The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.

Device Description

The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, nonpredictive clinical electronic thermometer designed to measure and assess the temperature of humans of all age ranges using an infrared detector to detect heat emission from the forehead. The measured temperature correlates to axillary temperature, and is displayed on a built-in LCD display. Calendar/clock functions are provided, and a memory function stores up to 10 temperature readings. The temperature reading range is 34 °C – 42.2 °C (92.3 F to 108.0 F), and the time of measurement is approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings. The unit operates in an ambient temperature range of 16 C – 35 C (61 F to 95 F). The FT101 Forehead Thermometer is entirely self-contained within one housing, and is battery-powered. The device is compact in size and weight, easy to use, portable and may be used in a variety of home or clinical settings.

AI/ML Overview

The provided documentation is a 510(k) summary for the FT101 Forehead Thermometer, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel efficacy claims. As such, information regarding comprehensive clinical trials with specific acceptance criteria, sample sizes for training/test sets, expert qualifications, and detailed statistical analysis often found in studies for new drugs or high-risk devices is generally not included in this format.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or a detailed breakdown of reported device performance as one might expect from a formal efficacy study. However, it states compliance with voluntary standards, which implicitly define performance criteria.

Implied Acceptance Criteria (from standard compliance):
- Accuracy: Conformance with ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). This standard likely specifies accuracy limits (e.g., maximum permissible error at certain temperature ranges).
- Safety: Conformance with EN 60601-1/A13 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and EN 60601-1-2 (Electromagnetic compatibility - Requirements and tests).
- Specific Temperature Range: The device claims a reading range of 34 °C – 42.2 °C (92.3 F to 108.0 F).
- Measurement Time: Approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings.
- Ambient Temperature Range: Operates in 16 C – 35 C (61 F to 95 F).
Reported Device Performance: The document only generally states that "safety and efficacy performance of the device has been established clinically and non-clinically through comparative testing to market-cleared devices in accordance with ASTM E1965-98 and prEN 12470-5 voluntary standards, and without raising new safety or effectiveness issues." No specific accuracy figures (e.g., mean difference, standard deviation of error) or sensitivity/specificity values are provided.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for clinical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "comparative testing to market-cleared devices." For a 510(k), often the clinical data requirement is less stringent than for a PMA, sometimes relying on equivalence to a predicate device's performance rather than large-scale de novo efficacy trials.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document. Given that the device measures a physical parameter (temperature), the "ground truth" would likely be established by a reference thermometer standard (e.g., a calibrated contact thermometer) rather than expert consensus on interpretation.

4. Adjudication Method

The document does not mention any adjudication method, which is typically relevant for studies involving subjective interpretation (e.g., reading medical images) rather than objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. This type of study is usually conducted for diagnostic imaging devices where human readers interpret outputs, often with AI assistance. The FT101 is a direct measurement device, not an interpretation aid.

6. Standalone Performance Study (Algorithm Only)

The FT101 is a standalone device in the sense that it performs the temperature measurement directly without human interpretation of an algorithm's output. The performance data refers to the device's ability to measure temperature, not an algorithm's ability to process data, so this question isn't directly applicable in the typical sense of AI/algorithm performance. Its "standalone performance" is implicitly covered by the "safety and efficacy performance" mentioned as being established through testing against standards.

7. Type of Ground Truth Used

The ground truth for temperature measurement would be established by:

Calibrated reference thermometers: This is the most common method for validating the accuracy of clinical thermometers, where the device's reading is compared against a highly accurate and calibrated reference.
Axillary temperature: The indication states the output "correlates to axillary temperature," suggesting that axillary temperature taken with a validated method was likely used as a comparative ground truth in some part of the "clinical" testing.

8. Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning algorithms. While the FT101 uses an infrared detector, it's not described as an AI-driven device requiring a training set in the typical sense. Therefore, no training set sample size is mentioned.

9. How the Ground Truth for the Training Set was Established

As there's no mention of a training set or an AI algorithm, this information is not applicable and not provided.

In summary: The provided 510(k) summary states that the FT101 Forehead Thermometer meets performance criteria by conforming to voluntary standards (EN 60601-1/A13, EN 60601-1-2, ASTM E1965-98, prEN 12470-5) through "comparative testing to market-cleared devices clinically and non-clinically." However, it does not provide detailed quantitative results, sample sizes for testing, or information about how ground truth was specifically quantified beyond compliance with these broad standards. This is typical for a 510(k) where the focus is on demonstrating substantial equivalence to a predicate device rather than novel efficacy studies.

Summary

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510(k) Summary FT101 Forehead Thermometer FT101 Infrared Digital Thermometer 510(k) Number K020433

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

1. APPLICANT'S INFORMATION: Stephen Li Vice President - Health Care Products IDT Technology Limited Block C, 9/F., Kaiser Estate, Phase 1 41 Man Yue Street, Hunghom Hong Kong, CHINA (852) 2764 7873 Tel: Fax: (852) 2765 6620 idthk@idthk.com Email: http://www.idthk.com Web Site: Medical Establishment Registration No .: 9680516
1. SUBMITTER'S INFORMATION: James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 391117 Solon, OH 44139 440.546.4936 PH/FX: 412-596.2578 Mobile: E-mail: coastalcg@earthlink.net
1. Date:

February 6, 2002

1. DEVICE INFORMATION DEVICE NAME: Clinical Electronic Thermometer Classification Panel: General Hospital 882.2910 Clinical Electronic Thermometer Classification Number: Thermometer, Clinical, Electronic Product Nomenclature: Product Code(s): 80FLL Trade/Proprietary Name: FT101 Forehead Thermometer; FT101 Infrared Digital Thermometer Electronic Thermometer
  Common Name:
1. DEVICE CLASSIFICATION: Clinical Electronic Thermometers are Class II devices, and are reviewed by the General Hospital Division.
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6. PREDICATE DEVICE(s):

ThermoTek IR Forehead Thermometer Model 718F, K002712, currently in commercial distribution in the US.

7. DEVICE DESCRIPTION:

The temperature reading range is 34 °C – 42.2 °C (92.3 F to 108.0 F), and the time of measurement is approximately 2 seconds, with a recommended cycle time of at least 30 seconds between readings. The unit operates in an ambient temperature range of 16 C – 35 C (61 F to 95 F). The FT101 Forehead Thermometer is entirely self-contained within one housing, and is battery-powered. The device is compact in size and weight, easy to use, portable and may be used in a variety of home or clinical settings.

8. INDICATIONS FOR USE:

The FT101 Forehead Thermometer is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement of the outer surface temperature of the human body of people of all ages.

9. TECHNOLOGICAL CHARACTERISTICS:

The manufacturer believes that the technological characteristics of the FT101 is substantially similar to those of the predicate device.

10. PERFORMANCE DATA:

The FT101 conforms with the following voluntary standards: EN 60601-1/A13, EN 60601-1-2. Additionally, safety and efficacy performance of the device has been established clinically and non-clinically through comparative testing to market-cleared devices in accordance with ASTM E1965-98 and prEN 12470-5 voluntary standards, and without raising new safety or effectiveness issues.

11. STATEMENT OF SUBSTANTIAL EQUIVALENCE:

Based upon the safety and performance testing and compliance with voluntary standards, the manufacturer believes that the FT101 Forehead Thermometer is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 11 2002

IDT Technology Limited C/O Mr. James J. Rogers General Manager Coastal Consulting Group, Limited P.O. Box 391117 Solon. Ohio 44139

Re: K020433

Trade/Device Name: FT 101 Forehead Thermometer, FT 101 Infrared Digital Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 11, 2002 Received: May 14, 2002

Dear Mr. Rogers:

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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,
Ky Allatrist

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K020433

FT101 Forehead Thermometer Device Name: FT101 Infrared Digital Thermometer

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109

OR and the model's response is:{

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number _

THE END

Regulation Number and Section

§ 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.