(165 days)
The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse rate of adult patients in home use, hospitals, clinics, and long-term care settings.
The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring.
Informed Vital Core is not intended to independently direct therapy.
The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR of the individual. The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for the device's accuracy is clearly stated: pulse rates measured with the IVC App must be accurate to within ±3 beats per minute (BPM) Average Root Mean Square (ARMS) of heart rates (HR) measured with a reference ECG device.
| Acceptance Criteria (Pulse Rate Accuracy) | Reported Device Performance (Pulse Rate Accuracy) |
|---|---|
| Within ±3 BPM Average Root Mean Square (ARMS) of Heart Rate (HR) measured with a reference ECG device | The hypothesis that the IVC App can measure PR within ± 3 BPM ARMS is accepted. (Implicitly, the performance met this criterion.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 67 subjects were enrolled in the clinical study.
- Data Provenance:
- Country of Origin: United States (recruited from six study sites located in the United States).
- Retrospective or Prospective: Prospective. The study is described as a "multicenter, prospective, open-label clinical study."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth was established by a legally marketed, electrocardiogram (ECG) device, which serves as the reference standard for heart rate measurement. Therefore, no human experts were involved in creating the ground truth for the clinical study's primary endpoint.
4. Adjudication Method for the Test Set
No adjudication method is mentioned or relevant, as the ground truth was established by an objective medical device (ECG), not by human readers requiring consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the IVC App compared to an ECG device. There is no mention of human readers assisting with the device or comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "Primary endpoint" states: "The primary objective of the study was to establish that pulse rates measured with the IVC App are accurate to within ±3 beats per minute (BPM) average root mean square (ARMS) of heart rates (HR) measured with the reference ECG device." This directly assesses the algorithm's performance without human intervention in the measurement process itself, beyond initial setup.
7. Type of Ground Truth Used
The ground truth used was objective measurement from a legally marketed medical device, specifically an electrocardiogram (ECG) device. The document explicitly states: "The PR obtained by the IVC App was compared to the heart rate obtained by the ECG reference device."
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for the training set. It provides "Bench Testing Subject Demographics" with "Subjects (Unique): 711" and "Number of Sessions: 1,413". While these subjects and sessions were used for "Non-clinical tests," it's not explicitly stated that this dataset was used for training the algorithm. It likely represents a larger dataset used for internal development, validation, and potentially training, but the text doesn't provide a distinct "training set size."
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly detail how the ground truth for the training set was established. However, given the nature of the device and the testing described, it can be inferred that ground truth for any training data would also have been established using reference medical devices (like ECG, pulse oximeters, etc.) to obtain accurate heart rate measurements, similar to how the test set ground truth was established. The "Device Description" mentions "The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR," implying the training would involve establishing relationships between video signals and actual pulse rates from such reference devices.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
November 18, 2024
Mindset Medical, Inc. Jeremy Markovich Vice President of Regulatory and Clinical Affairs 12439 N 32nd St. Phoenix, Arizona 85032
Re: K241633
Trade/Device Name: Informed Vital Core Application (IVC App) 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: October 19, 2024 Received: October 21, 2024
Dear Jeremy Markovich:
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 medical devices and radiation-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,
Jennifer W. Shih -S
Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices 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)
Device Name
Informed Vital Core Application (IVC App)
Indications for Use (Describe)
The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse rate of adult patients in home use, hospitals, clinics, and long-term care settings.
The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring.
Informed Vital Core is not intended to independently direct therapy.
Type of Use (Select one or both, as applicable)
( Prescription Use (Part 21 CFR 801 Subpart D)
Over The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image contains a logo for Informed Mindset Medical. The logo consists of a blue square with a white medical cross inside, with red accents in the corners of the cross. To the right of the square are the words "INFORMED" in bold, followed by "MINDSET MEDICAL" in a smaller font.
510(k) Summary
| Company Address: | Mindset Medical, Inc.14239 N. 32nd StPhoenix, AZ 85032602.481.4139 |
|---|---|
| Primary Contact Person: | Chris JoslinVice President of Product Management and Compliance |
| Date Prepared: | October 18, 2024 |
| Device Name: | Informed Vital Core Application (IVC App) |
| Common Name: | Cardiovascular Monitoring Device |
| Classification: | 21 CFR 870.2785 Software for Optical Camera-Based Measurement ofPulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate |
| Product Code: QME | |
| Regulatory Class: II | |
| Predicate Device: | Oxehealth Vital Signs (K211906) |
| Purpose: | This submission is seeking clearance for the IVC App. |
| Device Description: | The IVC App is a Software as a Medical Device (SaMD) progressive webapplication that utilizes existing optical camera technology embeddedin a smart-phone, tablet, laptop, or desktop computer to estimate anindividual's vital signs including pulse rate (PR) developed by MindsetMedical. The IVC App software algorithms will provide spot checks forPR of the individual. The IVC App software uses proprietary softwarealgorithms to extract a raw video signal through remoteplethysmography (rPPG) by detecting subtle color variations in themicrovasculature around a patient's face that occur with each cardiaccycle due to changes in blood volume to measure PR. |
| Evidence was provided to demonstrate compliance with the specialcontrol for product code, QME, per 21 CFR 870.2785 for the softwarefor optical camera-based measurement of pulse rate, heart rate,breathing rate, and/or respiratory rate. | |
| Indications for Use: | The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse rate of adult patients in home use,hospitals, clinics, and long-term care settings. |
| The Informed Vital Core Application is indicated for use on adults 22years of age or older who do not require critical care or continuousvital signs monitoring. | |
| Informed Vital Core is not intended to independently direct therapy. | |
| TechnologicalCharacteristics: | The IVC App has similar technological characteristics to the predicatedevice, including remote photoplethysmography (rPPG) technology,algorithms for video analysis, off the shelf system components such asa computer, laptop, or mobile device, and utilization of software tomeasure the pulse rate using commercially available cameras. The IVCApp is comparable to the predicate in terms of intended use,fundamental scientific technology, technological characteristics, andprinciple of operation. |
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Image /page/5/Picture/0 description: The image contains a logo for a medical company. On the left side of the logo is a blue square with rounded corners. Inside the square is a white medical cross with red accents on the corners. To the right of the square are the words "INFORMED" in large, bold, gray letters, and below that are the words "MINDSET MEDICAL" in smaller, gray letters.
Substantial Equivalence Comparison Summary:
| Device | Subject Device,Informed Vital Core Application (IVC App) | Predicate Device (K211906)Oxehealth Vital Signs |
|---|---|---|
| Manufacturer | Mindset Medical | Oxehealth Limited |
| Intended Use | Non-invasive spot check measurements of pulse rate. | Non-invasive spot check measurements of pulse rate andbreathing rate (chest wall movements). |
| Indications for use | The Informed Vital Core Application (IVC App) isintended for non-invasive spot measurement ofpulse rate of adult patients in home use, hospitals,clinics, and long-term care settings. | The Oxehealth Vital Signs device is intended fornoninvasive spot measurement of pulse rate andestimated breathing rate (chest wall movements) whenthe subject is still. It is software assessing video footagefrom a fixed- installation solution for use within single |
| The Informed Vital Core Application is indicated foruse on adults 22 years of age or older who do notrequire critical care or continuous vital signsmonitoring. | occupancy rooms within hospitals, general care, andsecured environments with professional healthcareoversight and where a framework exists which mandatesperiodic checks by a trained professional to ensuresubject safety. | |
| Informed Vital Core is not intended toindependently direct therapy. | The Oxehealth system is indicated for use by appropriatelytrained staff with a duty of care, and should not be usedby untrained users. | |
| The Oxehealth Vital Signs device is indicated for use onhumans 18 years of age or older who do not requirecritical care or continuous vital signs monitoring. | ||
| Device | Subject Device,Informed Vital Core Application (IVC App) | Predicate Device (K211906)Oxehealth Vital Signs |
| The device is not intended to be the sole method ofchecking the physical health of a subject. | ||
| Regulationnames andnumbers | 21 CFR 870.2785Software for optical camera-based measurementof pulse rate, heart rate, and respiratory rate. | 21 CFR 870.2785Software for optical camera-based measurement of pulserate, heart rate, and respiratory rate. |
| Product codesandclassifications | Code: QMEClass: II | Code: QMEClass: II |
| Use population | Adults not requiring critical care | Adults not requiring critical care |
| Useenvironment | Homes, hospitals, clinics, long-term care settings | Hospitals, general care, and similar professionalhealthcare environments |
| Systemcomponents | Computer, laptop, mobile phone, or tablet | Computer or laptop |
| IVC software application | Software application | |
| No additional hardware components required | Optical sensors installed in patient's room in healthcarefacility | |
| TechnologyCharacteristics | Remote Photoplethysmography (rPPG)technique is used to detect volumetric changes inperipheral blood circulation by using a colormodel based on red, green, and blue imagingderived from real-time video obtained from apatient using a computer, laptop, or mobiledevice.The IVC App's Vital Core Algorithm appliesproprietary signal processing techniques to thepatient video to estimate pulse rate. | Remote Photoplethysmography (rPPG) technique is usedto detect volumetric changes in peripheral bloodcirculation by using a color model based on red, green,and blue imaging derived from real-time video obtainedfrom a patient using a computer, laptop, or mobile device.The device uses proprietary software algorithms toanalyze video signal and estimate pulse rate, heart rate,respiratory rate and/or breathing rates. |
| Measurementsite | Face | Face |
| Measurementtype | Spot | Spot |
| Performance,Heart rate(pulse rate) | 50 to 103 bpm, ± 3 bpm | 50 to 130 bpm, ± 3 bpm |
| Measurementwindow | 60 seconds | 30 seconds |
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Image /page/6/Picture/0 description: The image contains the logo for Informed Mindset Medical. The logo consists of a blue square with rounded corners, inside of which is a white plus sign with red accents in each corner. To the right of the square are the words "INFORMED" in large, bold, gray letters, and below that are the words "MINDSET MEDICAL" in smaller, lighter gray letters.
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Image /page/7/Picture/0 description: The image contains the logo for Informed Mindset Medical. The logo consists of a blue square with rounded corners, inside of which is a white plus sign with red accents in each quadrant. To the right of the square are the words "INFORMED" in bold, dark gray letters, and below that, in smaller, lighter gray letters, are the words "MINDSET MEDICAL."
Performance Testing:
| Test | Results |
|---|---|
| Software testing | Verification and validation testing of the IVC App software's was conducted to confirm that the device meets the performance requirements and indications for use across different system configurations of smartphones, tablets, and laptops. This includes a full characterization of software technical parameters and algorithms. Non-clinical tests were conducted to demonstrate the accuracy of the measured pulse rates using the IVC App. The accuracy of the measured IVC App pulse rates compared to a legally marketed pulse rate measurement device during bench testing demonstrated within ±3 bpm root mean square error (RMSE). Verification and validation testing was performed to ensure hardware compatibility based on the defined minimally required specifications (e.g., physical parameters and performance characteristics) for the cameras to ensure the quality of captured images/videos and the PPG signals. A risk-based approach was utilized for human factors and usability assessment. This included testing to evaluate the application response (e.g., prompts, labeling, and user alerts) to expected fault conditions caused by patients or incompatibility from the hardware of mobile devices such as phones or tablets. |
| Cybersecurity testing | A cybersecurity threat analysis was conducted using FDA Guidance and AAMI/TIR57:2016/R2019 as a framework. All system components were assessed for potential cybersecurity vulnerabilities. Additional third-party penetration testing was conducted to identify any cybersecurity vulnerabilities in the IVC System. Any detected vulnerabilities were addressed by design and/or testing. |
| Description | Number of Sessions | |
|---|---|---|
| Subjects(Unique) | 711 | 1,413 |
| Age Range | 18 to 21 | 135 |
| 22 to 29 | 290 | |
| 30 to 39 | 222 | |
| 40-49 | 169 | |
| 50-59 | 268 | |
| 60-69 | 208 | |
| 70-79 | 89 | |
| 80-89 | 20 | |
| 90-99 | 7 | |
| Sex | Males | 515 |
| Females | 898 | |
| Race | AmericanIndian/Alaskan | 12 |
Bench Testing Subject Demographics
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Image /page/8/Picture/0 description: The image contains the logo for Informed Mindset Medical. The logo consists of a blue rounded square with a white plus sign in the center. The plus sign has a small red triangle in each corner. To the right of the square is the text "INFORMED" in bold, dark gray letters. Below that is the text "MINDSET MEDICAL" in a smaller, lighter gray font.
| Asian | 26 | |
|---|---|---|
| Black/AfricanAmerican | 279 | |
| Pacific Islander | 14 | |
| White | 1003 | |
| Other | 79 | |
| BMI ranges | <18.5 | 15 |
| 18.5 to 24.9 | 462 | |
| 25 to 29.9 | 450 | |
| 30 to 39.9 | 409 | |
| >40 | 77 | |
| Skin typeaccording toFitzpatrick Scale | Type 1 and 2 | 719 |
| Type 3 and 4 | 424 | |
| Type 5 and 6 | 270 | |
| Glasses (Y/N) | Yes | 448 |
| No | 965 | |
| Facial Hair(Y/N) | Yes | 309 |
| No | 1104 | |
| Environment | Office | 38 |
| Clinic | 1042 | |
| Home | 81 | |
| Indoors (general) | 44 | |
| Outdoors | 3 | |
| Not reported | 205 |
Summary of Clinical Testing:
Study design - A multicenter, prospective, open-label clinical study was conducted on the IVC App demonstrating its accuracy for pulse rate measurements compared to a legally marketed, electrocardiogram (ECG) device.
Primary endpoint – The primary objective of the study was to establish that pulse rates measured with the IVC App are accurate to within ±3 beats per minute (BPM) average root mean square (ARMS) of heart rates (HR) measured with the reference ECG device.
The hypothesis was tested by comparing the IVC PR to the subject's HR simultaneously measured with a legally marketed reference device. The study recruited subjects from six study sites located in the United States. The PR obtained by the IVC App was compared to the heart rate obtained by the ECG reference device. The Average Root Mean Square (ARMS) and its 95% confidence interval were calculated. The hypothesis that the IVC App can measure PR within ± 3 BPM ARMS is accepted. The study was not powered to demonstrate statistical significance in sub-groups; however, sub-group
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Image /page/9/Picture/0 description: The image contains the logo for Informed Mindset Medical. The logo consists of a blue square with rounded corners, inside of which is a white medical cross with red accents in each corner. To the right of the logo is the word "INFORMED" in bold, gray letters. Below that is the phrase "MINDSET MEDICAL" in smaller, gray letters.
accuracy was calculated to ensure adequate performance. Based on the results of the IVC App is effective at determining pulse rate in an intended use population.
| Description | Number | |
|---|---|---|
| Subjects | Total | 67 |
| Age | 22-29 | 6 |
| 30-39 | 16 | |
| 40-49 | 9 | |
| 50-59 | 10 | |
| 60-69 | 20 | |
| 70-77 | 6 | |
| Gender | Males | 30 |
| Females | 37 | |
| Race/Ethnicity | American Indian or Alaska Native | 1 |
| American Indian or Alaska Native/Black or African American | 1 | |
| Asian | 5 | |
| Black/African American | 18 | |
| Pacific Islander | 1 | |
| White | 40 | |
| Other | 1 | |
| Skin type according to Fitzpatrick Scale | Type I and II | |
| Type III and IV | 18 | |
| Type V and VI | 18 |
Clinical Study Subject Demographics
Conclusion:
The IVC App has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).
§ 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.