The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is a Digital Infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting.

The device is used without a probe cover.

Device Description

The AMPLIFE Digital Infrared Ear Thermometer, Model E100 is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD.

Its operation is based on measuring the natural thermal radiation emanating from the eardrum.

The AMPLIFE Digital Infrared Ear Thermometer, consists mainly of five parts:

a) IR Thermopile Sensor
b) ASIC
c) E2PROM IC
d) LCD and Blacklight
e) Kev2, Buzzer1

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt. This document is a 510(k) summary for a medical device (AMPLIFE Digital Infrared Ear Thermometer, Model E100), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed acceptance criteria and performance metrics in the format you've requested for AI/machine learning models.

However, I can extract the information that is present and indicate what is missing:

Here's an attempt to answer your questions based only on the provided text, highlighting the limitations:

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

The document states compliance with ASTM E1965-98 for thermometry and IEC60601-1 and IEC60601-1-2 for medical electrical equipment safety. These standards contain specific performance criteria (e.g., accuracy, repeatability) for thermometers. However, the exact numerical acceptance criteria from these standards and the specific reported performance of the AMPLIFE device against those criteria are not explicitly detailed in the provided 510(k) summary. It only indicates that "bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness."

For example, ASTM E1965-98 specifies accuracy limits (e.g., ±0.2°C or ±0.3°C depending on the temperature range), but these are not directly presented in a table with the device's measured performance.

Criterion Type	Acceptance Criteria (from referenced standards - not explicitly stated in doc)	Reported Device Performance (not explicitly stated in doc)
Accuracy	(e.g., per ASTM E1965-98, e.g., ±0.2°C or ±0.3°C)	"demonstrate that any differences... do not raise new questions of safety or effectiveness."
Clinical Bias	(Not specified/detailed)	Data was presented (no numerical value provided)
Clinical Uncertainty	(Not specified/detailed)	Data was presented (no numerical value provided)
Clinical Repeatability	(Not specified/detailed)	Data was presented (no numerical value provided)
Safety (Electrical)	(per IEC60601-1, IEC60601-1-2)	Compliance claimed

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

Sample size: The document states "Controlled human clinical studies were conducted," but the exact sample size (number of subjects/measurements) is not provided.
Data provenance: The studies were "Controlled human clinical studies" conducted by "AMPLIFE clinical test protocol for infrared Ear Thermometer." The country of origin is not specified. The studies are implied to be prospective clinical studies as they were "conducted" for this submission.

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

This information is not provided in the document. For a thermometer, "ground truth" often refers to a reference thermometer reading (e.g., rectal thermometer or highly accurate laboratory thermometer) rather than expert consensus on interpretation. The document refers to "clinical bias, clinical uncertainty and clinical repeatability," implying comparison to a reference.

4. Adjudication method for the test set

This information is not provided. Given it's a thermometer measuring a specific physical value, a formal adjudication method (like 2+1 for image reviews) is less likely to be directly applicable compared to a direct comparison against a gold standard reference.

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

MRMC study: No, an MRMC study was not conducted or described. This device is a standalone thermometer, not an AI-powered diagnostic image interpretation tool.
Effect size for human readers with/without AI: This is not applicable as the device is not an AI-assisted diagnostic tool for human readers.

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

Standalone performance: Yes, the device's performance was evaluated in a standalone manner. The device "using an infrared sensor (thermopile) to measure eardrum temperature, then get a reading and display it on the LCD." The "temperature measurements algorithm and its fundamental scientific technology are identical to the predicate device." The "discussion of clinical tests performed" refers to "Controlled human clinical studies were conducted using the AMPLIFE Infrared Ear Thermometer E100." This suggests the device's readings were directly evaluated.

7. The type of ground truth used

The ground truth used would be a reference temperature measurement from an established and highly accurate method (e.g., rectal temperature, or a calibrated standard thermometer) against which the ear thermometer's readings ("clinical bias, clinical uncertainty and clinical repeatability") are compared. The exact method is not explicitly stated, but it's implied by the nature of thermometer testing.

8. The sample size for the training set

This is not applicable in the context of this device. This device is a traditional infrared thermometer, not an AI/machine learning model that undergoes a training phase. Its algorithm is based on established physical principles for infrared thermometry and is stated to be "identical to the predicate device."

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

This is not applicable as there is no "training set" in the context of a traditional thermometer.

Summary

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NOV 19 2004

yagou(l.1.f3)

Exhibit #1

510(K) SUMMARY

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

The assigned 510(k) number is :_______________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

AMPLIFE Corporation 10F. No. 69, Sec. 3, Hue Jung Rd Taichung, Taiwan, R.O.C Tel: +0422587766 Fax: +0422587558

Date Summary Prepared: September 23, 2004

Contact: Mr. Laurence Yang

2. Name of the Device:

AMPLIFE Digital Infrared Ear Thermometer, Model E100

Common Name or Classification Name:

Infrared Ear Thermometer/Clinical Electronic Thermometer

3. Predicate Device Information:

Microlife Intellectual Property GmBH Infrared Ear Thermometer, Model IR1DE1-1, K# 034023.

4. Device Description:

Its operation is based on measuring the natural thermal radiation emanating from the eardrum.

The AMPLIFE Digital Infrared Ear Thermometer, consists mainly of five parts:

a) IR Thermopile Sensor
b) ASIC

c) E2PROM IC

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φ429φb (P.αof3)

d) LCD and Blacklight

e) Kev2, Buzzer1

5. Intended Use:

The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is a digital infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting.

This device is used without a probe cover.

દ. Comparison to Predicate Devices:

The AMPLIFE Digital Infrared Ear Thermometer, Model E100, is substantially equivalent to the Microlife Intellectual Property Digital Ear Thermometer, Model IR1DE1-1, which has the same intended use and is similar in design to the predicate device.

The AMPLIFE Digital Infrared Ear Thermometer. Model E100 and the predicate device are identical in functionality and performance with the difference being the external shape of the devices, and PCB layout of the devices, performance specifications, ergonomics of the user interface, dimensional specifications, The temperature measurements algorithm and its fundamental scientific technology are identical to the predicate device.

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

Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC60601-1 and IEC60601-1-2 requirements.

Guidance documents included the "FDA Guidance on the content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".

Discussion of Clinical Tests Performed: 8.

Controlled human clinical studies were conducted using the AMPLIFE Infrared Ear Thermometer E100. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per AMPLIFE clinical test protocol for infrared Ear Thermometer.

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K442906 (p.3 of 3)

Conclusions: 9.

The AMPLIFE Infrared Ear Thermometer, Model E100, has the same intended use and similar technological characteristics as the Microlife Intellectual Property Infrared Ear thermometer Model IR1DE1-1. Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the AMPLIFE Infrared Ear Thermometer, Model E100, is substantially equivalent to the predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2004

AMPLIFE Corporation C/O Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548

Re: K042906

Trade/Device Name: AMPLIFE Digital Ear Thermometer E100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 15, 2004 Received: November 17, 2004

Dear Mr. Devine:

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.

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 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. Devine

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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), please contact the Office of Compliance at (240) 276-0115. 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 Division 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,

Clus

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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Exhibit B

Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): _ < 0429 Q 6 _______________________________________________________________________________________________________________________________________

Device Name: AMPLIFE Digital Ear Thermometer E100

Indications For Use:

The device is used without a probe cover.

OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use x (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)

in Om

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

510(k) Number: _ Ky 13996

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.