The devices are intended to measurement the human body temperature, and specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.

Device Description

The device is an electronic thermometer with a hinged probe and an LCD display. The device was designed to measure human body predictive temperature (fast mode) around four seconds with predictive algorithm technology. If the predictive temperature cannot be measured, the device will take actual temperature (regular mode) automatically.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital Clinical Thermometer Model KD-193. It's important to note that the provided text is a 510(k) summary for a digital clinical thermometer, not an AI/ML device. Therefore, many of the typical acceptance criteria and study details associated with AI/ML devices (like sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable or not present in this type of submission.

The "study" here refers to demonstrating compliance with established performance standards for medical devices, rather than a clinical trial validating an AI algorithm's diagnostic accuracy.

Acceptance Criteria and Device Performance

The provided 510(k) summary for the Digital Clinical Thermometer Model KD-193 focuses on compliance with established medical device standards. Explicit numerical acceptance criteria are not detailed in the given text for various performance metrics, but rather the device's ability to meet specific standards is the "acceptance criteria." The reported device performance is its compliance with these standards.

Acceptance Criteria (Standards Compliance)	Reported Device Performance
EN 60601-1-2 (1996) (EMC)	Complies
EN 55011 (1991) (EMC)	Complies
IEC 801-2 (1991) (ESD)	Complies
IEC 801-3 (1984) (EMF Immunity)	Complies
ASTM E1112-00 (Electronic Thermometer Standard)	Complies

Note: The ASTM E1112-00 standard for electronic thermometers includes specific accuracy requirements (e.g., within ±0.1°C or ±0.2°F for certain ranges), but these specific numerical criteria are not explicitly stated in the provided text, only the compliance with the standard is mentioned.

Study Details (as inferable from a non-AI/ML device submission)

Sample size used for the test set and the data provenance:
- Not applicable / Not explicitly stated for this type of device. For a basic clinical thermometer, "testing" involves verification that the device meets the physical and electrical requirements of the cited standards. This typically involves calibration against known standards and environmental testing, not a "test set" in the context of an AI algorithm. The text doesn't provide details on the number of units tested or the origin of any "data" beyond its design and manufacturing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of AI refers to accurate labels for data. For a thermometer, the "ground truth" is established by highly accurate reference thermometers used in calibration laboratories, and the expertise lies in metrology and engineering, not medical interpretation by human experts in a clinical setting for a test set.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of medical images or data for AI model training/testing. This is not relevant to the performance testing of a physical electronic thermometer.
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:
- Not applicable. MRMC studies are specific to evaluating the impact of AI on human readers (e.g., radiologists, pathologists). This device is a standalone measurement tool, not an AI diagnostic aid for human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, but not in the AI sense. The device itself is standalone in its function as a temperature measurement device. Its "predictive algorithm" is an internal function to estimate temperature quickly. The performance data is the standalone performance of the device without human interpretation of its output beyond reading the LCD display. However, this is not "standalone AI algorithm performance" in the context of diagnostic AI.
The type of ground truth used:
- Reference standards/Metrology. For a thermometer, the "ground truth" for its accuracy is established by comparing its readings to highly accurate, calibrated reference thermometers or temperature standards in a controlled laboratory environment.
The sample size for the training set:
- Not applicable / Not explicitly stated. For the "predictive algorithm" mentioned, there would have been some form of data collection (e.g., simultaneous readings of the probe and a reference thermometer over time) to develop and "train" the algorithm to predict final temperature rapidly. However, the document does not provide details on the sample size of such data.
How the ground truth for the training set was established:
- Not explicitly stated, but inferred to be reference temperature readings. For the predictive algorithm, "ground truth" would be the actual stable body temperature measured over a longer period by a highly accurate reference thermometer, against which the rapid, predictive readings of the device would be compared and the algorithm would be tuned. This would be established through controlled human or animal subject studies, or simulations, where stable temperatures are accurately measured via reference instruments.

Summary

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510(k) Summary

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Daniel Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386

Date Prepared: June 5, 2002

Name of Device and Name/Address of Sponsor

Digital Clinical Thermometer Model KD-193

K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person : Daniel Tseng

Common or Usual Name	Digital Thermometer
Classification Name	Class II §880.2910 Clinical ElectronicThermometer
Predicate Device	I. K-jump Health Co., Ltd. K-jumpDigital Clinical ThermometerII. Advanced Bioresearch Assoc.SureTemp® Electronic Thermometer

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Intended Use/Indications for Use

The devices are intended to measurement the human body temperature, and specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.

Technology Characteristics

Performance Data

The Digital Clinical Thermometer model KD-193 complies with EN 60601-1-2 (1996); EN 55011 (1991); IEC 801-2(1991); IEC 801-3(1984) and the ASTM E1112-00 Electronic Thermometer for Intermittent Determination of Patient Temperature standard.

Substantial Equivalence

The device is substantially equivalent to K-jump's Digital Clinical Thermometer (K903590) and Advanced Bioresearch Assoc.'s SureTemp® Electronic Thermometer (K943695). The devices share the same intended use an indication for use and are technologically identical.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.

JUL 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K-Jump Health Company Limited C/O Mr. Jonathan S. Kahan Hogan & Harton L.L.P. 555 Thirteen Street, N.W. Washington, D. C. 20004-1109

Re: K021851

Trade/Device Name: Digital Clinical Thermometer Model KD-193 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 5, 2002 Received: June 5, 2002

Dear Mr. Kahan:

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.

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.

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Page 2 – Mr. Kahan

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timo 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 Form

510(k) Number (if Known):

Device Name: Digital Clinical Thermometer Model KD-193

Indication for Use:

The Digital Clinical Thermometer Model KD-193 is intended to measure the human body temperature and is specifically indicated to operate in either predictive mode or regular mode orally, rectally or under the arm.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use________ (Per 21 C.F.R. 801.109)

Patura Crescent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_ KO26851

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.