SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for themally significant indications in the breast region. The significance of the value of these thermal patterns is determined by profession. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

Device Description

The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.

SMILE-100 System consists of the following:

An off-the-shelf FDA cleared thermal camera with its associated camera control software (i) provided by the thermal camera vendor for capturing and viewing thermal images
An off the shelf laptop/desktop computer system with display, keyboard and mouse. (ii)
SMILE-100 Software for viewing thermal patterns in thermal images (iii)

The SMILE-100 Software takes thermal images captured using off-the-shelf FDA-cleared thermal camera and provides various visualization options in multiple customizable views/palettes and also generates a report with quantitative thermal parameters and annotated images. The Software supports two user roles (i) a thermographer or imaging technician role and (ii) Expert thermologist role. The imaging technician captures thermal images and uploads them to the cloud-hosted SMILE-100 Software which performs image quality checks and submits to Expert. The Expert can select a temperature threshold for the SMILE-100 Software to highlight areas with thermal activity above the threshold in thermal images. The software makes no estimation of the thermal threshold. The software makes no determination regarding what the thermal patterns or relative temperature values mean. Expert thermologist needs to infer the meaning of high thermal activity and other areas of interest based on his/her visual interpretation of those patterns and thermal values.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SMILE-100 System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a quantitative manner for the SMILE-100 software's diagnostic performance or a clinical study proving its effectiveness in identifying thermally significant indications. The performance testing section primarily focuses on technical verification and comparison with a predicate device's technological characteristics.

However, based on the provided comparison tables, we can infer some technical performance characteristics that are critical for equivalence with the predicate device.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (SMILE-100 System)
Thermal Camera Characteristics:
Detector Type: FPA, uncooled Microbolometer	FPA, uncooled Microbolometer
Thermal sensitivity: < 50 mK	< 50 mK
Accuracy: ±2°C or ±2% of reading	±2°C or ±2% of reading
IR Resolution: Minimum 320 × 240 pixels	Minimum 320 × 240 pixels
Field of view: 25°×18.8°	25°×18.8°
Emissivity: from 0.01 to 1.0	from 0.01 to 1.0
System Characteristics:
Display Device: Laptop	Laptop
Record thermal images to hard disk: Yes	Yes
Manual marking of regions that have high thermal activity: Yes	Yes
Temperature value display for every pixel: Yes	Yes

Note: The document explicitly states: "The software makes no determination regarding what the thermal patterns or relative temperature values mean. Expert thermologist needs to infer the meaning of high thermal activity and other areas of interest based on his/her visual interpretation of those patterns and thermal values." This indicates that the device's technical performance is about accurate capture and display of thermal data, and the diagnostic interpretation remains with the human expert. Therefore, a clinical performance study with sensitivity/specificity metrics for disease detection is not presented for the software itself.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not detail a specific test set sample size or data provenance (country of origin, retrospective/prospective) for a clinical performance study of the SMILE-100 software's diagnostic capabilities.

The "Performance Testing" section mentions:

"Verification during Product Development"
"Verification of SMILE-100 System Output Parameters"
"Interoperability Testing with different Thermal Camera Models"
"Comparison of the equivalence of temperature values between thermal camera and SMILE-100 Software"

These are technical verification activities, not a clinical performance study involving patient data for diagnostic accuracy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As there is no clinical performance study on a test set mentioned in the document, there is no information about experts used for establishing ground truth. The device relies on the interpretation of an "Expert thermologist."

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The SMILE-100 software provides visualization and quantitative parameters, but the "Expert thermologist" is still responsible for interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. The document explicitly states: "The software makes no determination regarding what the thermal patterns or relative temperature values mean... Expert thermologist needs to infer the meaning of high thermal activity and other areas of interest based on his/her visual interpretation of those patterns and thermal values." This confirms that the device is not intended for standalone diagnostic performance. It is an "adjunctive diagnostic imaging" tool.

7. The Type of Ground Truth Used

Not applicable. Since no clinical performance study evaluating diagnostic accuracy is presented, there is no ground truth type (pathology, outcomes data, expert consensus, etc.) mentioned in relation to the SMILE-100 software's performance as a diagnostic aid.

8. The Sample Size for the Training Set

Not mentioned. The document does not provide details on a training set size, as it focuses on technical verification and equivalence rather than a machine learning model's diagnostic performance for which training data would be required.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned. Similar to point 8, with no training set data or a clinical performance study described, the method for establishing ground truth for a training set is not provided.

Summary

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Niramai Health Analytix Private Limited % Yolanda Smith Consultant Smith Associates 1468 Harvell Avenue CROFTON MD 21114

Re: K212965

Trade/Device Name: Smile-100 System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic System Regulatory Class: Class I, reserved Product Code: LHQ Dated: January 31, 2022 Received: February 2, 2022

Dear Yolanda Smith:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

March 10, 2022

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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) K212965

Device Name SMILE-100 System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary — K212965

5.1 Submitter

Niramai Health Analytix Private Limited, Innova Pearl, Ground Floor, No. 17, 5th Block, Koramangala Industrial Layout, Koramangala, Bangalore - 560095, Karnataka, India

Contact Person: Dr. Geetha Manjunath Email id: contact@niramai.com

Date Prepared: 9 March 2022

5.2 Device Details

Trade Name	SMILE-100 System
Common or Usual Name	Telethermographic System
Classification Name	System, Telethermographic (Adjunctive Use)
Regulation Number	21 C.F.R. 884.2980
Device Class	Class I
Product Code	LHQ

5.3 Predicate Device Details

Product Name	Med-Hot Thermal Imaging System
Manufacturer	Med-Hot Thermal Imaging, Inc.
510(k) Number	K171928

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5.4 Device Description

SMILE-100 System consists of the following:

An off-the-shelf FDA cleared thermal camera with its associated camera control software (i) provided by the thermal camera vendor for capturing and viewing thermal images
An off the shelf laptop/desktop computer system with display, keyboard and mouse. (ii)
SMILE-100 Software for viewing thermal patterns in thermal images (iii)

5.5 Indications for Use

SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region. The significance of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

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Table 1: Indications for Use Statement Comparison
SMILE-100 System	Predicate Device	Comment
SMILE-100 System is intendedto review, measure and recordskin temperature patterns andvariations emitted from thehuman body. It is intended foruse as adjunctive diagnosticimaging for thermally significantindications in the breast region.The significance of the value ofthese thermal patterns isdetermined by professionalinvestigation. This device isintended for use by qualifiedhealthcare personnel trained inits use. The system is notintended for absolutetemperature measurements.The system is not intended tobe used as a thermometrydevice.	The Med-Hot Thermal ImagingSystems are intended to review,measure and record skintemperature patterns andvariations emitted from thehuman body. They are intendedfor use as adjunctive diagnosticimaging for thermally significantindications in the regions of thehead and neck, breast, chest,abdomen, back and extremities.The significance of the value ofthese thermal patterns isdetermined by professionalinvestigation. This device isintended for use by qualifiedtechnical personnel trained in itsuse.	DifferentThe indications for use ofboth devices are the sameexcept that the SMILE-100System covers oneanatomical site (breast)while the Predicate Devicesupports breast and otherparts of the body.

5.6 Comparison of SMILE-100 System with the Predicate Device

Table 2: Predicate Product Comparison of Regulatory Parameters
Parameters	SMILE-100 System	Med-Hot Thermal ImagingSystems	Equivalence
Product code	LHQ	LHQ	Same
Regulation No.	21 CFR 884.2980	21 CFR 884.2980	Same
Classification	Class I	Class I	Same

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Regulation Name	Telethermographic System	Telethermographic System	Same
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Table 3: Comparison of Technological characteristics
Parameters	SMILE-100 System	Predicate Device	Equivalence
Principle ofoperation	Telethermography	Telethermography	Same
Method ofDataCollection	Non-contact measurementof passiveinfrared emissions	Non-contact measurementof passiveinfrared emissions	Same
TemperatureMeasuringinstrument	An infrared camera.FLIR A315, FLIR A310, FLIRE75, FLIR E76, FLIR Axxxseries, FLIR Exx series (RefK033967),Spectron IR's TyTron C-500IR (Ref K032471),Infrared Cameras Inc.'s9640P (Ref K073581)	An infrared camera.MAX 076 (FLIR A325sc) orMAX 307 (FLIR A655sc)	SimilarBoth devices use infraredcameras as thetemperature measuringinstruments. Though thecamera model numbers aredifferent, they haveequivalent specifications(detailed below)
Table 3.a Technological Characteristics of Infrared/Thermal Camera
Detector Type	Focal Plane Array (FPA),uncooled Microbolometer	FPA, UncooledMicrobolometer	Same
Thermalsensitivity	< 50 mK	< 50 mK	Same
Accuracy	±2°C or ±2% of reading	±2°C or ±2% of reading	Same
IR Resolution	Minimum 320 × 240 pixels	320 × 240 pixels	Same
Field of view	25°×18.8°	25°×18.8°	Same
Emissivity	from 0.01 to 1.0	from 0.01 to 1.0	Same

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Table 3.b Technological Characteristics of the System
Display Device	Laptop	Laptop	Same
Record thermalimages to harddisk	Yes	Yes	Same
Infrastructurefor analysis anddata storage	Secure cloud server	Hard Disk	Different
Thermal ImageVisualizationSoftware Used	SMILE-100 Software	MedHot TotalVisionSoftware	The two software's havesimilar characteristics asdetailed in Table 3.cbelow
Table 3.c Technological Characteristics of Thermal Image Visualization Software
Manual markingof regions thathave highthermal activity	Yes	Yes	Similar
Input imagequality check	Yes	No	Different
Temperaturevalue display forevery pixel	Yes	Yes	Same
Support for role-based accesscontrol	Yes	No	Different
ThermalParametersgenerated in theoutput	Yes	Yes	Additional thermalparameters shown.
Compatibilitywith standardimaging format(DICOM)	Yes	No	Different

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5.7 Performance Testing

The overall verification activities performed for SMILE-100 Software includes the following:

Verification during Product Development
Verification of SMILE-100 System Output Parameters
. Interoperability Testing with different Thermal Camera Models
Comparison of the equivalence of temperature values between thermal camera and . SMILE-100 Software

The following standards were followed-in the development of the SMILE-100 System:

ISO 14971: 2019 Medical Devices Application of Risk Management to Medical Devices .
. IEC 62304: 2015 Medical Device Software - Software Life Cycle Processes

5.8 Conclusion

The SMILE-100 System is a breast thermography device with a visualization tool. The SMILE-100 System is only an adjunctive diagnostic imaging modality. From the discussion above, it is determined that SMILE-100 System is substantially equivalent to the Predicate Device, and there are no new concerns of safety and efficacy. The device has also been described and tested to prove the same.

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.