The AG Thermographic Camera(Model no.: ATIR M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

Device Description

The AG Thermographic Camera (Model no.: ATIR-M301) consists of an infrared camera, accessories, and PC visualization/analysis software. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image.

AI/ML Overview

This document describes the AG Thermographic Camera, Model no.: ATIR-M301, a telethermographic system.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The document lists performance tests conducted, implying these serve as acceptance criteria. The specific numerical acceptance criteria values are largely absent, except for temperature accuracy.

Acceptance Criteria (Implied)	Reported Device Performance
Temperature Accuracy	< ±1°C
Environment Temperature Factor Test	Conducted (Pass/Fail not explicitly stated, assumed to pass)
Focus Test	Conducted (Pass/Fail not explicitly stated, assumed to pass)
Distanced Object Temperature Test	Conducted (Pass/Fail not explicitly stated, assumed to pass)
Thermal Image Handling	Conducted (Pass/Fail not explicitly stated, assumed to pass)
Small Area Temperature Statistics	Conducted (Pass/Fail not explicitly stated, assumed to pass)
Two-Area Comparison	Conducted (Pass/Fail not explicitly stated, assumed to pass)
Patient History Record Handling	Conducted (Pass/Fail not explicitly stated, assumed to pass)
Electrical Safety	Meets EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC 60601-1-2)

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

The document does not explicitly state the sample size used for any of the performance tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the data). Given the device's nature (a thermal camera), the performance tests likely involved physical measurements rather than patient data.

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)

The document does not mention the use of experts to establish ground truth for the test set. The performance tests described (e.g., temperature accuracy, focus test) are technical validations of the device's functionality, which typically rely on calibrated reference standards and engineering measurements rather than expert clinical interpretation.

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

The document does not describe any adjudication method. This is consistent with the nature of the described performance tests, which are objective engineering measurements rather than subjective interpretations requiring adjudication.

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

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a standalone imaging system, not an AI-assisted diagnostic tool for human readers in the context of comparative effectiveness for clinical interpretations.

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

Yes, the performance tests described are for the standalone device (algorithm for displaying thermal patterns and temperature measurements). The document states, "Performance tests including · Temperature accuracy • Environment temperature factor test · Focus test · Distanced object temperature test · Thermal image handling · Small area temperature statistics and two-area comparison · Patient history record handling were conducted to ensure the device can work as the intended performance." These tests evaluate the device's inherent capability to perform its functions without human interpretation as part of the performance metric.

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

For the performance tests, the ground truth would be established by calibrated reference standards and physical measurements. For example, for "Temperature accuracy," the ground truth would be from a precisely known and stable temperature source measured by a highly accurate reference thermometer. For "Focus test," it would be based on objective image quality metrics. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these device performance validations.

8. The sample size for the training set

The document does not mention any training set or machine learning components. This device is described as employing "passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image." It's a sensor system with display and analysis software, not a machine learning model that requires a training set.

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

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

Summary

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510(K) SUMMARY

1 :: :

K101641

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

JUN 1 6 2011

REV.【C】

1. Submitter's Name:	AG Digital Technology Corp.
Address:	11F, No.15, Sec.1, Chi-Nan Road Taipei, TAIWAN (CHINA)
	10051
Phone:	+886-2- 23575809
Fax:	+886-2-23575845
Contact:	Mr. Telvin Ju / Genral Manager
2. Device Name :
Trade Name:	AG Thermographic Camera,
	Model no.: ATIR-M301
Common Name:	Telethermographic system
Classification name	Telethermographic system (adjunctive use)
3. DEVICE CLASS	The AG Thermographic Camera (Model no.:
	ATIR-M301) has been classified as
	Regulatory Class: I
	Product Code: LHQ
	Regulation Number: 21 CFR 884.2980
4. Predicate Device:	The predicate device is the
	TELETHERMOGRAPHIC CAMERA , Model No. SERIES
	A, E, S AND P (K033967) marketed by FLIR SYSTEMS
	TELESIS DIGITAL INFRARED THERMAL IMAGE
	SYSTEM , Model No. SPECTRUM 9000MB (K020783)
	marketed by TELESIS TECHNOLOGIES INC.
Intended Use:	The AG Thermographic Camera (Model no.: ATIR
	Product: AG Thermographic Camera (Model no.: ATIR-M301)

Section 4 - 510(k) Summary

Page 1 of 5

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M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

6. Device Description: The AG Thermographic Camera (Model no.:

ATIR-M301) consists of an infrared camera, accessories, and PC visualization/analysis software. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, nursing homes, clinics, homes, public areas such as airports, and any environment where healthcare is provided by a healthcare professional.

7. Comparison to 510(k) Predicate Devices

The AG Thermographic Camera (Model no.: ATIR-M301) have the same intended use, principles of operation, and similar technological characteristics વડ predicate devices. Please find Technological Characteristics as follows

Item	AG DigitalATIR-M301	FLIR A20M	TELESISSPECTRUM9000MB
Technology	FPA uncooledMircrobolometer	FPA uncooledMircrobolometer	FPA uncooledMircrobolometer
Material	AmorphousSilicon	AmorphousSilicon	VOx
SpectralResponse	8 ~ 14um	7.5 ~ 13 um	7 ~ 14 um
ArrayResolution	320x240	160x120	320x240
ThermalSensitivity	< 0.1 °C	0.09~0.12°C	0.07°C
Optics	50mm F=0.7FOV= 18.1°(H)×13.7°(V)	F=1.2FOV= 24°(H)×18°(V)	50mm F=0.83FOV=18.7°(H)×14°(V)
Focus	Electric motordriving 0.5M -∞	Manual, 0.3M - ∞	Manual, 0.6M - ∞
SpatialResolution	≤ 1 mrad	2.7mrad	1 mrad
TemperatureRange	30°C ~40°C	-20-+250 °C(-4-+482 °F)	10°C to 40°C
TemperatureResolution	0.1°C	0.1°C	0.1°C
Accuracy	< ±1°C	± 2 °C or ± 2 %of reading	-
Refresh Rate	30 Frames/sec	60 Frames/sec	60 Frames/sec
Workingtemperature	20 - 26°C	-15°C ~ 50°C	18°C~28°C
OperatingTemperature	24°C ± 2°C	-15°C ~ 50°C	20-22.2°C
Data Output	USB2.0	RS-232,IEEE-1394,TCP/IP	RS-170
Dataprocessing	personalcomputer	Camera andpersonalcompute	personalcompute
Display	GUI on PC	GUI on PC	GUI on PC
Userinterface	Software on PC	Software on PC	Software on PC
Power Supply	AC adapter110/240VAC,50/60Hz	AC adapter110/220VAC,50/60Hz	115~~230 VAC50~~60 Hz
Weight	1.3 Kgs	1.7 LB	3 LB

Product: AG Thermographic Camera (Model no.: ATIR-M301) Section 4 - 510(k) Summary REV.【C】 Page 2 of 5

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Product: AG Thermographic Camera (Model no.: ATIR-M301) Section 4 – 510(k) Summary Page 3 of 5 REV.【C】

ﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

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1. Substantial Equivalence Discussion
  AG Thermographic Camera (Model no.: ATIR-M301) has the same general design with the predicate devices

Since the Applicant has selected Legally Marketed Devices

TELETHERMOGRAPHIC CAMERA , Model No. SERIES . ● A, E, S AND P (K033967) marketed by FLIR SYSTEMS
TELESIS DIGITAL INFRARED THERMAL IMAGE ● SYSTEM , Model No. SPECTRUM 9000MB (K020783) marketed by TELESIS TECHNOLOGIES INC.

The has the following similarities to the predicate devices in:

· having the same intended use.
· using similar operating principle..
using similar technological characteristics

In summary, the AG Thermographic Camera (Model no.: ATIR-M301) described in this submission are, in our opinion, substantially equivalent to the predicate devices.

9. Performance AG Thermographic Camera (Model no.: ATIR-M301) meets EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC Data 60601-1-2), and Performance tests including · Temperature accuracy • Environment temperature factor test · Focus test · Distanced object temperature test · Thermal image handling · Small area temperature statistics and two-area comparison

· Patient history record handling
Product: AG Thermographic Camera (Model no.: ATIR-M301) Page 4 of 5 Section 4 - 510(k) Summary REV. [C)

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10. Safety and

Effectiveness

ATIR-M301) meet electrical Safety standard such as EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC 60601-1-2). so it is safe for human body. Additionally, Performance tests including

· Temperature accuracy
Environment temperature factor test

The AG Thermographic Camera (Model no .:

Focus test
Distanced object temperature test
· Thermal image handling
· Small area temperature statistics and two-area comparison
· Patient history record handling

were conducted to ensure the device can work as the intended performance.

Therefore, the device is of safety and effectiveness.

Conclusion

AG Thermographic Camera (Model no.: ATIR-M301) have the same intended use, principles of operation, and similar technological characteristics as predicate devices. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the AG Thermographic Camera (Model no.: ATIR-M301) are substantially equivalent to the predicate devices.

Product: AG Thermographic Camera (Model no.: ATIR-M301) Section 4 - 510(k) Summary REV.【C】 Page 5 of 5

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.

Public Health Service

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

AG Digital Technology Corp. % Ms. Jennifer Reich Senior Consultant Harvest Consulting Corp. 2904 N. Boldt Drive FLAGSTAFF AZ 86001

JUN 1 6 201

Re: K101641

Trade/Device Name: AG Thermographic Cmaera, Model no: ATIR-M301 Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: January 26, 2011 Received: January 7, 2011

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 class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K101641

Device Name: AG Thermographic Camera, Model no.: ATIR-M301 AG Digital Technology Corp.

Indications For Use:

Prescription Use AND/OR ﺳﮯ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

Michael D'Orazio
(Division Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101 641

Regulation Number and Section

§ 884.2980 Telethermographic system.

(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.