The PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera.

The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects.

The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring.

The PanopticAl Vital Signs device is not intended to be the sole method to assess a subject's physical health condition. The pulse rate measurements it provides should complement, not replace, professional medical care and/or medication.

Device Description

PanopticAl Vital Signs is a medical software device that uses remote photoplethysmography (rPPG) to measure a person's pulse rate. The app utilizes the surrounding light as the light source and works by capturing and measuring the subtle color changes on the skin caused by light absorption and reflection by the blood vessels beneath the skin. The app uses the front camera of an iPhone or iPad to capture videos of the subject. Then, the algorithm in the app detects and tracks the subject's face to capture the subtle light changes reflected in the changes in RGB pixel values. This information is sent to PanopticAl's cloud server for further processing to calculate the pulse rate. The pulse rate value is then returned to the PanopticAl Vital Signs app, and the result is displayed on the app.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the PanopticAI Vital Signs device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Endpoint)	Target	Reported Device Performance (iPhone)	Reported Device Performance (iPad)
Accuracy (overall RMSE)	Below 3 BPM	Demonstrated to be substantially equivalent to predicate (RMSE)	Demonstrated to be substantially equivalent to predicate (RMSE)
Overall Mean Bias	Below 3 BPM	Below 3 BPM	Below 3 BPM
95% CI of Upper Limit of Agreement [LoA]	Within ± 5 BPM (inclusive)	(2.3094 to 3.0645) - Within criteria	(2.5285 to 3.4571) - Within criteria
95% CI of Lower Limit of Agreement [LoA]	Within ± 5 BPM (inclusive)	(-2.1954 to -1.4402) - Within criteria	(-3.0104 to -2.0818) - Within criteria
Correlation coefficient	Not explicitly stated as a numerical target, but "met"	"Met"	"Met"
Intercept of zero within 95% CI	Contained within 95% CIs	"Met"	"Met"
Slope of one within 95% CI	Contained within 95% CIs	"Met"	"Met"
Subgroup analysis (Bias, LoA within ±5 BPM)	Expected to be met across subgroups	Majority of 95% CI of LoA within ±5 BPM	Majority of 95% CI of LoA within ±5 BPM (exceptions for Heart Shape and History of Hypertension in iPad subjects, but absolute bias still within 3 BPM)
Performance with glasses	No significant difference	No significant difference	No significant difference
Performance with extreme heart rate (50-60 BPM)	No significant difference	No significant difference	No significant difference
Performance with extreme heart rate (100-130 BPM)	No significant difference	No significant difference	No significant difference
Performance with make-up	No significant difference	No significant difference	No significant difference
Performance at distance (0.4 m and 0.6 m)	No significant difference	No significant difference	No significant difference
Performance with facial hair	No significant difference	No significant difference	No significant difference
Performance at luminosity (100 lux and 500 lux)	No significant difference	No significant difference	No significant difference

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

Sample Size (Clinical Validation Study): N=107
Data Provenance: The document does not explicitly state the country of origin. It describes participants based on gender, age, BMI, facial shape, history of hypertension, race/ethnicity (Asian, Black, Hispanic, White), and Fitzpatrick Skin Type Scale. The study appears to be prospective since it's a clinical validation study aiming to assess agreement between the device and a "standard pulse rate measurement by a clinician."

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

The document mentions "standard pulse rate measurement by a clinician" as the ground truth. It does not specify the number of clinicians or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth. The ground truth was based on "standard pulse rate measurement by a clinician."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes a clinical validation study comparing the device's performance to a clinician's standard measurement. It does not mention an MRMC study or the effect size of human readers improving with AI assistance. The device is a standalone measurement tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The clinical validation study directly assesses the PanopticAI Vital Signs app's accuracy against a clinical standard, demonstrating its performance without human interpretation of its outputs beyond what is displayed by the app itself. The device is intended for "non-invasive spot measurement of pulse rate," implying a direct output from the algorithm.

7. Type of Ground Truth Used

The ground truth used was expert consensus / clinical measurement from a "clinician" performing "standard pulse rate measurement."

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set. It focuses solely on the clinical validation (test) set.

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

Since the training set sample size is not provided, how its ground truth was established is also not described in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 23, 2024

PanopticAI Technologies Limited % Jing Chen Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building 300 Hennessy Road Hong Kong, 0000 Hong Kong

Re: K240890

Trade/Device Name: PanopticAI Vital Signs Regulation Number: 21 CFR 870.2785 Regulation Name: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate Regulatory Class: Class II Product Code: QME Dated: November 26, 2024 Received: November 26, 2024

Dear Jing Chen:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Kimberly N. Digitally signed by Kimberly N. Crowley -S Crowley -S

For: Jennifer Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240890

Device Name

PanopticAl Vital Signs

Indications for Use (Describe)

The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects.

The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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007_510K SUMMARY

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1. Date Prepared

25-Nov-24

2. Submitter's Information

2.1. Name of Sponsor:

PanopticAl Technologies Limited

2.2. Address:

Room A, Ground Floor, 3 Tin Hau Temple Road, North Point, Hong Kong

2.3. Contact Name:

Kyle Wong

2.4. Telephone No .:

+852 9231 3712

2.5. Fax No .:

+852 2187 2341

2.6. Email Address:

kylewong@panoptic.ai

ന് Trade Name, Common Name, Classification

3.1. Trade/Product Name:

PanopticAl Vital Signs

3.2. Common or Usual Name:

Vital Signs

3.3. Regulation name:

Software for optical camera-based measurement of pulse rate, heart rate, breathing, and/or respiratory rate

3.4. Regulation Number:

21 CFR 870.2785

3.5. Device Class:

Class II

3.6. Product Code:

QME

4. Identification of Predicate Device

K211906 Oxehealth Vital Signs

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5. Indications for Use

The PanopticAl Vital Signs device is intended for non-invasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera.

The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects.

The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring.

Device Descriptions 6.

Image /page/6/Figure/8 description: The image shows a flowchart describing the process of capturing and processing vital signs using PanopticAI Vital Signs. The process starts with capturing video using an iPhone/iPad. Then, PanopticAI Vital Signs converts the video frame to RGB data, and sends the RGB data to Vital Sign Engine Service on the cloud server. Finally, Vital Sign Engine Service converts RGB data to pulse rate on the cloud server and returns processed pulse rate results to PanopticAI Vital Signs.

■ The Vital Sign Engine Service is a proprietary cloud-based software developed by PanopticAl that uses algorithms to analyze and convert RGB data collected from PanopticAl Vital Signs to pulse rate

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tracks the subject's face to capture the subtle light changes reflected in the changes in RGB pixel values. This information is sent to PanopticAl's cloud server for further processing to calculate the pulse rate. The pulse rate value is then returned to the PanopticAl Vital Signs app, and the result is displayed on the app. Please note that neither the PanopticAl Vital Signs app nor PanopticAl's cloud server saves any personal identifiable information (PI).

It is important to note that while the PanopticAl Vital Signs app can be a useful tool for tracking pulse rate trends over time, however, it should not be relied on for the diagnosis or treatment of medical conditions.

Consideration of Special Control Guidance 7.

A complete set of software documentation, demonstrating that the software Special Controls 1) are met, is described in Section 018 of this submission and objective evidence appended in the identified attachments.
Clinical evidence was supplied in Section 022 of this submission and objective evidence 2) appended in the identified attachments.
Human factors and usability engineering assessments were provided in Section 020 of this 3) submission.
1. Labelling complying with special controls is described in Section 015 and the proposed instructions for use are provided in Appendix 15A. Relevant information supporting the continued conformance with Special Controls are provided in more detail in Section 015 and Section 018.

Comparison to the Predicate Device 8.

The PanopticAl Vital Signs device is substantially equivalent to the predicate device, K211906 Oxehealth Vital Signs, in terms of intended use and technological characteristics. The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness, and safety of the subject device.

	Subject Device	Predicate Device (K211906)
Trade Name	PanopticAl Vital Signs	Oxehealth Vital Signs
Manufacturer	PanopticAl Technologies Limited	Oxehealth Limited	Comments
Device Class	Class II	Class II	Same
Product Code	QME	QME	Same
Regulationnumber	870.2785	870.2785	Same
RegulationName	Software for optical camera-basedmeasurement of pulse rate	Software for optical camera-basedmeasurement of pulse rate, heart rate,breathing rate, and/or respiratory rate	Same
Intended Use	Non-invasive spot pulse rateassessment while the subject ismotionless.	Non-invasive spot check measurementsof pulse rate and breathing rate (chestwall movements)	Similar
Indications forUse	The PanopticAl Vital Signs device isintended for noninvasive spotmeasurement of pulse rate whenthe subject is still. It is software forassessing facial video streamcaptured from a specifiedsmartphone or tablet camera.	The Oxehealth Vital Signs device isintended for noninvasive spotmeasurement of pulse rate andestimated breathing rate (chest wallmovements) when the subject is still. It issoftware assessing video footage from afixed-installation solution for use within	Different(a)
	Subject Device	Predicate Device (K211906)
Trade Name	PanopticAl Vital Signs	Oxehealth Vital Signs
Manufacturer	Panoptical Technologies Limited	Oxehealth Limited	Comments
	The PanopticAl Vital Signs deviceis intended for use by healthcareprofessionals. The device is onlyintended to be used in healthysubjects. The PanopticAl VitalSigns device is indicated for useon humans 18 to 60 years of agewho do not require critical care orcontinuous monitoring. ThePanopticAl Vital Signs device is notintended to be the sole method toassess a subject's physical healthcondition. The pulse ratemeasurements it provides shouldcomplement, not replace,professional medical care and/ormedication.	Single occupancy rooms within hospitals,general care, and secured environmentswith professional healthcare oversightand where a framework exists whichmandates periodic checks by a trainedprofessional to ensure subject safety.The Oxehealth system is intended for useby appropriately trained staff with a dutyof care and should not be used byuntrained users.The Oxehealth Vital Signs device isindicated for use on humans 18 years ofage or older who do not require criticalcare or continuous vital signs monitoring.The device is not intended to be the solemethod of checking the physical healthof a subject.
ProductAvailability	Prescription use	Prescription use	Same
TargetPopulation	Adults 18 to 60 years of age who donot require critical care or ongoingvital signs monitoring. Healthysubjects.	Adults 18 years of age or older who donot require critical care or continuousvital signs monitoring.	Same
Users	Healthcare practitioners	Trained professional healthcare	Same
Clinical setting	Well-lit room; home use & Generalclinic use	Single occupancy rooms Withinhospitals, general care, and securedenvironments.	Different(a)
Human Factors	Compliance with IEC 62366	Compliance with IEC 62366	Same
Design	Software medical device designedto capture signals from video andmeasure pulse rate from a user.Software user interface designed toallow users to take a spotmeasurement of pulse rate.	Software medical device designed toextract signals from video to andmeasure pulse rate and breathing ratefrom a patient.Software user interface designed toallow users to take a spot checkmeasurement of pulse rate andbreathing rate, and to see previouslyobtained measurements.	Similar
Performance	50 to 130 beats per minute, 30second measurement window.	Pulse rate measurement 50 to 130 ± 3beats per minute, 9 secondmeasurement window.Estimated breathing rate (chest wallmovements)Measurement 8 to 31 ± 2 breaths perminute, 30 second measurementwindow.* Accuracy uses the RMSE CriterionPulse rate accuracy may be reducedwhen the subject has a pulse rategreater than 110 beats per minute.	Same
User Interface	User interface accessed byiPad/iPhone	Web-based user interface accessed bytouch screen monitor exclusively servingthe Oxehealth software.	Different(b)
Compatibilitywith Hardware	iPad Air (5th generation) andiPhone 13 Pro with operating	Standard, off the shelf computers andmobile devices, specified and installed	Different(b)
	Subject Device	Predicate Device (K211906)
Trade Name	Panoptical Vital Signs	Oxehealth Vital Signs
Manufacturer	PanopticAl Technologies Limited	Oxehealth Limited	Comments
		by Oxehealth, and validated duringinstallation.
Compatibilitywith Hardware- camera &accessories	iPad Air (5th generation) andiPhone 13 Pro with operatingsystem iOS/iPadOS 16.0 or above	Standard, off the shelf machine visioncamera and infrared illuminators, exactspecification determined by Oxehealthand validated during installation.	Different(b)
ClinicalPerformance	iPhone:95% CI for the Upper [LoA]=(2.3094 to 3.0645)95% CI for the Lower [LoA]=(-2.1954 to -1.4402)Bias (Mean of Absolute Difference)=0.9935iPad:95% CI for the Upper [LoA]=(2.5285 to 3.4571)95% CI for the Lower [LoA]=(-3.0104 to -2.0818)Bias (Mean of Absolute Difference)=1.1598RMSE demonstrated to besubstantially equivalent	RMSD - bpm1.81 bpm (97.5% CI, 0 - 2.19)	Same

A detailed comparison to the predicate is provided in the following table:

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Discussion of differences in technological characteristics 9.

The subject device has similar intended use, design, and performance when compared to the predicate device. The basic technological and operating principles are the same for both devices.

a) There are differences between the subject and predicate devices indicated uses. The differences can be described as below:
- . Product Availability - The subject device is intended for home and general clinic use. The predicate device is intended for use in hospitals, general care, and secured environments.

The usability study and product performance test were conducted to demonstrate the safety of the subject device.

b) The difference in platform hardware compatibility and user interface does introduce any new risk because software validation was conducted to demonstrate the safety and performance of the subject device.
The above differences do not raise questions of safety and effectiveness. Thus, the devices are substantially equivalent.

10. Non-clinical Testing Summary

10.1.Software

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Device Software Functions". The software for this device only requires basic documentation.

10.2. Usability

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The Usability evaluation for the PanopticAl Vital Signs is conducted in accordance with ANSI AAMI IEC 62366-1:2015+AMD1:2020. The usability verification are well defined with criteria specified in the Usability Engineering Report. Usability testing results and improvement action demonstrated that residual risk regarding usability is minimized and acceptable. It is concluded that the usability evaluation is well performed and acceptable.

10.3. Cybersecurity

Because the device is network connected, cybersecurity testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to support adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle.

10.4. Performance Testing - Bench

10.4.1. Glasses

A bench test was undertaken to verify the accuracy of the PanopticAl Vital Signs app with subjects wearing glasses versus those without.

It is concluded that there is no significant difference between the reference method and the subject devices across the participants with or without glasses.

10.4.2. Extreme heart rate

A bench test was conducted to verify whether extreme heart rate, specifically defined as 50-60 BPM and 100-130 BPM, would affect PanopticAl Vital Signs app's accuracy and performance on both types of subject devices, iPhone and iPad.

It is concluded that there is no significant difference between the reference method and the subject devices across the participants with a heart rate range of 50-60 BPM or with a heart rate range of 100-130 BPM.

10.4.3. Make-up

A bench test was conducted to verify whether make-up covering the face would affect PanopticAl Vital Signs app's accuracy and performance for both types of subject devices iPhone and iPad.

It is concluded that there is no significant difference between the reference method and the subject devices across the participants with or without make-up.

10.4.4. Distance

A bench test was conducted to verify PanopticAl Vital Signs app's accuracy and performance between a measuring range of 0.4 m and 0.6m for both types of subject devices - iPhone and iPad.

It is concluded that there is no significant difference between the reference method and the subject devices at a measuring range of 0.4 m and 0.6m.

10.4.5. Facial hair

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A bench test was conducted to verify whether facial hair covering the face would affect PanopticAl Vital Signs app's accuracy and performance for both types of subject devices iPhone and iPad.

It is concluded that there is no significant difference between the reference method and the subject devices across the participants with or without facial hair.

10.4.6. Luminosity

A bench test was conducted to verify PanopticAl Vital Signs app's accuracy and performance between 100 lux and 500 lux for both types of subject devices - iPhone and iPad.

It is concluded that there is no significant difference between the reference method and the subject devices at different lighting conditions.

11. Clinical Testing Summary

This clinical study aimed to assess the agreement between Vital Sign App and the standard pulse rate measurement by a clinician by using Bland-Altman and regression analysis.

The demographic characteristics of the study participants are summarized in the table below.

Sample Size	N=107
Gender	Females: 52Males: 55
Age Group	18-30: 4131-50: 3551-60: 31
BMI	Normal: 46Obese: 10Overweight: 51
Facial Shape	Heart: 10Oblong: 19Oval: 27Round: 37Square: 14
History of Hypertension	With: 6Without: 101
Race/Ethnicity	Asian: 17Black: 25Hispanic: 30White: 35
Skin Type According to FitzpatrickScale	I: 23II: 26III: 19IV: 13V: 12VI: 14

Clinical Validation Study Subject Demographic

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lt was shown that all of the following endpoint criteria were met.

I Bias
I 95% CI of Upper/Lower Limit of Agreement
I Correlation coefficient
I The intercept of zero and the slope of one are contained within the 95% Cls

These results were shown consistently across the following subgroups: -

I Gender
I Age
I Race/Ethnic
I Skin Color
I BMI
I Facial Shape
I History of Hypertension

For Subgroup analysis, please refer to page 16-25 of RD-730-04-20241121 [Clinical Validation Study Report].

The analysis revealed that, the overall RMSE, the overall mean bias, the mean bias of the subgroups were below the criteria of 3 BPM, indicating minimal systematic differences between the two measurement methods.

I Majority of 95% Cl of upper and lower Limits of Agreement [LoA] across all the subgroups were consistently found to be within the endpoint criteria of ± 5 BPM (inclusive), suggesting that the majority of differences fall within the acceptable range. The only two exceptions existed for iPad subjects with Heart Shape and History of Hypertension. Given that their absolute bias is still within 3 BPM, these 2 deviations are probably due to small sample size where normality may not be adequately attained. This does not have significant impact on the device accuracy.
The PanopticAl Vital Signs device is an accurate and high-performance device in pulse rate measurement.

Device accuracy was not compromised by gender, age, skin color, blood pressure, BMI, race/ethnic as well as facial shape.

This study has demonstrated that the device is accurate and comparable to the standard measurement in the intended conditions.

12. Conclusions

Based on the information provided in this 510(k) submission, the differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.

Regulation Number and Section

§ 870.2785 Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

(a)
Identification. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate. This device is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:
(i) A full characterization of the software technical parameters, including algorithms;
(ii) If required image acquisition hardware is not included with the device, full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements;
(iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;
(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and
(v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.
(2) Clinical data must be provided. This assessment must fulfill the following:
(i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.
(ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.
(iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner.
(3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.
(4) Labeling must include:
(i) A description of what the device measures and outputs to the user;
(ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results;
(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;
(iv) The expected performance of the device for all intended use populations and environments; and
(v) Robust instructions to ensure correct system setup.