(76 days)
Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.
Beautifil Flow Plus is a light-curing dental filling material having low viscosity.
This document is a 510(k) premarket notification for a dental filling material, Beautifil Flow Plus. It is a letter from the FDA confirming substantial equivalence to a predicate device. This type of document, particularly for a dental filling material, is unlikely to contain information about acceptance criteria and a study proving device performance in the way requested for software or AI-based medical devices.
Medical devices like dental fillings are typically evaluated based on material properties, biocompatibility, and clinical performance through different types of studies (e.g., in vitro, in vivo, clinical trials for safety and effectiveness). The acceptance criteria would relate to these aspects rather than metrics like sensitivity/specificity for diagnostic devices.
Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sample size for test sets, expert ground truth, MRMC studies) will not be present in this FDA letter for a dental filling material.
Let's break down what can be inferred or stated based on the provided text, and what cannot.
1. A table of acceptance criteria and the reported device performance
- Cannot be provided from this document. This document is an FDA clearance letter confirming substantial equivalence, not a detailed study report. It does not contain a table of acceptance criteria or performance metrics for diagnostic accuracy. For a dental filling material, acceptance criteria would typically involve physical properties (e.g., compressive strength, wear resistance), chemical properties (e.g., leachables), and biocompatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided from this document. This information pertains to a performance study for diagnostic AI/software, which is not relevant to this type of device and document.
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)
- Cannot be provided from this document. This is not applicable to a dental filling material.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided from this document. This is not applicable to a dental filling material.
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
- Cannot be provided from this document. This type of study is for diagnostic devices with AI assistance, not for a dental filling material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided from this document. This is not applicable to a dental filling material.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided from this document. This is not applicable to a dental filling material.
8. The sample size for the training set
- Cannot be provided from this document. This information is for AI/machine learning models, not for a dental filling material.
9. How the ground truth for the training set was established
- Cannot be provided from this document. This information is for AI/machine learning models, not for a dental filling material.
Summary based on the document:
The provided document is an FDA 510(k) clearance letter for a dental filling device, "Beautifil Flow Plus." The letter states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices."
This document confirms regulatory clearance based on substantial equivalence, but it does not contain the detailed technical study information (acceptance criteria, performance metrics, sample sizes for diagnostic accuracy studies, expert ground truth, etc.) that would typically be part of a submission for an AI-powered diagnostic device. The evaluation for a dental filling material would focus on material properties, biocompatibility, and clinical safety and effectiveness data (often comparing to a predicate device), which are not detailed in this specific FDA clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David P. Morais Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078-4059
AUG 2 3 2010
Re: K101603
Trade/Device Name: Beautifil Flow Plus Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Regulatory Class: II Product Code: EBF Dated: June 7, 2010 Received: June 8, 2010
Dear Mr. Morais:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. David P. Morais
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known):
Device Name: Beautifil Flow Plus
Indications For Use:
Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
. . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: Shofu Dental Corporation BEAUTIFIL FLOW PLUS 510(k) Premarket Notification
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.