(207 days)
BlueLEX LED Curing Light LD-109 is for the polymerization of light cure materials.
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The provided document is a 510(k) premarket notification letter from the FDA for a dental curing light, the BlueLEX LED Curing Light LD-109. This type of document primarily confirms that a new device is substantially equivalent to existing legally marketed devices. It does not typically contain detailed information about specific acceptance criteria or studies proving device performance beyond confirming substantial equivalence for its stated indications for use.
Therefore, most of the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, standalone performance, ground truth types, and training set information) is not available in this document.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. Substantial equivalence to a predicate device is the overarching acceptance criterion for a 510(k) clearance.
- Reported Device Performance: The device is indicated for "polymerization of light cure materials." The letter indicates substantial equivalence, implying its performance is comparable to legally marketed predicate devices for this function. Specific performance metrics (e.g., light intensity, curing depth, curing time) are not detailed here.
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in a 510(k) clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in a 510(k) clearance letter.
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
- MRMC Study: No. This device is a dental curing light, not an AI-assisted diagnostic tool for human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as this is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The concept of "ground truth" as typically applied to diagnostic or AI studies is not relevant here for a dental curing light. The performance would likely be evaluated against physical standards or performance of predicate devices.
8. The sample size for the training set
- Not applicable/Not provided.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2015
Monitex Industrial Company, Ltd. Mr. Shu-Lung Wang President 6F, 70 Sec.1 Guang-Fu Road San-Chong District, New Taipei City Taiwan 241-58 REPUBLIC OF CHINA
Re: K150205
Trade/Device Name: BlueLEX LED Curing Light LD-109 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 29, 2015 Received: May 29, 2015
Dear Mr. Wang:
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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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 Know): K150205 Device Name: BlueLEX LED Curing Light LD-109 Indications For Use:
BlueLEX LED Curing Light LD-109 is for the polymerization of light cure materials.
Prescription Use
AND/OR
Over-The-Counter Use_ (21CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
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§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.