(137 days)
The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse and respiration 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) and respiration rate (RR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR and RR 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. Additionally, this system utilizes software for optical camera-based measurement of respiration rate. The non-contact, periodic, spot measurement of respiration rate is taken when the subject is at rest based on shoulder movement.
Here's a breakdown of the acceptance criteria and the study proving the Informed Vital Core Application (IVC App) meets them, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance for Informed Vital Core Application (IVC App)
The IVC App (v2.0.0.2.0.0) is intended for non-invasive spot measurement of pulse and respiration rate in adult patients. The performance claims for the device are presented in the following table.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Claimed Performance) | Reported Device Performance (from Clinical Study) |
|---|---|---|
| Pulse Rate (PR) | 50 to 103 bpm, ± 3 bpm | Not explicitly reported in the provided text for the clinical study. The clinical study summary only details the respiration rate findings. |
| Respiration Rate (RR) | 8 – 30 ± 3 breaths per minute (Accuracy uses RMSE criterion) | Hypothesis Accepted: IVC App can measure RR within ± 3 breaths per minute ARMS (Average Root Mean Square). The study found the IVC App can effectively measure respiration rate within the claimed range. |
Note: While acceptance criteria for Pulse Rate are stated in the comparative table, the clinical study summary specifically focuses on the respiration rate's performance. It is implied that the pulse rate performance was either established through other means (e.g., non-clinical testing, equivalence to predicate) or not the primary focus of this specific clinical study summary.
2. Sample Size and Data Provenance
- Test Set Sample Size: The clinical study enrolled 65 subjects (35 healthy patients and 29 patients with comorbidities).
- Data Provenance: The study was conducted at six study sites located in the United States. The data origin is prospective, as described by the "clinical study was conducted" and "study recruited subjects" phrasing.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: The text states, "The clinicians counting the raw EtCO2 waveform were blinded to the results from the test device." It does not specify the exact number of clinicians used, but explicitly refers to them as "clinicians."
- Qualifications of Experts: The specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in the provided text. However, they are described as "clinicians," implying medical professionals capable of accurately counting end-tidal CO2 waveforms.
4. Adjudication Method for the Test Set
- Adjudication Method: The ground truth for respiration rate was established by "blinded, manually-counted end-tidal CO2 (EtCO2) with an FDA-cleared capnography device." The term "blinded" implies efforts to prevent bias, and "manually-counted" suggests human assessment. However, there is no explicit mention of an adjudication process like 2+1 or 3+1 if there were multiple clinicians involved in counting the waveforms for a single case. It only states they were "clinicians counting," not how disagreements (if any) were resolved or if multiple clinicians independently counted each waveform.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess how human readers improve with AI vs. without AI assistance. The study described is a single-arm cohort study evaluating the device's accuracy against a gold standard for respiration rate measurement, not a human-in-the-loop performance study.
6. Standalone (Algorithm Only) Performance
- Standalone Performance Done?: Yes, the clinical study primarily assesses the standalone performance of the IVC App's algorithms for measuring respiration rate. It compares the device's output directly to the gold standard (blinded, manually-counted EtCO2). The device is a "Software as a Medical Device (SaMD)" that outputs vital signs measurements.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for respiration rate was established using expert consensus/measurement from an objective, FDA-cleared device. Specifically, it was "blinded, manually-counted end-tidal CO2 (EtCO2) with an FDA-cleared capnography device." This combination leverages both objective physiological signals (EtCO2 waveform) and expert interpretation/counting of those signals.
8. Sample Size for the Training Set
- Training Set Sample Size: The provided document does not specify the sample size or details about the training set used for the IVC App's algorithm development. The "Summary of Clinical Testing" section pertains to the validation/test study.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set Established: The document does not specify how the ground truth for the training set was established. This information is typically part of the device's development and validation process but is not included in the provided 510(k) summary for this clearance.
§ 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.