(377 days)
This" LED Curing Light LD-M1" is for the polymerization of light cure materials.
Not Found
This is a 510(k) clearance letter from the FDA for a dental curing light, the "LED Curing Light LD-M1". This type of document typically determines substantial equivalence to a predicate device based on performance testing to recognized standards, rather than providing a detailed study description with specific acceptance criteria and detailed device performance reports like those found for AI/ML devices or diagnostic tools.
Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) is not available within this document.
The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indications for use provided. The "Indications for Use" section (page 2) simply states: "This "LED Curing Light LD-M1" is for the polymerization of light cure materials."
To fulfill the request, if this were a clinical study report for a diagnostic or AI/ML device, the following would typically be provided:
- Acceptance Criteria Table and Reported Device Performance: This would detail metrics like sensitivity, specificity, accuracy, precision, etc., for the device against an established benchmark, along with the predefined thresholds for acceptance.
- Sample Size and Data Provenance: Information on the number of cases, their origin (e.g., US, Europe), and whether the data was collected specifically for the study (prospective) or from existing archives (retrospective).
- Number and Qualifications of Experts: Details about the radiologists, pathologists, or other specialists who reviewed the cases to establish ground truth, including their experience levels.
- Adjudication Method: How disagreements among experts were resolved (e.g., a third expert reviewed discordant cases, or a consensus meeting was held).
- MRMC Study: If applicable, an analysis comparing human reader performance with and without the AI device, quantified by an effect size (e.g., AUC improvement, sensitivity increase).
- Standalone Performance: The performance of the algorithm itself, independent of human interaction.
- Type of Ground Truth: The gold standard used (e.g., confirmed pathology, long-term patient outcomes, expert consensus).
- Training Set Sample Size: The number of data points or cases used to train the algorithm.
- Training Set Ground Truth Establishment: How the ground truth for the training data was determined.
Since this document is a 510(k) clearance for a physical device (a dental curing light), these clinical study details are not relevant or provided. The clearance is based on demonstrating that the device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing rather than complex clinical studies involving human readers or AI algorithms.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7,2014
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: K133040
Trade/Device Name: LED Curing Light LD-M1 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: July 14, 2014 Received: July 14, 2014
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. Isting 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. Wang
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.
Susan Runno DDS, MA
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): Device Name: LED Curing Light LD-M1 Indications For Use:
This" LED Curing Light LD-M1" is for the polymerization of light cure materials.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use____________________ (21CFR 801 Subpart C)
(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.