The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Device Description

The OSTI Temp - Teller Infrared Tympanic Thermometer, Models TT-200, TT-201, is an electronic thermometer using an infrared sensor (pyroelectric heat sensor, employing the principle of the electrically calibrated pyroelectric radiometer (ECPR)) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

OSTI Temp -Teller Infrared Tympanic Thermometer, Model TT-201, consists mainly of five parts: an IR sensor, a barrel, a shutter, an ambient temperature sensor, and the associated circuit.

The ear canal guides sound to the eardrum, which is thin and flooded with blood at the core temperature. The barrel, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer canal without contracting the eardrum. The shutter controls when the flux is transferred to the IR sensor. When the shutter is open, radiative fluxes transfer among the tympanum, the IR sensor, and the inner surface of the barrel. The ambient sensor is mounted near the IR sensor to monitor the ambient temperature.

To measure core temperature, a tympanic thermometer is inserted into a patient's outer ear canal. A start button is pressed to open the shutter momentarily and to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a display. The total operation takes a few seconds.

AI/ML Overview

The provided text describes the OTI Temp Teller-Infrared Tympanic Thermometer, Models TT-200 and TT-201, and its substantial equivalence to predicate devices, but it does not explicitly state specific acceptance criteria (numerical thresholds for accuracy, precision, etc.) or detailed results from the clinical study that would directly allow for filling out a table of acceptance criteria and reported performance.

However, I can extract information related to the study and provide what is available, noting the limitations.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of numerical accuracy or precision requirements. The text mentions compliance with "applicable voluntary standards includes ASTM E1112 and ASTM E1104," which would contain such criteria. Without access to those standards, the specific numerical thresholds are unstated in this document.
Reported Device Performance: The document generally states that "clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This is a qualitative statement of equivalence, not a quantitative report of performance against specific metrics.

Therefore, a table cannot be fully populated with specific numerical values based only on the provided text.

2. Sample size used for the test set and the data provenance:

Sample Size: "The number of patients have been statistically justified." The specific number is not provided.
Data Provenance: "Controlled human clinical studies were conducted," and the patient population "is well represented (neonatal, pediatrics and adults)." This indicates a prospective clinical study with participants from potentially diverse age groups, though specific country of origin is not mentioned.

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

Not specified. The ground truth was established by "standard oral/rectal thermometers with readings representing a conventional/currently accepted reading." There's no mention of experts establishing a consensus ground truth in this context.

4. Adjudication method for the test set:

Not applicable/Not specified. The comparison was against "standard oral/rectal thermometers," which are considered the reference. No human adjudication process for the test set itself is described beyond comparing the device readings to these reference measurements.

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:

No. This device is a thermometer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.

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

Yes, this was a standalone device performance study. The device itself measures temperature and provides a reading. There isn't a "human-in-the-loop" aspect to its fundamental operation beyond taking the measurement. The clinical studies evaluated the device's inherent accuracy compared to reference methods.

7. The type of ground truth used:

Reference method/Comparative measurement: "Standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral."

8. The sample size for the training set:

Not applicable/Not specified. This device is a traditional electronic thermometer (using an IR sensor and associated circuitry) and the document does not describe it as an AI/machine learning device that would require a "training set" in the conventional sense. The "training" in such devices typically refers to engineering calibration and algorithmic design, not a data-driven machine learning approach described with a 'training set'.

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

Not applicable. As noted above, there's no mention of a training set for an AI/ML algorithm.

In summary, the provided document focuses on establishing substantial equivalence by aligning with predicate devices and voluntary standards, and by conducting clinical studies comparing its readings to conventional thermometers. However, it lacks the detailed quantitative performance metrics and specific study participant numbers that would typically be required to fully answer all the posed questions.

Summary

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K984497

EXHIBIT # 1

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:________________________________________________________________________________________________________________________________________________

Submitter's Identification: 1.

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

Contact:

Mr. Herman Lee General Manager

Date Summary Prepared: November 1998

2. Name of the Device:

Temp Teller-Infrared Tympanic Thermometer, Models TT-200 and TT-201

3. Predicate Device Information:

ThermoScan Instant Thermometer, K# 902912, K# 930680, K# 954523 and K# 964605, ThermoScan Inc.

Omron Gentle Temp MC 505, K# 922344, Omron Health Care.

4. Device Description:

OSTI Temp -Teller Infrared Tympanic Thermometer, Model TT-201, consists mainly of five parts: an IR sensor, a barrel, a shutter, an ambient temperature sensor, and the associated circuit.

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5. Intended Use:

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

6. Comparison to Predicate Devices:

The OSTI Temp Teller - Infrared Tympanic Thermometer. Models TT-200 and TT-201 are substantially equivalent to the following infrared ear thermometers.

ThermoScan Instant Thermometer, K# 902912, K# 930680, K# 954523 and . K# 964605, ThermoScan Inc. and.
Omron Gentle Temp MC 505, K# 922344, Omron Health Care. .

The OSTI Temp Teller is similar in design and intended use to the predicates differing only in the infrared sensor used with auto calibration and/or method used to determine/control the reference temperature.

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

Compliance to applicable voluntary standards includes ASTM E1112. and ASTM E1104, as well as IEC 60601-1 and IEC 60601-1-2 requirements.

Guidance Documents included the FDA "Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".

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Discussion of Clinical Tests Performed: 8.

Controlled human clinical studies were conducted using the OSTI Temp Teller Thermometer and predicate devices. Clinical data is presented comparing the IR thermometers to standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral. The patient population is well represented (neonatal, pediatrics and adults), and the number of patients have been statistically justified.

9. Conclusions:

The OSTI Temp Teller - Infrared Tympanic Thermometer, Models TT-200 and TT-201, have the same intended use and similar technological characteristics as the ThermoScan Instant Thermometer and Omron Gentle Temp MC 505 devices. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the OSTI Temp Teller Infrared Tympanic Thermometer, Models TT-200 and TT-201 is substantially equivalent to the predicate devices.

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 1999

Oriental System Technology, Incorporated c/o Ms. Susan D. Goldstein-Falk Official Correspondent for MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 11021 Great Neck, NY

Re : K984497 Temp Teller® Infrared Instant Ear Trade Name: Thermometer Model TT-201 Regulatory Class: II Product Code: FLL Dated: April 1, 1999 Received: April 5, 1999

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Paqe 2 - Ms. Goldstein-Falk

this response to your premarket notification Please note: ribuission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asborizon 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Runov

rTimothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

of Page _ 1

510(k) Number (if known): __

Device Name: Oriental Systems Technology Inc. Temp – Teller – Infrared Tympanic Thermometer, Models TT-200, TT-201

Indications For Use:

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

Palma Crescent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

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.