The FIRSTSense Breast Exam® device is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel. It is intended for use in adult patient populations. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

Device Description

The FirstSense Breast Exam® system consists of a portable device (FSBE Tester) that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact during a screening test. The device emits no radiation to the patient. The device consists of a thermal camera, a 3D camera, a tester main body consisting of metal and plastic to safely and securely house the electronic and mechanical components and motors (to adjust cameras for various sized patients), a computer, software components and two color monitors, as well as an air cooling unit that blows cool air during part of the screening test cycle. The FSBE system also contains a cloud server for safe storage of test data. During a screening test, the FSBE Tester's thermal camera acquires thermal images, and the 3D camera acquires depth data and visible light images of the patient breasts. When a test is completed, the acquired data is uploaded to the FSBE system's cloud server, the FSM Central Server. The uploaded data becomes available to a physician when the FirstSense Data Viewer (FSDV) application downloads the data from the server to a local computer. The FSDV application allows the physician to view the thermal images, the 3D depth image and visible RGB images of the patient breasts. The depth and visible images are provided to the physician as additional information about the breasts with no quantitative data. When the FSDV application provides the thermal images, it allows the application user to select breast regions (nipple, areola, whole breast quadrants) and regions of interest on the thermal views. The FSDV application provides temperature differential data between the left and right breast regions, and temperature differential data for the regions of interest before and after blowing cool air to the breasts in Test Summary report. The FSDV allows the application user to enter threshold values to be compared to the calculated temperature differential data. The FSDV provides comments in the Test Summary Report to indicate that the temperature differential data is within or above the entered threshold value. The FSDV does not include default threshold values and does not provide comments in the Test Summary report should the user choose not to enter threshold values.

AI/ML Overview

The provided document is a 510(k) summary for the FIRSTSense Breast Exam® device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, ground truth details, and training set information) is not explicitly present in the provided text. The document details performance validation tests for the device's components and software, but not a study proving its diagnostic efficacy against specific clinical acceptance criteria.

Missing Information:

A table of acceptance criteria and reported device performance related to diagnostic accuracy.
Sample sizes used for a "test set" in the context of diagnostic performance.
Data provenance (country of origin, retrospective/prospective) for a diagnostic performance study.
Number and qualifications of experts for establishing ground truth.
Adjudication method for a test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or details on the effect size of AI assistance.
Details on a standalone (algorithm only) performance study.
The type of ground truth used for diagnostic performance (e.g., pathology, outcomes data).
Sample size for a training set (as this is a 510(k) for a thermal imaging system, not an AI software where a training set size would be explicitly discussed here).
How ground truth for a training set was established.

Information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:
The document does not provide acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity for breast cancer detection). Instead, it lists various engineering and functional validation tests for the device's components. Since there are no specific diagnostic acceptance criteria stated, there is no corresponding reported performance in that context. The document broadly states that "In all instances, the FIRSTSense Breast Exam® functioned as intended and the results observed and reported were as expected," for the technical performance tests.

Below is a summary of the technical performance validations mentioned:

Acceptance Criteria (Implied - passed functional tests)	Reported Device Performance
Safety and Electrical Compatibility
IEC 60601-1-1 (Basic safety & essential performance)	Tested for compatibility
IEC 60601-1-2 (Electromagnetic compatibility)	Tested for compatibility
Mechanical Component Performance
Full device validation (pre-check routine)	Validated
Software functional verification tests	Performance verified
Software Functionality
FSDAQ software pre-check routine	Verified
FSDAQ device log	Verified
FSDAQ test sequence and error management	Verified
FSDAQ data storage and upload	Verified
FSDAQ patient positioning	Verified
Thermal Camera Performance
Thermal Camera Uniformity Test	Executed
Thermal Camera Drift Test	Executed
Thermal Camera Calibration Verification and Bias Test	Executed
Thermal Camera Consistency Test	Executed
Thermal Camera Sensitivity Test	Executed
BBR Accuracy and Uniformity Test	Executed

2. Sample sized used for the test set and the data provenance: Not mentioned as the document describes technical validation tests, not a clinical diagnostic performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. Technical validation tests do not typically use expert ground truth in this manner.

4. Adjudication method for the test set: Not applicable/not mentioned.

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: Not mentioned. The device is a "Telethermographic System," and the document describes its hardware and software functionality, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study with AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed diagnostic performance studies with such ground truth are not presented. The "ground truth" for the technical tests would be the expected functional output or measured physical parameters.

8. The sample size for the training set: Not mentioned. This type of submission is for a medical device that captures images and provides temperature differentials, not an AI/ML diagnostic algorithm that would have a distinct training set.

9. How the ground truth for the training set was established: Not mentioned. (See point 8).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

June 1, 2016

First Sense Medical, LLC % John J. Smith, MD, JD Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004

Re: K160573

Trade/Device Name: FirstSense Breast Exam Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: May 11, 2016 Received: May 11, 2016

Dear Dr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K160573

Device Name

FIRSTSense Breast Exam®

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

First Sense Medical, LLC's FIRSTSense Breast Exam®

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

First Sense Medical, LLC 2001 Centerpoint Parkway, Suite 110 Pontiac, MI 48341 Phone: 770-617-9416 Facsimile: 248-876-9278

Contact Person: Alan Klevens

Date Prepared: May 11, 2016

Name of Device and Name/Address of Sponsor

FIRSTSense Breast Exam®

First Sense Medical, LLC 2001 Centerpoint Parkway, Suite 110 Pontiac, MI 48341

Common/Classification Name

Telethermographic System (Adjunctive Use) (Product Code: LHQ; 21 C.F.R. 884.2980)

Predicate Device

Infrared Sciences Corp., BreastScan IR (K032350)

Intended Use / Indications for Use

Device Description/Technological Characteristics

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data is uploaded to the FSBE system's cloud server, the FSM Central Server. The uploaded data becomes available to a physician when the FirstSense Data Viewer (FSDV) application downloads the data from the server to a local computer. The FSDV application allows the physician to view the thermal images, the 3D depth image and visible RGB images of the patient breasts. The depth and visible images are provided to the physician as additional information about the breasts with no quantitative data. When the FSDV application provides the thermal images, it allows the application user to select breast regions (nipple, areola, whole breast quadrants) and regions of interest on the thermal views. The FSDV application provides temperature differential data between the left and right breast regions, and temperature differential data for the regions of interest before and after blowing cool air to the breasts in Test Summary report. The FSDV allows the application user to enter threshold values to be compared to the calculated temperature differential data. The FSDV provides comments in the Test Summary Report to indicate that the temperature differential data is within or above the entered threshold value. The FSDV does not include default threshold values and does not provide comments in the Test Summary report should the user choose not to enter threshold values.

Performance Data

The device performance was validated by conducting the following tests:

-The FSBE Tester was tested for its compatibility with both IEC 60601-1-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance collateral standard: Electromagnetic compatibility.
-The FSBE Tester's mechanical parts and their expected performance are validated during full device validation. specifically during the verification of the device's pre-check routine which checks each device hardware component and its expected functionality. Also during execution of software functional verification tests, the performance of individual mechanical components are verified.

The following verification tests were executed for full device validation:

FSDAQ software pre-check routine test verifies the pre-check routine and integrity O of device hardware components.
FSDAQ device log test verifies the device log and software ability to record events O related to test sequence and hardware status.
FSDAQ test sequence and error manaqement verifies the software for manaqing a o test sequence and managing the errors, as well as verifies device hardware performance during the test sequence.
FSDAQ data storage and data upload verifies software functionality for temporary O test data storage and test data upload to the server.
FSDAQ patient positioning verifies the software functionality to provide assistance O to the operator to position the device before the test sequence. Also verifies the hardware components such as the 3D camera and its performance during patient positioning.
-The thermal camera performance is validated by executing the following thermal camera performance verification tests to evaluate the respective characteristics of the thermal camera:
- Thermal Camera Uniformity Test; o
- Thermal Camera Drift Test; O
- Thermal Camera Calibration Verification and Bias Test; O

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Thermal Camera Consistency Test; O
Thermal Camera Sensitivity Test; o
o BBR Accuracy and Uniformity Test.

The above listed tests summarize the performance and the validation and verification activities conducted for the thermal camera, FSM Black Body Radiator, system performance, software and the device functionality. This testing demonstrates that the device meets all FIRSTSense Breast Exam® requirements and specifications. In all instances, the FIRSTSense Breast Exam® functioned as intended and the results observed and reported were as expected.

Substantial Equivalence

The FIRSTSense Breast Exam® has the same intended uses and indications, as well as similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the FIRSTSense Breast Exam and its predicate device raise no new issues of safety or effectiveness. Thus, the FIRSTSense Breast Exam® is substantially equivalent.

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A comparison table outlining similarities and differences of the predicate device is provided below:

#	Feature	BreastScan IR ™ (Predicate Device)K032350	FIRSTSense Breast Exam®(Subject Device)	Comments
1	Intended Use	The Infrared Sciences BreastScanIR™ System is intended for viewingand recording heat patternsgenerated by the human body in thehospital, acute care settings,outpatient surgery, healthcarepractitioner facilities or in anenvironment where patient care isprovided by qualified healthcarepersonnel. The patient populationsinclude adult. The device is foradjunctive diagnostic screening fordetection of breast cancer anddiseases affecting blood perfusion orreperfusion of tissue or organs. Thisdevice is intended for use by qualifiedhealthcare personnel trained in itsuse.	The FirstSense Breast Exam®system is intended for viewing andrecording heat patterns generated bythe human body in the hospital, acutecare settings, outpatient surgery,healthcare practitioner facilities or inan environment where patient care isprovided by qualified healthcarepersonnel. The patient populationsinclude adult. The device is foradjunctive diagnostic screening fordetection of breast cancer anddiseases affecting blood perfusion orreperfusion of tissue or organs. Thisdevice is intended for use by qualifiedhealthcare personnel trained in itsuse.	Same
2	Method of datacollection	Non-contact passive infraredemissions	Non-contact passive infraredemissions	Same
3	Data processing	CPU with custom algorithms	CPU with custom algorithms	Same
#	Feature	BreastScan IR™ (Predicate Device)K032350	FIRSTSense Breast Exam®(Subject Device)	Comments
4	Collectioninstrument	Infrared camera	Infrared camera, 3D camera	Substantially SimilarThe FSBE system uses a 3Dcamera. The FSBE systemincludes a 3D camera for properpatient positioning and acquiringdepth and visible image dataduring the screening test. The 3Dcamera helps the operator assurepatient positioning before the testby providing a live patient image.The depth data and the visibleimage data is presented to theuser as additional information(reference). The depth data andthe visible image data does notprovide any quantitativeinformation. This minor differenceraises no new safety oreffectiveness concerns because ofthe above described reasons.
5	Measurementparameters	Allows for measurement of thermalemissions	Allows for measurement of thermalemissions	Same
#	Feature	BreastScan IR TM (Predicate Device)K032350	FIRSTSense Breast Exam®(Subject Device)	Comments
6	Storage	Hard disk	Hard disk and cloud server	Substantially SimilarThe predicate device uses a localhard drive for its data storage.The FSBE system uses a cloudserver to assure long-term safeand secure storage of data. Thedata transferred to the cloud doesnot contain any personallyidentifiable patient information.The data transferred to the cloudonly contains data acquired duringthe screening test. The datatransfer occurs using an industryand government standard anddigitally signed cryptographiccertificates. This minor differenceraises no new safety oreffectiveness concerns because allinformation is encrypted, stored,backed up and maintained by aprofessional service.
7	Detector type	Focal plane array	Focal plane array	Same
8	Detectorresolution	320 × 240 Pixels	320 × 240 Pixels	Same
#	Feature	BreastScan IR™ (Predicate Device)	FIRSTSense Breast Exam® (Subject Device)	Comments
		K032350
9	Thermal sensitivity	80 mK	50 mK	Substantially SimilarThe FSBE uses a thermal camera with a manufacturer-specified sensitivity of 50mK; this is slightly more sensitive than the 80mK specified by the BreastScan IR™. This minor difference in sensitivity of the thermal camera raises no new safety or effectiveness concerns as the camera has been validated as part of the subject system and meets all performance requirements.
10	Cooling device	Air conditioning unit	Air conditioning unit	Same
11	Camera output	14 bit digital	14 bit digital	Same
12	User Interface	A monitor is provided to view thermal images during the test. A keyboard and mouse is provided to the operator to enter the patient ID and start a test.	Two touchscreen monitors are provided (operator and patient) to view the thermal images during the test. A keyboard and mouse is provided to the operator to enter the patient ID and start a test.	Substantially Similar
#	Feature	BreastScan IR™ (Predicate Device)K032350	FIRSTSense Breast Exam®(Subject Device)	Comments
13	Result Reporting	BreastScan IR software allows theuser to select breast regions (nipple,areola, whole breast, breastquadrants) and regions of interest(ROI). BreastScan IR provides thethermal views, and temperaturedifferentials for the selected breastregions and ROIs. BreastScan IRprovides report printing capability.	FirstSense Data Viewer (FSDV)software allows the user to selectbreast regions (nipple, areola, wholebreast, breast quadrants) and regionsof interest (ROI). FSDV provides thethermal views, and temperaturedifferentials for the selected breastregions and ROIs. FSDV providesreport printing capability.	Same

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The subject device has the same intended use and characteristics as the predicate device. Documentation supplied in this submission demonstrates that any difference in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the First Sense Breast Exam® system is substantially equivalent to the predicate device.

Conclusions

FIRSTSense Breast Exam® has the same intended use as the . predicate device, Infrared Sciences BreastScan IR™ System, and therefore it may be found substantially equivalent;
FIRSTSense Breast Exam® and the predicate device have the same ● indication statements;
FIRSTSense Breast Exam® has similar technological characteristics . as the predicate device, Infrared Sciences BreastScan IR™ System
. The subject device's new technological characteristics, such as the usage of a 3D camera to help the operator initially position the thermal camera and acquire visible images and 3D images during the test, do not raise any new questions of safety or effectiveness;
. Accepted scientific methods, i.e., bench tests, demonstrated that the effects of the new characteristics do not raise any new questions of safety and effectiveness. Thus, the subject device is substantially equivalent.

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.