The device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral , armpit , and rectal in neonatal , pediatric and adult population used in the clinical and home testing .

Device Description

The OSTI Temp-Teller High Speed Digital Thermometer(Model DT-302 DT-312 , DT-412 , DT-502) is an electronic thermometer using a thermistor as the temperature sensor . The sensor's electric signal is calculated and displayed by an ASIC (Application Specific IC)
The High Speed digital thermometer comprises: a thermistor for temperature sensing , a reference resistor for comparing the resistance of the thermistor , a buzzer for sounding effect , an ASIC and a LCD display for calculating and displaying the target temperature digitally . The system uses a 1.55 V battery for the power supply and the battery power is automatically check by the ASIC and displayed in LCD if the battery is exhausted .
The OSTI Temp-Teller High Speed Digital Thermometer (Model DT-302 , DT-312 . DT-412 . DT-502) can makes temperature taking faster , its temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+1-2°C .
DT-312 ,DT-412 is high speed digital thermometers, with flexible front tip and with power /measuring button set aside with LCD display and with water resistant function .
DT502 is high speed digital thermometers, with rigid front tip and with power /measuring button set aside with LCD display and with water resistant function .
DT302 is high speed digital thermometers, with rigid front tip and with power /measuring button on top end and with water resistant function .
The DT-302 , DT-312 , DT-412 , DT-502 is identical in functionality and performance .
The essential change include 1)Metal cap / Thermistor mechanical structure change to improve thermal transmission 2)Firm ware 3)Material 4)Shape layout and dimension .
The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.

AI/ML Overview

The provided document K042202 is a 510(k) Pre-Market Notification for the TempTeller-High Speed Digital Thermometer, Models DT302, DT312, DT412, DT502. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than a detailed report of a study proving the device meets specific acceptance criteria in a standalone performance study.

However, based on the information provided, we can infer some details regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states compliance with relevant standards and guidelines, which inherently define the acceptance criteria for a digital thermometer.

Acceptance Criteria (Implied from Standards and Description):
- Accuracy: Temperature measurement accuracy as defined by ASTM E 1112-2000.
- Response Time: Temperature stabilize reading within 10 seconds.
- Safety: Compliance with IEC 601-1-1 and IEC 601-1-2.
- Performance (General): Maintenance of original safety and effectiveness after modifications.
- Functionality: Identical functionality between models and with predicate devices.
Reported Device Performance:
- Response Time: "temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+/-2°C."
- Functionality: "The DT-302, DT-312, DT-412, DT-502 is identical in functionality and performance."
- Safety/Effectiveness: "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness."

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

Sample Size: The document states that "Controlled human clinical studies were conducted," but does not specify the sample size (number of participants or measurements) for these studies.
Data Provenance: The studies were "Controlled human clinical studies," suggesting prospective data collected specifically for this submission. The country of origin of the data is not explicitly stated, though the manufacturer is based in Taiwan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: This information is not provided in the document.
Qualifications of Experts: The document mentions "readings representing a conventional /currently accepted reading by oral or rectal temperature," implying comparison to standard clinical practice, but the personnel establishing the "ground truth" are not specified, nor are their qualifications.

4. Adjudication Method:

The document does not specify any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a "multi reader multi case (MRMC) comparative effectiveness study" focusing on human readers' improvement with AI vs. without AI assistance was not mentioned or implied. This device is a digital thermometer, not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone Performance Study (Algorithm Only):

Yes, a standalone performance assessment was conducted for the device. The document states, "Controlled human clinical studies were conducted using the OSTI Temp Teller Thermometer," and that "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness." This implies the device was tested on its own to confirm its temperature measurement capabilities.
Specifically, the performance claim of "temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+/-2°C" is a standalone performance metric.

7. Type of Ground Truth Used:

The ground truth for the clinical studies was implicitly based on "conventional /currently accepted reading by oral or rectal temperature." This typically refers to medical standards for temperature measurement, likely involving a reference thermometer or established clinical methods, but exact details are not provided.

8. Sample Size for the Training Set:

The document describes a modified device that has undergone changes to its "Metal cap / Thermistor mechanical structure," "Firmware," "Material," and "Shape layout and dimension." While "Firmware" suggests software, the document does not mention any machine learning or AI components that would require a 'training set.' Therefore, this question is not applicable in the context of this device and documentation.

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

As there is no mention of a training set for machine learning/AI, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Oriental System Technology Inc. The logo consists of a stylized eye-like symbol on the left, followed by the company name in a simple, sans-serif font. The text is arranged in two lines, with "ORIENTAL SYSTEM" on the top line and "TECHNOLOGY INC." on the bottom line.

K042202

SEP 1 0 2004 510(K) Summary

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

The assigned 510(k) number is:

1. Submitter's Identifications:

Oriental System Technology Inc. 2F No.23, Industry E, Road 9th, Science Based Industrial Park Hsinchu, Taiwan, R.O.C

Contact:

Mr. Herman Lee General Manager

Date of Summary Preparation: August 12, 2004

2. Name of the Device:

TempTeller-High Speed Digital Thermometer , Model DT302 , DT312 , DT412,DT502

3. Information of the 510(k) Cleared Device (Predicate Device):

1. TempTeller- Digital Thermometers, Model DT-102
  510(k) Number: K#992601

2.VICKS - Speed Read Digital Thermometer , Model V911 , V965

4. Device description:

The High Speed digital thermometer comprises: a thermistor for temperature sensing , a reference resistor for comparing the resistance of the thermistor , a buzzer for sounding effect , an ASIC and a LCD display for calculating and displaying the target temperature digitally . The system uses a 1.55 V battery

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Image /page/1/Picture/0 description: The image shows a black and white logo. The logo consists of a circle with a spiral design inside. The spiral design has a small circle in the center. The logo is simple and modern.

ORIENTAL SYSTEM
TECHNOLOGY INC

for the power supply and the battery power is automatically check by the ASIC and displayed in LCD if the battery is exhausted .

The OSTI Temp-Teller High Speed Digital Thermometer (Model DT-302 , DT-312 . DT-412 . DT-502) can makes temperature taking faster , its temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+1-2°C .

DT-312 ,DT-412 is high speed digital thermometers, with flexible front tip and with power /measuring button set aside with LCD display and with water resistant function .

DT502 is high speed digital thermometers, with rigid front tip and with power /measuring button set aside with LCD display and with water resistant function .

DT302 is high speed digital thermometers, with rigid front tip and with power /measuring button on top end and with water resistant function .

The DT-302 , DT-312 , DT-412 , DT-502 is identical in functionality and performance .

The essential change include 1)Metal cap / Thermistor mechanical structure change to improve thermal transmission 2)Firm ware 3)Material 4)Shape layout and dimension .

The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.

5. Intended Use:

6. Comparison to Predicate Devices:

The OSTI Temp Teller High Speed Digital Thermometer , Model DT-301,DT-312 , DT-412 .DT-502are substantially equivalent to the following digital thermometers.

TempTeller- Digital Thermometers, Model DT-102

510(k) Number: K#992601

2.VICKS -- Speed Read Digital Thermometer , Model V911 , V965

The OSTI Temp Teller High Speed Digital Thermometer , Model

DT-301,DT-312 ,DT-412 ,DT-502 have the same intended use as and are similar in design to the 510(k) cleared device.

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Image /page/2/Picture/0 description: The image shows the logo for Oriental System Technology Inc. The logo consists of a circular symbol on the left and the company name on the right. The circular symbol is a stylized design with a swirling pattern inside a circle. The company name is written in a simple, sans-serif font.

K042202
3 of 3

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

Compliance to applicable voluntary standards include ASTM E 1112-2000 , as well as IEC 601-1-1 and IEC 601-1-2 requirements.

FDA Guidance documents include the" Deciding When to Submit a 510(k) for a Change to An Existing Device" and "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".

8.Discussion of Clinical Tests Performed :

Controlled human clinical studies were conducted using the OSTI Temp Teller Thermometer and predicate devices . Clinical data is presented with readings representing a conventional /currently accepted reading by oral or rectal temperature .

9. Conclusions

The OSTI TempTeller -High Speed Digital thermometers, model DT302 , DT312 , DT412,DT502 have the same intended use and technological characteristics as the 510(k) cleared device. Moreover, verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness. Those engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific of the device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2004

Oriental System Technology, Incorporated C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck. New York 11021

Re: K042202

Trade/Device Name: Temp Teller-High Speed Digital Thermometers, Models DT-302, DT-312, DT-412, DT-502 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 3, 2004 Received: September 7, 2004

Dear Ms. Goldstein-Falk:

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 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 (1 wr ), it hay of cash 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 - Ms. Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rood that 12 a determination that your device complies with other requirements mount that I Drivinederal statutes and regulations administered by other Federal agencies. or the receir any a 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 alle listing (2) es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as better in 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) I mill letter 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), n you don't the Office 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 maj obtain 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,

Cluts

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

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K042202

Exhibit B

1 of of 1 Page

510(k) Number (if known): _

Device Name: Oriental System Technology Inc. Temp Teller High Speed Digital Thermometers, Models DT-32, DT-312, DT-412, DT502.

Indications For Use:

The device is an electronic clinical thermometer using a thermistor to The device is an olootronify on the oral, armpit and rectal in the neonatal, pediatric and adult population used in clinical and home testing.

Prescription Use (Per 21 CFR 801 Subpart D)

Irene Naveau for ADW 9/10/04

Over-The Counter Use

(21 CFT 807 Subpart C)

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices

510(k) Number: K042202

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.