The Digital Thermometer, models MT-XX8 and MT-XX9 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.

Device Description

The Digital Thermometers, models MT-XX8 and MT-XX9, are the electronic themometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) control instead of programmable control. Basically MT-XX8 and MT-XX9 have the same control and only the different measuring range caused by some small different design in IC circuit. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery 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.

AI/ML Overview

The provided text describes the submission for a 510(k) premarket notification for the VEGA TECHNOLOGIES, INC. Digital Thermometers, models MT-XX8 and MT-XX9. It focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant standards, rather than providing detailed acceptance criteria and a comprehensive study report with the specific information requested.

Therefore, many of the requested details cannot be extracted from the given document.

Here's an attempt to answer what can be inferred:

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

The document states that the performance of MT-XX8 and MT-XX9 was "designed and verified according to the US standard ASTM E1112-98". This standard sets the acceptance criteria for electronic thermometers. However, the specific values for the acceptance criteria from ASTM E1112-98 (e.g., accuracy ranges) and the reported device performance directly measured against these criteria are not present in the provided text. The text only says it was "designed and verified according to" the standard.

Acceptance Criteria (Based on ASTM E1112-98)	Reported Device Performance (Not explicitly stated in the document, but verified to meet the standard)
(Specific accuracy ranges for different temperature ranges as defined in ASTM E1112-98)	(The device was designed and verified to meet these standards. No numerical performance results are provided.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "verification and validation tests contained in this submission," but does not detail the sample size, type of test set (e.g., human subjects, calibration blocks), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. For a digital thermometer, "ground truth" would typically be established by a highly accurate reference thermometer in a controlled environment, not by human experts in the way it would be for image analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is typically used for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The described device is a standalone electronic thermometer, not an AI-assisted diagnostic tool.

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

Yes, a standalone performance assessment was conducted in the sense that the device's accuracy was "designed and verified according to the US standard ASTM E1112-98." This standard dictates performance testing of the device itself, independent of human interpretation or involvement beyond operating the device. However, specific performance metrics are not listed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a digital thermometer, the ground truth would typically be established using calibrated reference thermometers and controlled temperature environments, in accordance with standards like ASTM E1112-98. The document does not explicitly state this, but it is implied by the reference to the standard.

8. The sample size for the training set

This information is not provided. The device is an electronic thermometer controlled by an ASIC (Application Specific Integrated Circuit) with hard-wired control, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

As explained in point 8, the concept of a "training set" and "ground truth for training" as typically used for AI algorithms is not applicable to this device. Its function is based on thermistor physics and established electronics, not a learnable model. The design and verification would rely on fundamental engineering principles and calibration against known temperature standards.

Summary

{0}------------------------------------------------

VEGA TECHNOLOGIES, INC.

510(K) SUMMARY

SEP = 8 2004

This summary of 510(k) safety and effectiveness information is being submitted in accordance with This Sammary of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________

Submitter's Identifications: Establishment: 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. VEGA TEOHNOEOOLES, II. Taipei, CHINA (TAIWAN) 104 Phone: 886-2-2541-6996 Fax: 886-2-2521-3803

1. Name of the Device: Name on the Device: MT-XX8 and MT-XX8 and MT-XX9.
1. Information of the 510(k) Cleared Device (Predicate Device): ST8631 (K021048).

4. Device Description:

The Digital Thermometers, models MT-XX8 and MT-XX9, are the electronic themometers by i he Digital Themistor as the temperature sensor. The signal of sensor is calculated and displayed using a thermistor as the temperature sonton: The organs of on is considered the hard-wire by an ASIC (Application Openile 10)
control instead of programmable control. Basically MT-XX8 and MT-XX9 have the same control firstead on programmable control and on the different measuring range caused by some small different design in IC circuit.

{1}------------------------------------------------

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

This system uses a 1.5V DC battery 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 MT-XX8 and MT-XX9, it was designed and verified according to the US standard ASTM E1112-98.

5. Intended Use:

The Digital Thermometer, models MT-XX8 and MT-XX9 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be used in the measurement of oral, axially and rectal temperature.

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

The Digital Thermometer, models MT-XX8 and MT-XX9 are substantially equivalent to the Mesure model ST861 (K021048).

7 . Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

8. Conclusions

The VEGE Digital thermometer, including MT-XX8 and MT-XX9, have the same intended use and technological characteristics as the cleared device of Mesure model ST8631 (K021048). Moreover, 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's seal. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Mr. Joseph Lu General Manager Vega Technologies, Incorporated 11F-13, 100, Chang-Chun Road, Taipei CHINA (TAIWAN) 104

Re: K041516

Trade/Device Name: Digital Thermometer/ Models MT-XX8 and MT-XX9 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 21, 2004 Received: August 27, 2004

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 approvisions of the Act. The general controls provisions of the Act include controls provisions on 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 (1 Nr.), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device a may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Lu

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements nical that I DA nas made statutes and regulations administered by other Federal agencies. or the rice of arry - with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and are labeling (21 CFR Part 801); good manufacturing practice alled instills (21 CF refr in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as better 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) This lottor wification. The FDA finding of substantial equivalence of your device to a premaired 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), If you desire specific at a work of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn 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,

Chiu Lin, Ph.D.

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

Enclosure

{4}------------------------------------------------

	Indications For Use
510(k) Number (if known):	K041516
Device Name:	Digital Thermometer / Models MT-XX8 and MT-XX9.
Indications For Use:	The Digital Thermometer, models MT-XX8 and MT-XX9 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.
Prescription Use(Part 21 CFR 801 Subpart D)	OR
	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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:	K041516
	Page 1 of 1

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.