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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

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.

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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.

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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