The Infrared Ear Thermometer, models IR-04MT are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.

Device Description

The Infrared Ear Thermometer, models IR-04MT is a handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) – controlled circuit, which is considered the hard-wire control instead of programmable control.

From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.

This system uses a 3.0 V DC battery(2xAAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of IR-04MT, they were designed and verified according to the US standard ASTM E 1965-2003.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Ear Thermometer, models IR-04MT:

1. Table of Acceptance Criteria and Reported Device Performance

Despite multiple references to performance and compliance with ASTM E1965-2003, the document does not explicitly state specific numerical acceptance criteria for accuracy (e.g., a specific deviation tolerance) or the exact reported performance metrics from the clinical study in an easily quantifiable format. It broadly states the device "was designed and verified according to the US standard ASTM E 1965-2003" and that "The results of the Clinical Test Report could positively support the claim of Substantial Equivalence."

To fulfill this section accurately, I can only infer the acceptance criteria are met by compliance with the referenced standard.

Acceptance Criterion (Inferred from ASTM E1965:2003 compliance)	Reported Device Performance
Compliance with ASTM E1965:2003 for Infrared Ear Thermometers	Device "designed and verified" and "performance compliance test conducted" according to ASTM E1965:2003.Clinical Test Report "positively support[s] the claim of Substantial Equivalence."
Electrical Compliance (IEC 60601-1)	"Electrical Compliance Test according to IEC 60601-1 by accredited laboratory."
EMC Compliance (IEC 60601-1-2)	"EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory."
Operability within specified range	The document implies the device met its specified operation range, though the range itself is not detailed. (Implied by "the measuring specification (including operation range, accuracy, measurement time)")
Accuracy within specified limits	Implied to meet limits set by ASTM E1965:2003. No specific deviation or error range reported. (Implied by "the measuring specification (including operation range, accuracy, measurement time)")

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

Test Set Sample Size: Not explicitly stated. The document mentions "A Clinical Test Report conducted according to ASTM E1965:2003" but does not provide the number of subjects or measurements included in this test.
Data Provenance: The study was conducted by the "manufacturer," which is DONGGUAN DALANG VIGOR ELECTRONICS MFY in China. Therefore, the data provenance is China. It is a prospective study, as it was a "Clinical Test Report conducted... performed by the manufacturer" as part of the device's validation.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth. The nature of an ear thermometer's ground truth (e.g., a reference rectal or oral temperature measured by a calibrated clinical thermometer) typically doesn't involve "experts" in the sense of radiologists or pathologists. Instead, it relies on the accuracy of the reference device and the methodology for its use.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. For a device like an ear thermometer, "adjudication" in the traditional sense of multiple reviewers resolving discrepancies is not typically applicable. The ground truth is generally a single, objectively measured value from a reference method.

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

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images, sometimes with AI assistance. The Infrared Ear Thermometer is a direct measurement device, not an interpretative one, and does not involve AI assistance for human readers.

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

Yes, this is effectively a standalone performance study. The device itself is an "algorithm only" (ASIC-controlled circuit) device that measures and displays temperature. Human involvement is limited to operating the device (placing it in the ear canal and reading the display), not interpreting complex output that would require a "human-in-the-loop" interaction in the typical sense of AI-assisted diagnostics. The clinical test measured the device's accuracy against a recognized standard without a human interpretation component that would require comparison to human-in-the-loop scenarios.

7. The Type of Ground Truth Used

The ground truth used would be a reference temperature measurement obtained by a calibrated clinical thermometer following the guidelines of ASTM E1965:2003. This standard details how to conduct clinical performance evaluations for infrared thermometers. It implies a direct comparison to a known accurate temperature measurement from a standard clinical method (e.g., a rectal thermometer) under controlled conditions.

8. The Sample Size for the Training Set

The document does not mention a specific training set or its sample size. This device is described as having an "ASIC (Application Specific IC) – controlled circuit," which is a "hard-wire control instead of programmable control." This implies a fixed, hardware-based algorithm rather than a software algorithm that would undergo a separate "training" phase with a dataset. Therefore, the concept of a "training set" as understood in machine learning/AI (which wasn't the focus of this device) does not apply here.

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

As there is no indicated "training set" in the context of an ASIC-controlled, hard-wired device that is not an AI/machine learning product, this question is not applicable. The device's fundamental function is governed by its hardware design and integrated circuit, which are designed to comply with physical principles of thermometry.

Summary

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510(K) SUMMARY

JAN 1 4 201

This summary of 510/k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at September 25, 2010.

The assigned 510(k) number is: K102934

Submitter's Identifications: Establishment: DONGGUAN DALANG VIGOR ELECTRONICS MFY. Yang Wu District, Da Lang Town, Dong Guan City Guang Dong Prov., CHINA Registration Number: 9616843 Operations: Manufacturer Status: Active Date Of Registration Status: 2004

Owner/Operator: VEGA TECHNOLOGIES, INC. 11F-13, 100 Chang-Chun Rd., Taipei CHINA (Taiwan) 104. Owner/Operator Number: 9036509

Contact: Mr. Joseph Lu VEGA TECHNOLOGIES, INC. I1F-13, 100 Chang-Chun Rd. Taipei, CHINA (TAIWAN) 104 Phone: 886-2-2541-6996 Fax: 886-2-2521-3803

1. Name of the Device: Infrared Ear Thermometer, models IR-04MT.
Information of the 510(k) Cleared Device (Predicate Device): 3. ST613C and ST614F (K011254).

4. Device Description:

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5. Intended Use:

The Infrared Ear Thermometer / model IR-04MT is a battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use on people at all ages.

6. Comparison to the 510(k) Cleared Device (Predicate Device):

The Infrared Ear Thermometer, models IR-04MT is substantially equivalent to the Mesure model ST613C and ST613F(K011254). The main technological modification made to IR-04MT as it relates to the predicate device includes the following four issues:

the measuring specification(including operation range, accuracy, measurement time) 1>
the operation and storage environment range. 2>
the device outlook, dimensions, and weight. 3>
the main measuring and control IC and circuit, as well as software. 4>
1. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of IR-04MT are as the followings:
- 1> Performance Compliance Test according to ASTM E1965:2003 conducted by manufacturer
- 2> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory.
- 3> EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
1. Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device are as the followings:

A Clinical Test Report conducted according to ASTM E1965:2003 performed by the manufacturer was included as part of ASTM E1965 conformity test report. This report was carried out in such a way that compared the accuracy performance between IR-04MT and the predicate device according to the method recommended in ASTM E1965 standard.

The results of the Clinical Test Report could positively support the claim of Substantial Equivalence for IR-04MT against the chosen 510K predicate device.

1. Conclusions
  .

The Infrared Ear Thermometer, model IR-04MT, has the same intended use and technological characteristics as the cleared device of Mesure model ST613C and ST614F(K011254). onareover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Indications For Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Infrared Ear Thermometer / Models IR-04MT.

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 1 __

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Joseph Lu VEGA Technologies, Incorporated 11F-13, 100 Chang-Chun Rd., Taipei CHINA ( Taiwan) 104

JAN 1 4 2011

Re: K102934

Trade/Device Name: Infrared Ear Thermometer / Models IR-04MT Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 21, 2010 Received: December 22, 2010

Dear Mr. Lu:

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. 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.

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Page 2- Mr. Lu

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1] 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportallroblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fos

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications For Use

510(k) Number (if known):

Device Name: Infrared Ear Thermometer / Models IR-04MT.

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rld C. Chapa 1/12/11

(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, $$$2000 Total Division Control, Dental Device

510(k) Number: K102934

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.