(38 days)
The device is indicated for use by dental technicians in the construction of custom porcelain (ceramic) and porcelain (fused to metal) dental restorations for anterior and posterior locations.
For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses.
The device is comprised of dental porcelain powder that is used in the form of powder or blanks as a part of dental laboratory processes that are used to fabricate porcelain (ceramic) and porcelain (fused-to-metal) dental devices that are custom fitted to conform precisely to patients' models.
The provided text is a 510(k) summary for a dental porcelain powder, not a medical device that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy, especially as demonstrated through a study with a test set, ground truth from experts, or MRMC studies.
The document discusses substantial equivalence based on the device's function and intended use being similar to predicate devices already on the market. It doesn't present a study designed to prove specific performance metrics against acceptance criteria that involve diagnostic accuracy or similar outcomes.
Therefore, most of the requested information (points 1-9) cannot be extracted from this document because it describes a different type of regulatory submission and device.
Here's an analysis of what can be inferred or stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" for a 510(k) submission for this type of device are primarily related to demonstrating substantial equivalence to predicate devices, meaning it functions similarly and has the same intended use without raising new safety concerns.
- Reported Device Performance: The document states, "The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations." This is a qualitative statement of performance similarity rather than quantitative data.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. There is no mention of a test set, clinical data, or data provenance in the context of a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No ground truth establishment for a test set is discussed.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method is mentioned as there is no test set for performance evaluation.
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 is not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a material (porcelain powder), not an algorithm or software.
7. The Type of Ground Truth Used:
- Not applicable in the context of a diagnostic performance study. The "ground truth" for this submission is implicitly established by the long-standing safe and effective use of similar predicate devices in the dental field.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a training set for an algorithm or model.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary: The provided 510(k) summary for "Prismatik™ Ceramic" focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a performance study against specific, quantifiable acceptance criteria typical for diagnostic or AI-powered devices. The "study" mentioned is the general understanding and use of similar materials in the dental field, which is deemed sufficient to assure its safety and effectiveness.
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MAR 3 - 2005
510(k) Summary
Submitter: Glidewell Laboratories 4141 MacArthur Blvd. Newport Beach, CA 92660
Contact Person Keith D. Allred 949-440-2683 949-440-2787 (fax)
Date of Application: January 11, 2005
Device Name:
- · Trade Name Prismatik™ Ceramic
- · Common Name Porcelain powder for clinical use
- · Classification II
- · Product Code EIH
Description: The device is comprised of dental porcelain powder that is used in the form of powder or blanks as a part of dental laboratory processes that are used to fabricate porcelain (ceramic) and porcelain (fused-to-metal) dental devices that are custom fitted to conform precisely to patients' models.
Intended Use: The device is indicated for use by dental technicians in the construction of custom porcelain (ceramic) and porcelain (fused to metal) dental restorations for anterior and posterior locations.
Substantial Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: Avante Micro Crystal® and OPC® Porcelain (Jeneric/Pentron) and Cerabien ZR Porcelain (Noritake).
Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations.
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Public Health Service
Image /page/1/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The text is in all capital letters and appears to be in a sans-serif font.
MAR 3 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith D. Allred Glidewell Laboratories 4141 MacArthur Boulevard Newport Beach, California 92660
Re: K050144
Trade/Device Name: Prismatik™ Ceramic Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 11, 2005 Received: January 24, 2005
Dear Mr. Allred:
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 - Mr. Allred
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 nfour that I 22 x y Federal statutes and regulations administered by other Federal agencies. ox the Fet of any I outh 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 and instille (s 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), n Jose contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mav 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/industry/support/index.html.
Sincerely vours.
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
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K05 0/44
Schedule B
Sample Device Label/Indications for Use Statement
- 510(k) Number (if known): ♪
- Device Name: Prismatik™ Ceramic ア
- Indications for Use: す
For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
Susan Runover
vision Sign-Off) . sion of Anesthesiology, General Hospital, rection Control, Dental Devices
Number: K850144
§ 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.