The Device measures the human body temperature from oral, axillary, and rectal. -The device is reusable and intended for clinical or home use on people of all ages.

Device Description

The Digital Thermometer is an electronic clinical thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans. Classic type and Flexible type have the same indication for use; however, Flexible type has a flexible tip.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study conducted for the Digital Thermometer:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ASTM E1112 ("Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature")	Conforms to ASTM E1112
IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	Conforms to IEC 60601-1
IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)	Conforms to IEC 60601-1-2

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

The provided document does not contain information about a test set sample size or data provenance for human clinical studies. It explicitly states: "Controlled human clinical studies ware not conducted using the Digital Thermometer Classic type and Flexible type and predicate devices."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no human clinical studies were conducted, there were no experts used to establish ground truth for a test set. The substantial equivalence was based on conformance to recognized standards.

4. Adjudication Method for the Test Set

As no human clinical studies were conducted, no adjudication method was used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device is a digital thermometer, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was done regarding human readers and AI assistance, and there is no effect size to report.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a digital thermometer, not an algorithm. Therefore, no standalone algorithm performance testing was done. The performance was assessed against recognized physical and operating standards.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established by conformance to internationally recognized standards for electronic thermometers (ASTM E1112, IEC 60601-1, IEC 60601-1-2). These standards define acceptable levels of accuracy, safety, and electromagnetic compatibility.

8. The Sample Size for the Training Set

This device is a digital thermometer, not a machine learning model. Therefore, there is no concept of a "training set" or "sample size for a training set" in this context.

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

As explained above, there is no training set for this device. The "ground truth" for the device's design and manufacturing was established by the requirements and specifications outlined in the referenced international standards. Developers ensure their device can meet these established, industry-accepted criteria through design, testing, and manufacturing processes, rather than through a machine learning training paradigm.

Summary

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510(k) Summary

(As required by 21 CFR 807.92)

NOV 21 2002

Premarket Notification Number: Applied for

1. Submitter's Identification:

Acute Ideas Co., Ltd. 3F, No.11, Lane 35, Jihu Road Neihu Dist., Taipei, Taiwan Tel: +886-2-87514868 Fax: +886-2-87515868 Contact: Mr. Albert Chen

Date Summary Prepared: Oct. 17, 2002

1. Name of the Device:
  Digital Thermometer Classic Type and Flexible Type

3. Predicate Device Information:

1. KEJUMP Digital Clinical Thermometer, K903590, K-Jump Health Co., Ltd.
1. Flexible Tip Digital Thermometer, K974195, K-Jump Health Co., Ltd.

4. Device Description:

5. Intended Use:

The device measures the human body temperature from oral, axillary, and rectal. The device is reusable and intended for clinical or home use on people of all ages.

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1. Comparison to Predicate Devices:
  The Digital Thermometer Classic type and Flexible type are substantial equivalence to K-Jump's Digital Clinical Thermometer and Flexible Tip Digital Thermometer.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

In terms of physical requirements and operating parameters, the Digital Thermometer Classic type and Flexible type conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature", as well as IEC 60601-1 and IEC 60601-1-2 requirements.

8. Discussion of Clinical Tests Performed:

Controlled human clinical studies ware not conducted using the Digital Thermometer Classic type and Flexible type and predicate devices.

1. Conclusions:
  The Digital Thermometer Classic type and Flexible type have the same intended use and similar technological characteristics as predicate devices. Moreover, any differences in their technological characteristics that do exist would not have a significant effect on the safety or effectiveness of the device. TThus, the Digital Thermometer Classic type and Flexible type are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 21 2002

Mr. Albert Chen General Manager Acute Ideas Company Limited 3F. No. 11. Lane 35. Jihu Road Neihu Dist., Taipei, TAIWAN

Re: K023711

Trade/Device Name: Digital Thermometer Classic Type and Flexible Type Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 29, 2002 Received: November 4, 2002

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 (OS) 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,

[signature]

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: ...............................................................................................................................................................

Device Name: Digital Thermometer Classic Type and Flexible Type

Indications for Use:

The Device measures the human body temperature from oral, axillary, and rectal. -The device is reusable and intended for clinical or home use on people of all ages.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cussinet

of Anesthesiology, General Hospital, n Control, Dental Devices

510(k) Number: K023711

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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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.