. Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
Re: K031326
Trade/Device Name: Imagine® Reflex® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: April 08, 2003 Received: April 25, 2003
Dear Dr. Polzer:
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.
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Page 2 - Dr. Gerhard Polzer
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) 594-4613. 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" (21CFR Part 807.97) you may obtain. 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,
Suses Quares
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
K031326
IMAGINE® Reflex®
Device Name:_
Indications For Use:
Imagine Reflex is a dental ceramic that can be used by dental technicians to fabricate porcelain-fused-to-metal restorations. It is suitable for veneering dental alloys with a coefficient of thermal expansion [CTE(25 -500°C): 13.8 – 15.1 x 10*K¹] and a solidus temperature that has to exceed 1000°C (1830°F) as well as electroformed galvanogold.
Imagine Reflex can be used for veneering inlays, partial crowns, single crowns, and bridges.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X | |
|---|---|---|
| OR | Over-The-Counter Use ______ | |
| (Division Sign-Off) | Ken Muly fa MSR | (Optional Format 1-2-96) |
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K031326 |
|---|---|
| ---------------- | --------- |
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.