The device measures the body temperature of a patient by means of a sensor (transducer) coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

Device Description

The shaker digital thermometer, model ST8S Series, are the electronic thermometers by using a thermistor 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 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. ST8S uses a hand shaking power generation mechanism to generate the electrical power required for short time temperature measurement operation. Whenever the generated power is low, the device as well as LCD display are switched off automatically. Regarding the performance of ST8S Series, it was designed and verified according to the US standard ASTM E 1112-00.

AI/ML Overview

The provided text describes a 510(k) summary for a Shaker Digital Thermometer. However, it does not include the detailed information required to answer all the questions about acceptance criteria and a study proving device performance as typically expected for advanced AI/ML medical devices. The document focuses on regulatory equivalence to a predicate device based on standard compliance rather than clinical performance studies.

Here's a breakdown of what can and cannot be extracted from the provided text:

What can be extracted:

Acceptance Criteria and Reported Device Performance: This device's "performance compliance" is directly tied to the voluntary standard ASTM E1112-00. The text states:
- "Regarding the performance of ST8S Series, it was designed and verified according to the US standard ASTM E 1112-00."
- "Compliance is ensure via the following voluntary standard testing reports: 1> ASTM E1112-00 for device performance compliance tested by manufacturer."
The document doesn't provide specific numerical acceptance criteria (e.g., accuracy, precision values) from ASTM E1112-00, nor does it list the reported device performance results against those numerical criteria. It only states that the device "was designed and verified according to" and achieved "compliance" with the standard.

To fully answer this, one would need to refer to the ASTM E1112-00 standard itself, which would define the acceptance criteria for clinical electronic thermometers (e.g., accuracy limits, response time, stability). Since the 510(k) states compliance, the reported performance is implicitly within the limits set by that standard.

What cannot be extracted (and why):

The following questions are typically relevant for AI/ML or more complex diagnostic devices involving clinical studies, which are not described in this 510(k) for a digital thermometer:

Sample sized used for the test set and the data provenance: Not applicable/not provided. Performance was verified against a standard in a lab setting, not a clinical test set with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No expert ground truth was established for "test sets" in the context of this device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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. This is a standalone digital thermometer, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of AI algorithms. The device functions as a standalone thermometer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a thermometer, the "ground truth" for performance testing (as per ASTM E1112-00) would typically involve comparison to highly accurate reference thermometers under controlled environmental conditions, rather than expert consensus or pathology. The document doesn't specify the exact ground truth methodology used within the ASTM E1112-00 testing.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary Table of Available Information:

Section	Information from Document
Acceptance Criteria & Reported Device Performance	Acceptance Criteria: Derived from ASTM E1112-00 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature). The specific numerical criteria (e.g., maximum allowable error at different temperature ranges) are not explicitly stated in this document but are defined by the standard. Reported Device Performance: The device "was designed and verified according to the US standard ASTM E 1112-00" and "Compliance is ensure via the following voluntary standard testing reports: 1> ASTM E1112-00 for device performance compliance tested by manufacturer". This implies the device's performance meets the criteria specified in ASTM E1112-00. Specific performance values (e.g., actual accuracy measurements) are not provided.
Sample size (test set) & data provenance	Not applicable for this type of device and submission. Performance verification against a standard typically involves laboratory testing, not a clinical "test set" from patient data.
Number & qualifications of experts for ground truth (test set)	Not applicable.
Adjudication method (test set)	Not applicable.
MRMC comparative effectiveness study? Effect size of human readers with/without AI assistance?	Not applicable. This is a digital thermometer, not an AI-assisted diagnostic device.
Standalone (algorithm only) performance study?	The device itself is a standalone digital thermometer. This question, in the context of AI, is not applicable.
Type of ground truth used	Likely highly accurate reference thermometers or calibrated temperature sources as per ASTM E1112-00 methodology. Not explicitly stated in the document.
Sample size for training set	Not applicable. This is not an AI/ML device.
How ground truth for training set was established	Not applicable. This is not an AI/ML device.

Conclusion regarding the study proving device meets acceptance criteria:

The study that proves the device meets its acceptance criteria is the performance compliance testing conducted by the manufacturer according to the US standard ASTM E1112-00. The 510(k) submission asserts that this testing demonstrated compliance, thereby proving the device meets the performance specifications defined within that standard. No further details about the study methodology, sample size, or specific results are provided in this regulatory summary, as is common for predicate-based 510(k) submissions which rely on compliance with recognized standards.

Summary

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Mesure Technology Co., Ltd.

510(K) SUMMARY

OCT - 4 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, and the relevant 510(k) submission guidance on September 30, 2011.

The assigned 510(k) number is: K112703 Submitter's Identifications: Company: Mesure Technology Co., Ltd. Address: 7F, No. 88, Sec. 1, Kwang Fu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C. Contact person: Rack Yu. Telephone Number : +886-2-8512-2747

1. Name of the Device:
  Trade Name : Shaker Digital Thermometer, model ST8S Series Common Name : Shaker Digital Thermometer, model ST8S Series. Classification Name : Clinical Electronic Thermometer
1. Information of the 510(k) Cleared Device (Predicate Device): Digital Clinical Thermometer, model ST-833A, and ST-834A (K981337)
1. Device Description:

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.

ST8S uses a hand shaking power generation mechanism to generate the electrical power required for short time temperature measurement operation. Whenever the generated power is low, the device as well as LCD display are switched off automatically. Regarding the performance of ST8S Series, it was designed and verified according to the US standard ASTM E 1112-00.

র্ব Intended Use:
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

5. Contraindication:

For oral and rectal temperature measurement, the FDA 510(K) cleared and listing disposable probe cover shall be used for each measurement to prevent the risk of cross-infection

ల్ Compatible Accessory :

Yu Long Sheng Disposable Thermometer Sheath(Probe Cover); model YLS-01(K012508); This compatible accessory shall be used for the oral and rectal temperature measurement.

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Mesure Technology Co., Ltd.

1. Comparison to the 510(k) Cleared Device (Predicate Device);
  Since the new models ST8S Series were developed from the cleared device ST-833A, and ST-834A through the design control procedures of Measure Technology Co., Ltd, with only the small change in power supply system and device housing, the new device is substantial equivalence to that of device being modified. ST-833A, and ST-834A.

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

Compliance is ensure via the following voluntary standard testing reports:

1> ASTM E1112-00 for device performance compliance tested by manufacturer
2> EN/IEC 60601-1 for electrical safety compliance tested by accredited laboratory
3> EN/JEC 60601-1-2 for EMC compliance tested by accredited laboratory.

9. Conclusions

The Mesure shaker digital thermometer, models ST8S Series have the same intended use and technological characteristics as the cleared device of Measure's model ST-833A, and ST-834A. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate 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. Therefore: we concluded that the Mesure shaker digital thermometer, model is substantial equivalent to the Measure's model ST-833A. and ST-834A(K981337)

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circular border.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Rack Yu OC & President Measure Technology Company, Limited 7F. No. 88. Sec. 1. Kwang Fu Road Sanchung City. Taipei Hsien Taiwan, R.O.C.

OCT - 4 2011

Rc: K112703

Trade/Device Name: Shaker Digital Thermometer, Models ST8S Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 14, 2011 Received: September 16, 2011

Dear Mr. Yu:

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. Yu

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/ucm115809.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/ReportalProblem /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,

Susan Runoen

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

Enclosure

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Mesure Technology Co., Ltd.

Indications For Use

510(k) Number (if known):_ K112703

Device Name: Shaker Digital Thermometer, Models ST8S Series

Indications For Use:

Contraindication:

For oral and rectal temperature measurement, the FDA 510(K) cleared and listing disposable probe cover shall be used for each measurement to prevent the risk of cross-infection.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use ア (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

112703 510(k) Number:

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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.