(21 days)
The FORA IR22 Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal. The device is indicated for use by people of all ages. It is also available to detect object's surface temperature including human skin.
The FORA IR22 Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal.
The provided document is an FDA 510(k) clearance letter for the FORA IR22 Ear Thermometer. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would be found in the 510(k) submission itself or the supporting technical documentation.
Therefore, I cannot extract the information required to populate all sections of your request. The FDA clearance letter only indicates that performance data was submitted and found acceptable for substantial equivalence, but it doesn't present the data itself.
Based on the provided document, here is what can be inferred or explicitly stated:
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A table of acceptance criteria and the reported device performance:
- N/A. This information is not present in the FDA clearance letter. Performance data and acceptance criteria would be detailed in the 510(k) submission document, which is not provided here.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- N/A. This information is not present in the FDA clearance letter.
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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):
- N/A. This information is not present in the FDA clearance letter.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This information is not present in the FDA clearance letter.
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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:
- N/A. This device is an ear thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. A thermometer operates in a standalone manner, providing a direct measurement. Its performance is evaluated on its accuracy and precision against a reference standard. The FDA clearance implies that such standalone performance (i.e., the device itself providing accurate temperature readings) was demonstrated. Specific metrics are not available in this letter.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Clinical reference thermometers/standards. For a clinical thermometer, the ground truth would typically be established by highly accurate, calibrated reference thermometers or other established temperature measurement methods in a clinical setting.
- N/A (specific details). The exact type of reference instrument or gold standard used is not detailed in this clearance letter.
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The sample size for the training set:
- N/A. Thermometers typically do not use "training sets" in the machine learning sense. Their accuracy is based on physical principles and calibration, not learned from data in the same way an AI algorithm would be. Performance is verified through clinical validation studies.
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How the ground truth for the training set was established:
- N/A. (See point 8).
Summary of what the document does tell us about the device:
- Device Name: FORA IR22 Ear Thermometer
- Regulation Number: 21 CFR 880.2910
- Regulation Name: Clinical Electronic Thermometer
- Regulatory Class: II
- Product Code: FLL
- Indications for Use:
- Electronic thermometer using an infrared sensor to detect human body temperature from the ear canal.
- Indicated for use by people of all ages.
- Available to detect object's surface temperature including human skin.
- Usage: Over the Counter Use
- Clearance Date: February 8, 2009 (Received February 5, 2009)
- Basis for Clearance: Substantial Equivalence to a legally marketed predicate device. This means the FDA reviewed performance data (accuracy, precision, etc.) and found it to be comparable to known safe and effective thermometers on the market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human services, with three overlapping figures or shapes.
Public Health Service
FEB & & 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yuhua Chen Assistant Manager TaiDoc Technology Corporation 6F, Number 127, Wugong 2nd Road Wugu Township Taipei County 248 CHINA (TAIWAN)
Re: K090294
Trade/Device Name: FORA IR22 Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 3, 2009 Received: February 5, 2009
Dear Mr. Chen:
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. Chen
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony V, matter for
Ginette Y. Michaud. M.D Acting 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: K090294
Device Name: FORA IR22 Ear Thermometer
Indications for Use:
The FORA IR22 Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal. The device is indicated for use by people of all ages. It is also available to detect object's surface temperature including human skin.
AND/OR Prescription Use _ (21 CFR Part 801 Subpart D)
Over the Counter Use X (21 CFR Part 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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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _KO90294
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.