(266 days)
K211906 Oxehealth Vital Signs
Not Found
Unknown
The description mentions an "algorithm" for face detection and tracking and "further processing" on a cloud server, which could potentially involve AI/ML, but it is not explicitly stated or described in a way that confirms the use of AI/ML. The lack of mention of training or test sets further supports the "Unknown" classification.
No.
The device's intended use is for noninvasive spot measurement of pulse rate, which is a diagnostic function, not a therapeutic one. It provides information to complement, not replace, medical care.
No
The device is intended for noninvasive spot measurement of pulse rate, not for diagnosing a medical condition or disease. The description states it "is not intended to be the sole method to assess a subject's physical health condition" and the measurements "should complement, not replace, professional medical care".
Yes
The device is described as a "medical software device" and its function is based on processing video data captured by a separate, pre-existing hardware (smartphone/tablet camera). The processing and calculation of pulse rate are performed by the software and a cloud server, without the device itself including any dedicated hardware components for measurement.
Based on the provided information, the PanopticAl Vital Signs device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, or other bodily fluids.
- The PanopticAl Vital Signs device analyzes a facial video stream. It measures physiological signals (pulse rate) non-invasively from the surface of the body using remote photoplethysmography (rPPG).
The device falls under the category of a medical software device that performs a physiological measurement. It is a diagnostic device in the sense that it provides information about a physiological state, but it does so through external sensing rather than analyzing a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes
QME
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical camera-based (facial video stream)
Anatomical Site
facial
Indicated Patient Age Range
18 to 60 years of age
Intended User / Care Setting
healthcare professionals. The device is only intended to be used in healthy subjects.
Well-lit room; home use & General clinic use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Sample Size: N=107
Gender: Females: 52, Males: 55
Age Group: 18-30: 41, 31-50: 35, 51-60: 31
BMI: Normal: 46, Obese: 10, Overweight: 51
Facial Shape: Heart: 10, Oblong: 19, Oval: 27, Round: 37, Square: 14
History of Hypertension: With: 6, Without: 101
Race/Ethnicity: Asian: 17, Black: 25, Hispanic: 30, White: 35
Skin Type According to Fitzpatrick Scale: I: 23, II: 26, III: 19, IV: 13, V: 12, VI: 14
Key Results:
- All of the following endpoint criteria were met: Bias, 95% CI of Upper/Lower Limit of Agreement, Correlation coefficient, and The intercept of zero and the slope of one are contained within the 95% CIs.
- These results were shown consistently across the following subgroups: Gender, Age, Race/Ethnic, Skin Color, BMI, Facial Shape, History of Hypertension.
- The overall RMSE and the overall mean bias, and the mean bias of the subgroups were below the criteria of 3 BPM, indicating minimal systematic differences between the two measurement methods.
- Majority of 95% CI 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), with two exceptions for iPad subjects with Heart Shape and History of Hypertension, which were attributed to small sample size and did not significantly impact 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.
Performance Testing - Bench:
- Glasses: No significant difference between the reference method and the subject devices across participants with or without glasses.
- Extreme heart rate (50-60 BPM and 100-130 BPM): No significant difference between the reference method and the subject devices across participants with these heart rate ranges.
- Make-up: No significant difference between the reference method and the subject devices across participants with or without make-up.
- Distance (0.4 m and 0.6m): No significant difference between the reference method and the subject devices at these measuring ranges.
- Facial hair: No significant difference between the reference method and the subject devices across participants with or without facial hair.
- Luminosity (100 lux and 500 lux): No significant difference between the reference method and the subject devices at different lighting conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Overall RMSE (Root Mean Square Error) and mean bias below 3 BPM.
- 95% Confidence Interval of Upper/Lower Limit of Agreement (LoA) mostly within +/- 5 BPM.
- 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) = 0.9935.
- iPad: 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) = 1.1598.
Predicate Device(s)
K211906 Oxehealth Vital Signs
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
3
Indications for Use
Submission Number (if known)
Device Name
PanopticAl Vital Signs
Indications for Use (Describe)
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.
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:
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.
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 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
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
7
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.
-
- 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 |
| Regulation | |||
| number | 870.2785 | 870.2785 | Same |
| Regulation | |||
| Name | Software for optical camera-based | ||
| measurement of pulse rate | Software for optical camera-based | ||
| measurement of pulse rate, heart rate, | |||
| breathing rate, and/or respiratory rate | Same | ||
| Intended Use | Non-invasive spot pulse rate | ||
| assessment while the subject is | |||
| motionless. | Non-invasive spot check measurements | ||
| of pulse rate and breathing rate (chest | |||
| wall movements) | Similar | ||
| Indications for | |||
| Use | 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 Oxehealth Vital Signs device is | ||
| intended for noninvasive spot | |||
| measurement of pulse rate and | |||
| estimated breathing rate (chest wall | |||
| movements) when the subject is still. It is | |||
| software assessing video footage from a | |||
| fixed-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 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. | Single occupancy rooms within hospitals, | ||
| general care, and secured environments | |||
| with professional healthcare oversight | |||
| and where a framework exists which | |||
| mandates periodic checks by a trained | |||
| professional to ensure subject safety. | |||
| The Oxehealth system is intended for use | |||
| by appropriately trained staff with a duty | |||
| of care and should not be used by | |||
| untrained users. | |||
| The Oxehealth Vital Signs device is | |||
| indicated for use on humans 18 years of | |||
| age or older who do not require critical | |||
| care or continuous vital signs monitoring. | |||
| The device is not intended to be the sole | |||
| method of checking the physical health | |||
| of a subject. | |||
| Product | |||
| Availability | Prescription use | Prescription use | Same |
| Target | |||
| Population | Adults 18 to 60 years of age who do | ||
| not require critical care or ongoing | |||
| vital signs monitoring. Healthy | |||
| subjects. | Adults 18 years of age or older who do | ||
| not require critical care or continuous | |||
| vital signs monitoring. | Same | ||
| Users | Healthcare practitioners | Trained professional healthcare | Same |
| Clinical setting | Well-lit room; home use & General | ||
| clinic use | Single occupancy rooms Within | ||
| hospitals, general care, and secured | |||
| environments. | Different | ||
| (a) | |||
| Human Factors | Compliance with IEC 62366 | Compliance with IEC 62366 | Same |
| Design | Software medical device designed | ||
| to capture signals from video and | |||
| measure pulse rate from a user. | |||
| Software user interface designed to | |||
| allow users to take a spot | |||
| measurement of pulse rate. | Software medical device designed to | ||
| extract signals from video to and | |||
| measure pulse rate and breathing rate | |||
| from a patient. | |||
| Software user interface designed to | |||
| allow users to take a spot check | |||
| measurement of pulse rate and | |||
| breathing rate, and to see previously | |||
| obtained measurements. | Similar | ||
| Performance | 50 to 130 beats per minute, 30 | ||
| second measurement window. | Pulse rate measurement 50 to 130 ± 3 | ||
| beats per minute*, 9 second | |||
| measurement window. | |||
| Estimated breathing rate (chest wall | |||
| movements) | |||
| Measurement 8 to 31 ± 2 breaths per | |||
| minute*, 30 second measurement | |||
| window. |
- Accuracy uses the RMSE Criterion
Pulse rate accuracy may be reduced
when the subject has a pulse rate
greater than 110 beats per minute. | Same |
| User Interface | User interface accessed by
iPad/iPhone | Web-based user interface accessed by
touch screen monitor exclusively serving
the Oxehealth software. | Different
(b) |
| Compatibility
with Hardware | iPad Air (5th generation) and
iPhone 13 Pro with operating | Standard, off the shelf computers and
mobile 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 during
installation. | |
| Compatibility
with Hardware
- camera &
accessories | iPad Air (5th generation) and
iPhone 13 Pro with operating
system iOS/iPadOS 16.0 or above | Standard, off the shelf machine vision
camera and infrared illuminators, exact
specification determined by Oxehealth
and validated during installation. | Different
(b) |
| Clinical
Performance | 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)
=0.9935
iPad:
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)
=1.1598
RMSE demonstrated to be
substantially equivalent | RMSD - bpm
1.81 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: 52 |
| Males: 55 | |
| Age Group | 18-30: 41 |
| 31-50: 35 | |
| 51-60: 31 | |
| BMI | Normal: 46 |
| Obese: 10 | |
| Overweight: 51 | |
| Facial Shape | Heart: 10 |
| Oblong: 19 | |
| Oval: 27 | |
| Round: 37 | |
| Square: 14 | |
| History of Hypertension | With: 6 |
| Without: 101 | |
| Race/Ethnicity | Asian: 17 |
| Black: 25 | |
| Hispanic: 30 | |
| White: 35 | |
| Skin Type According to Fitzpatrick | |
| Scale | I: 23 |
| II: 26 | |
| III: 19 | |
| IV: 13 | |
| V: 12 | |
| VI: 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.