The device is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Device Description

AVITA TS8/TS9 IR Ear/ Forehead Thermometer is a hand-held, non-sterile, reusable, battery operated device that can measures human body temperature in 2 ways (1) the temporal artery over forehead.. (2) Tympanic Temperature via the human ear. Operation is based on the measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear Tympanic .

AI/ML Overview

The provided text describes the AVITA TS8/TS9 Series IR Ear/Forehead Thermometer, its intended use, and its substantial equivalence to predicate devices. However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics from a dedicated clinical trial.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not present in this document. The document primarily focuses on conforming to general standards and demonstrating similar technological characteristics to predicate devices.

Here's a breakdown of what can be extracted and what is missing:

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

This information is not explicitly provided in the document. The filing states:

"In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included ASTM E1965-98, IEC 60601-1 and IEC 60601-1-2 requirements."

This indicates that compliance with these general standards serves as a form of acceptance criteria for various aspects (safety, electromagnetic compatibility, general performance), but it does not specify quantitative performance metrics for temperature accuracy. For example, ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) would contain accuracy requirements, but the specific measured performance of the AVITA device against those requirements is not detailed in this summary.

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

The document mentions "clinical testing supplied" but does not specify the sample size used for the test set.
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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. The document makes no reference to experts or their qualifications for establishing ground truth.

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

This information is not provided. The document does not describe any adjudication process.

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, a multi-reader, multi-case comparative effectiveness study was not mentioned or implied. This device is a medical thermometer, 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

This question is not applicable in the context of a thermometer. The device itself is standalone in its measurement function, and its performance would be evaluated as such. There is no "algorithm only" performance separate from the device's operation, nor is there a "human-in-the-loop" component in terms of interpretive diagnostic assistance that would typically be evaluated for AI. Clinical testing would assess the device's accuracy in measuring temperature.

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

The document does not explicitly state the "type of ground truth" used for the clinical testing. For a thermometer, the ground truth would typically be a highly accurate reference thermometer measurement (e.g., rectal or oral core temperature by an established medical-grade thermometer) against which the test device's readings are compared.

8. The sample size for the training set

This information is not applicable/provided. Thermometers typically do not have a "training set" in the machine learning sense. Their performance is based on their physical sensing and processing mechanisms, calibrated during manufacturing and verified through testing.

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

This information is not applicable/provided for the reasons stated above for item 8.

Summary of available information regarding performance and studies:

Device Performance Claims: The device "conforms to applicable standards included ASTM E1965-98, IEC 60601-1 and IEC 60601-1-2 requirements." This implies that it meets the accuracy and safety specifications within these standards, but specific numerical performance values are not given in this summary.
Study Type: The document states that "bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness." This indicates that both laboratory (bench) and human (clinical) testing were performed to support substantial equivalence.
Purpose of Studies: The studies were conducted to demonstrate that the AVITA TS8/TS9 IR Ear/Forehead Thermometer is substantially equivalent to its predicate devices, AVITA TS2/TS4 Infrared Ear Thermometer (K010462) and Exergen TemporalScanner Thermometer (K011291). The goal was to prove that its technological characteristics do not introduce new questions of safety or effectiveness compared to these legally marketed devices.

In conclusion, this 510(k) summary provides a high-level overview of regulatory compliance and substantial equivalence, but it lacks the granular details of a detailed clinical study report, particularly concerning quantitative performance, specifics of the test population, expert ground truth establishment, and detailed statistical analysis often found in studies for AI/CAD devices.

Summary

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

Attachment F

K03 1503

510(K) SUMMARY

OCT 2 4 2003

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

1.0	Submitter's Name:	AVITA Corp
	Address:	9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County, Taiwan, R.O.C.
	Phone:	001-886-2-85121568
	Fax:	001-886-2-85121347
	Contact:	Mr. Geo Lin, General Manager
2.0	Device Name:	AVITA TS8/TS9 Series IR Ear/ Forehead ThermometerModel no.:TS-802 3 in 1 Ear/ Forehead/Room Thermometer for the TS8 Series ,TS-902 2 in 1 Ear/ Forehead Thermometer for the TS9 Series.
3.0	Classification:	Class II
4.0	Predicate Device:	AVITA TS8/TS9 IR Ear/ Forehead Thermometer has similar general design with►AVITA TS2(Piccolo)/TS4(Exato) Infrared Ear Thermometer (K010462)► Exergen TemporalScanner Thermometer(K011291)
5.0	Device Description:	AVITA TS8/TS9 IR Ear/ Forehead Thermometer is a hand-held, non-sterile, reusable, battery operated device that can measures human body temperature in 2 ways(1) the temporal artery over forehead..(2) Tympanic Temperature via the human ear.Operation is based on the measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear Tympanic .
6.0	Intended Use:	The device is intended for the intermittent measurement and monitoring of human body temperature, by consumers in the home.
7.0	Performance Summary:	In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included ASTM E1965-98, IEC 60601-1 and IEC 60601-1-2 requirements

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

ບບການເພວ່າປານ. い。 ;

The AViTA TS8/TS9 IR Earl Forehead Thermometer have the same intended use and similar technological characteristics as the AViTA TS2(Piccolo)/TS4(Exato) Infrared Ear Thermometer (K010462) Marketed By AViTA Corp. and Exergen TemporalScanner Thermometer(K011291) marketed by Exergen Corporation. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AVITA TS8/TS9 IR Earl Forehead Thermometer is substantially equivalent to the predicate devices.

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

Image /page/2/Picture/1 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 figure with three wavy lines forming its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2003

AVITA Corporation C/O Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail, Flaggstaff, Arizona 86001, U.S.A.

Re: K031503

Trade/Device Name: AViTA TS8/TS9 Series IR Ear/ Forehead Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 23, 2003 Received: September 29, 2003

Dear Ms. Reich:

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.

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

Page 2 - Ms. Reich

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 (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 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,

Siver Runaa

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}------------------------------------------------

NUMBER (IF KNOWN): ___________________________________________________________________________________________________________________________________________________________ 510 (k)

AVITA TS8/TS9 IR Ear/ Forehead Thermometer DEVICE NAME: AVITA Corp.

INDICATIONS FOR USE:

The device is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Patria Cuicente

510(k) Number: K031563

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ V (Optional Format)

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.