The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for themally significant indications stemming from heat emitted from the human body. The significance of these thermal pariations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.

The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

Device Description

The ThermPix Thermovisual Camera is a Telethermographic system which consists of infrared and visual cameras and a touch-screen display. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via Wifi to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer.

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, clinics, and any environment where is provided by a healthcare professional.

AI/ML Overview

The provided text focuses on the 510(k) summary for the "ThermPix Thermovisual Camera" and its comparison to a predicate device. It details technical specifications and non-clinical testing performed to establish substantial equivalence. However, it explicitly states that clinical testing was not required and therefore does not contain information about a study proving the device meets acceptance criteria related to human performance, ground truth, expert adjudication, or MRMC studies.

I will extract the available information and highlight what is not present based on your request.

Here's the breakdown of the acceptance criteria and the study that was provided (non-clinical):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct "acceptance criteria" but are implied through the comparison with the predicate device and the non-clinical performance testing. The "reported device performance" is the result of these non-clinical tests.

Trait / Performance Metric	Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (ThermPix Thermovisual Camera)
Indications for Use	To view, measure, and record heat patterns and variations as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. Not for sole screening/diagnosis, not a thermometry device.	Views, measures, and records heat patterns and variations. Intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. NOT for sole screening or diagnosis, NOT a thermometry device. (Identical to predicate)
Intended User	Healthcare Professionals	Healthcare Professionals (Identical)
Environment of Use	Clinical Environment	Clinical Environment (Identical)
Detector Type	Uncooled VOx microbolometer	Uncooled VOx microbolometer (Identical)
Spectral Range	Longwave infrared; 7.5 µm to 13.5 µm (Predicate)	Longwave infrared; 7.8 µm to 14 µm (Substantially Equivalent)
Frame Rate	60 Hz (Predicate)	9 Hz and 27 Hz (Substantially Equivalent - lower, but deemed acceptable for the intended use)
Thermal Sensitivity	< 60 mK (Predicate, Consumer grade)	65 mK (typical) (Substantially Equivalent - slightly higher, but deemed acceptable)
Accuracy (Temperature Difference)	+/- 1.1 °C at 99% confidence (Predicate)	+/- 0.68°C at 95% confidence (1.02°C at 99%) with measurement bias within +/-0.1 °C. (Near identical/slightly better performance)
Array Format & Field of View	320 x 256 with 24° FOV (Predicate)	320 x 240 with 56° (H) and 42° (V) FOV (Subject device has a wider FOV allowing closer use, deemed no practical difference)
Temperature Difference Discernibility	Comparable to predicate (1.1℃ at 99% confidence discernibility)	Able to distinguish temperature differences of 1°C with 99% confidence. (Meets comparably to predicate, which has 1.1C accuracy at 99% confidence.)
Safety & Performance Standards	Compliance with IEC 60601-1-2:2014 4th Edition (EMC), IEC 60601-1:2005 Ed. 3+A1 (Basic Safety/Essential Performance), and IEC 62304/FDA Guidance for Medical Device Software.	All listed standards were used in non-clinical testing to support substantial equivalence. (Specific results not detailed beyond compliance statements.)

The study described is non-clinical testing only.

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

Non-Clinical Testing: Relative Temperature Difference (Thermal Sensitivity)
- Sample Size: "image data collected from 2 cameras"
- Data Provenance: Not specified regarding country of origin, but it is laboratory-based data from the manufacturer's testing. It is a prospective test conducted by the manufacturer for the submission.

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

N/A. The provided text explicitly states: "Human Clinical Performance Testing: Clinical testing was not required to demonstrate the safety and effectiveness of the device." Therefore, no human experts were involved in establishing ground truth for clinical performance. The "ground truth" for the non-clinical tests was established using traceable certified reference black body calibrators and thermocouples.

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

N/A. As no clinical testing with human readers/experts was performed, there was no adjudication method.

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. No clinical or MRMC studies were performed or described. The device is a "Thermovisual Camera" and the submission does not describe an AI component that would assist human readers in interpretation.

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

This device is a camera system. Its performance (e.g., accuracy, thermal sensitivity) was tested non-clinically as a standalone device. While there's "proprietary software to display the temperature distribution pattern," the submission doesn't describe an "algorithm" making diagnostic assessments. The output is an image to be interpreted by "qualified technical personnel" requiring "clinical judgement and experience." So, yes, non-clinical standalone performance was assessed (camera system's ability to measure and display thermal patterns), but not in the context of an "algorithm" making diagnostic decisions to be evaluated similar to an AI diagnostic aid.

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

For the non-clinical thermal accuracy and sensitivity tests, the "ground truth" was established by traceable certified reference black body calibrators and thermocouples, which are highly precise and accurate physical measurement standards.

8. The sample size for the training set:

N/A. The provided text does not describe any machine learning/AI component that requires a training set. The device's software appears to be for image display and processing, not for diagnostic interpretation or classification.

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

N/A. As there's no mention of a training set or AI model, this is not applicable.

Summary

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April 12, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

USA Therm, Inc. % Mary Vater 510(k) Consultant Medical Device Academy 345 Lincoln Hill Road SHREWSBURY VT 05738

Re: K213650

Trade/Device Name: ThermPix Thermovisual Camera Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: Class I, reserved Product Code: LHQ Dated: March 3, 2022 Received: March 3, 2022

Dear Mary Vater:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213650

Device Name ThermPix Thermovisual Camera

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY - K213650

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

I. SUBMITTER
USA Therm, Inc.21550 Biscayne Boulevard, Suite 133Aventura, Florida 33180Tel: +1.844.998.4376Fax:
Contact Person:	Ariel Soffer, MD, CEO
Date Prepared:	November 18, 2021
II. DEVICE
Name of Device:	ThermPix Thermovisual Camera
Classification Name:	Telethermographic System
Regulation:	21 CFR §884.2980
Regulatory Class:	Class I
Product Classification Code:	LHQ
III. PREDICATE DEVICE
Predicate Manufacturer:	InTouch Health

Predicate 510(k): K181716

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

Predicate Trade Name:

InTouch Thermal Camera™

V. INDICATIONS FOR USE

The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

	ThermPix ThermovisualCamera	InTouch Thermal Camera(K181716)	Comments onSubstantialEquivalence
Indications for Use	The ThermPixThermovisual Camera isintended to view, measure,and record heat patternsand variations. It isintended for use asadjunctive diagnosticimaging for thermallysignificant indicationsstemming from heatemitted from the humanbody.The significance of thesethermal patterns andvariations is determined byprofessional investigation.This device is intended foruse by qualified technicalpersonnel.Clinical judgement andexperience are required toreview and interpret theinformation transmitted.	The InTouchThermal Camera isintended to view, measureand record heat patternsand variations. It isintended for use asadjunctive diagnosticimaging for thermallysignificant indicationsstemming from heatemitted from the humanbody.The significance of thesethermal patterns andvariations is determined byprofessional investigation.This device is intended foruse by qualified technicalpersonnel trained in its use.Clinical judgment andexperience are required toreview and interpret theinformation transmitted.	Both devices areindicated to view,measure, andrecord heatpatterns andvariations as anadjunctivediagnostic imagingdevice forthermallysignificantindicationsstemming fromheat emitted fromthe human body.The significanceof these thermalpatterns andvariations isdetermined byprofessionalinvestigation.
	The ThermPixThermovisual Camerais only for use in additionto other diagnostic medicaldevices.It does not provide anyabsolute measurement oftemperature and should notbe used for sole screeningor diagnosis for any diseaseor condition. The system isnot intended to be used as athermometry device.	The InTouch ThermalCamerais only for use in additionto other medical devices(i.e. Thermometer,Ultrasound,Mammography).It does not provide anyabsolute measurement oftemperature and should notbe used for sole screeningor diagnosis for any diseaseor condition.	Both devices alsoindicate that theyare not intendedfor absolutetemperaturemeasurement orsole screening.
Intended User	Healthcare Professionals	Healthcare Professionals	Identical
Environment of Use	Clinical Environment	Clinical Environment	Identical
Imaging
Detector Type	Uncooled VOxmicrobolometer	Uncooled VOxmicrobolometer	Identical
Spectral Range	Longwave infrared; 7.8 µm to 14 µm	Longwave infrared; 7.5 µm to 13.5 µm	Substantially Equivalent
Frame Rate	9 Hz and 27 Hz	60 Hz	Substantially Equivalent
Thermal Sensitivity	65 mK (typical)	< 60 mK (Consumer grade)	Substantially Equivalent
Accuracy	+/- 1°C (for temperature difference)	+/- 1.1 °C (for temperature difference)	Substantially Equivalent
Optics
Array Format	320 x 240 with 56° (H) and 42° (V) field of view	320 x 256 with 24° field of view	The subject device has a wider field of view that allows the user to be closer to areas of interest than the predicate, otherwise no practical difference
Electrical
Video Channels	USB-2	USB-2	Identical
Control Channels	USB	USB	Identical
Input Voltage	3.3 VDC to 5 VDC (5V used)	3.3 VDC	Results in no practical performance difference
Power Dissipation	300 mW	Varies by configuration; as low as 500 mW	Lower power consumption than predicate is of no practical difference
Environmental
Operating Temperature Range	-10°C to +60°C (15°C to 24°C recommended for best results)	-40°C to 80°C	Differences due to use of Lithium polymer rechargeable battery that looses capacity at low temperatures. Of no practical consequence because intended use location is in a doctor's office or hospital.
Non-Operating Temperature Range	-40°C to 60°C	-50°C to 105°C
Performance Testing
Temperature Difference Accuracy	The ThermPix Thermovisual Camera temperature difference accuracy was calculated and verified to be +/- 0.68°C at 95% confidence (1.02°C at 99%) with a	The InTouch Thermal Camera temperature difference accuracy was calculated and verified to be +/- 1.1 °C at 99% confidence with a measurement bias within	Near identical:- The accuracy of the subject device is slightly better than predicate
measurement bias within+/-0.1 °C. To determinethese values, data wascollected over multiplecameras, multiple users,and multiple temperaturesranging from 20-40 °C. Atraceable certified referenceblack body calibrator andthermocouples wereemployed in order toestablish the temperaturedifference accuracy andbias, and a GageRepeatability &Reproducibility was run toassess the variation of themeasurement system. Theroot sum of squares methodwas employed to computethe overall uncertainty ofthe system at the givenconfidence interval.	+/-0.1 °C. To determinethese values, data wascollected over multiplecameras, multiple users,and multiple temperaturesranging from 22-48 °C.Traceable certifiedreference black bodycalibrators andthermocouples wereemployed in order toestablish the temperaturedifference accuracy andbias, and a GageRepeatability &Reproducibility was run toassess the variation of themeasurement system. Theroot sum of squares methodwas employed to computethe overall uncertainty ofthe system at the givenconfidence interval.	but thedifference iswithin the +/-0.1 certaintyinterval.- Subject deviceassessmentwas in therange between10-40°C asthis is deemedcloser to thetemperaturesof human skinthan thepredicate's 22-48°C.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

। IEC 60601-1-2:2014 4th Edition Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
| IEC 60601-1:2005 Ed. 3+A1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
Software verification and validation according to IEC 62304 Edition 1.1 2015-06 l Medical device software - Software life cycle processes and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Summary of Accuracy

Relative Temperature Difference (thermal sensitivity)

The ability of the ThermPix Thermovisual System to enable users to distinguish temperature differences of 1°C with a thermal image was tested using image data collected from 2 cameras at temperatures ranging from 20℃ to 40℃ in increments of 2℃. Results indicate that with 99% confidence temperature differences in 1°C or more are discernible by a trained user. The results indicate that the device performance is comparable to that of the proposed 510(k) predicate device K181716 with a reported error of 1.1℃ at the 99% confidence level.

Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

VIII. CONCLUSIONS

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Based on the technology characteristics and non-clinical testing, it is the conclusion of USA Therm, Inc. that the ThermPix Thermovisual Camera is substantially equivalent to the predicate device and raises no new issues of safety.

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.