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snap40 is intended for reusable bedside, mobile and central multi-parameter, continuous and intermittent physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals.

snap40 is intended to provide visual and audible physiologic multi-parameter alarms.

snap40 is intended for temperature monitoring temperature at the upper arm is clinically indicated.

snap40 continuously monitors the following parameters in adults:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• · Movement

snap40 is intended for intermittent or spot-check monitoring of respiration rate.

snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home

snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor.

snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

snap40 consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station.

snap40 is intended to continuously monitor adult patient vital signs in non-critical areas of the hospital, mainly general medical/surgical units, across pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). snap40 is intended for intermittent or spot-checking monitoring of respiration rate (RESP).

Here's a summary of the acceptance criteria and the studies conducted for the snap40 system, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance specifications rather than explicit acceptance "criteria" in a pass/fail sense, but it does list the accuracy for each monitored parameter. The "Reported Device Performance" column reflects the accuracy achieved in the clinical studies.

2. Sample Sizes and Data Provenance

Oxygen Saturation (SpO2) Test Set:

• Sample Size: 12 participants
• Data Provenance: The document implies these were prospectively collected in controlled desaturation studies. The country of origin is not explicitly stated but is likely the UK, where snap40 Ltd. is located.

Respiration Rate Test Set:

• Sample Size: 37 participants
• Data Provenance: The studies were conducted prospectively, with participants measured in a variety of postures. The country of origin is not explicitly stated but is likely the UK.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

• The document does not specify the number of experts used to establish ground truth for either the SpO2 or respiration rate test sets.
• The document does not specify the qualifications of these experts.
• The document does not mention any adjudication method used for establishing the ground truth.

4. Adjudication Method

As stated above, the document does not mention any adjudication method used for the test set's ground truth.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any data on how much human readers improve with AI vs. without AI assistance. The clinical studies focused on the accuracy of the device itself against established reference methods.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone (algorithm only) performance studies were conducted for both SpO2 and respiration rate. The "Clinical Studies" section explicitly details these:

• SpO2: "controlled desaturation studies were conducted in compliance with IEC80601-2-61 across 12 participants. This testing demonstrated accuracy of +/- 2 digits across the range of 70-100%."
• Respiration Rate: "snap40 was compared to respiration rate measured by end-tidal CO2. This was conducted on 37 participants in a variety of postures. This testing demonstrated accuracy of +/- 1 respirations per minute across a range of 6rpm to 60rpm."

These are direct measurements of the device's algorithmic performance.

7. Type of Ground Truth Used

• Oxygen Saturation (SpO2): The ground truth was established using "controlled desaturation studies" in compliance with IEC80601-2-61, which typically involves comparing the device's readings against a laboratory co-oximeter or arterial blood gas analysis.
• Respiration Rate: The ground truth was established by comparing snap40 readings against "respiration rate measured via end-tidal CO2," which is a clinical standard for respiratory monitoring.
• Temperature: For the non-clinical temperature accuracy test, "compliance with ISO 80601-2-56" would imply comparison against a calibrated reference thermometer.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for training the device's algorithms. It only describes the clinical validation/test sets.

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

The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.

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