Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 by JKH HEALTH CO., LTD.

Based on the provided FDA 510(k) clearance letter and Indications for Use, the document does not contain detailed information about the specific acceptance criteria for performance, the study design, sample sizes, expert qualifications, or ground truth establishment that would typically be found in a clinical study report or detailed submission summary.

The document primarily focuses on the regulatory clearance process, confirming that the device (Infrared Thermometer, Models: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304) is substantially equivalent to legally marketed predicate devices. It states its intended use for non-contact temperature measurement for people of all ages at home or in a hospital setting.

Therefore, many of the requested details cannot be extracted from this particular document. I will highlight what can be inferred or is directly stated, and mark what is not present.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
(Typically would include accuracy, precision, bias, measurement range, e.g., "Accuracy +/- 0.2°C at 37.0°C")	(e.g., "Accuracy was measured as +/- 0.15°C for 95% of readings")

2. Sample sized used for the test set and the data provenance

Sample size: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Adjudication method: Not specified.

5. 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

MRMC study: Not applicable. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results.
Effect size of human improvement with AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance: Yes, this is an inference given the device's nature as an infrared thermometer. Its performance would be evaluated as a standalone device without human interpretation of its core function (temperature measurement). However, the specific details of this testing (e.g., how accuracy was validated against a reference standard) are not provided in this document.

7. The type of ground truth used

Type of ground truth: Not explicitly stated. For a thermometer, the ground truth would typically be a highly accurate reference thermometer measurement (e.g., a laboratory-grade precision thermometer, or an invasive core body temperature measurement in a clinical setting for calibration/validation).

8. The sample size for the training set

Sample size for training set: Not applicable and not specified. Infrared thermometers typically do not involve "training sets" in the machine learning sense. Their calibration and performance are based on physical principles and manufacturing processes, demonstrated through verification and validation testing.

9. How the ground truth for the training set was established

Ground truth for training set: Not applicable and not specified. See point 8.

Summary of what's provided for the JKH Health Co., Ltd. Infrared Thermometer:

Device Name: Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
Regulation Number/Name: 21 CFR 880.2910, Clinical Electronic Thermometer
Regulatory Class: Class II
Product Code: FLL
Intended Use: Temperature measurement at home or hospital for people of all ages without contact to the human body.
Type of Use: Over-The-Counter Use
Regulatory Status: Cleared via 510(k) (K211050) as substantially equivalent to predicate devices.

What is NOT provided in this FDA 510(k) clearance letter (and would typically be found in a detailed test report or submission summary):

Specific numerical acceptance criteria for accuracy, precision, or other performance characteristics.
Detailed results of the device's performance against these criteria.
Information about the clinical or laboratory studies conducted (e.g., number of subjects, age groups, measurement sites, comparison methods, statistical analysis).
Any information regarding training data, ground truth establishment, or expert involvement, as these are more pertinent to AI/ML-driven devices.

Summary

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November 28, 2022

JKH Health Co., Ltd. % Bill Quanqin Dai Manager JKH USA. LLC 3 Whatney. #102B Irvine, California 92618

Re: K211050

Trade/Device Name: Infrared Thermometer, Model: JKH-301, JKH-302, JKH-302, JKH-303, JKH-304 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 10, 2022 Received: October 28, 2022

Dear Bill Quanqin Dai:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Danil Walloschek

David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211050

Device Name

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304

Indications for Use (Describe)

Infrared Thermometer is intended temperature measurement at home or hospital for people of all ages without contact to human body.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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.