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The Vivo 50 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing at least 10 kg (22 lbs.).

The Vivo 50 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 50 with the CO2 sensor is intended to measure CO2. in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 50 is not intended to be used as a transport and critical care ventilator.

The Vivo 50 Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Internal flow and pressure are read through flow/ pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both as graphs and numbers.

All the operator actions are performed via the front panel where clear buttons and screen are located. There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 50 can be operated by external AC or DC power supply and contains an integroted battery as well as an additional click on battery.

The Vivo 50 can be used with both single limb patient circuits including an active exhalation valve and single limb patient circuits including a leakage port.

The Vivo 50 can be operated in 9 different ventilation modes:

• . PSV - Pressure Support Ventilation
• PSV(TgV) Pressure Support Ventilation with Target Volume .
• PCV Pressure Controlled Ventilation
• PCV(TgV) Pressure Controlled Ventilation with Target Volume
• PCV(A) Assisted Pressure Controlled Ventilation
• PCV(A+TaV) Assisted Pressure Controlled Ventilation with Taraet Volume ●
• VCV Volume Controlled Ventilation
• VCV(A) Assisted Volume Controlled Ventilation ●
• CPAP Continuous Positive Airwav Pressure ●

The internal memory data of the Vivo 50 can be downloaded to a PC, printed out, and analysed via the Vivo 50 PC Software. The Vivo 50 PC Software is the support software for follow-up on patient treatment. The PC Software can communicate with the ventilator in two ways, either using an USB cable or a Compact Flash memory card.

The Vivo 50 PC Software provides presentation features of logged data by 24 hours, 30 days and 365 days resolution. The Vivo 50 PC Software presents treatment parameters such as pressure, volume, flow, leakage but also events such as alarms and change of settings. Further, the hours of usage is presented.

The Vivo 50 with the iOxy kit , consisting of an SpO2 (blood oxygen saturation) Nonin sensor, an electronic unit and cable, is intended to be connected to ventilator for logging SpO2 and pulse rate data and, when applicable, for real time monitoring. The SpO2 and pulse rate measurements are stored in the Vivo 50 internal memory log which can be downloaded to a PC and viewed in the Vivo 50 PC software. The SpO2 sensors are manufactured by Nonin Medical Inc.

The Vivo 50 with the CO2 sensor can be connected with the purpose to measure and display End Tidal CO2 (EtCO2) as well as Inspired CO2 (InspCO2). The EtCO2 displays the end-tidal carbon dioxide, measured on the last portion of the exhaled volume. The InspCO2 displays the inspired carbon dioxide.

The CO2 sensor can be connected to the patient breathing circuit and to the Vivo 50 in order to monitor and store CO2 measurements. The CO2 measurements will be stored in the Vivo 50 data memory which can be downloaded to a PC and viewed in the Vivo 50 PC software.

The CO2 sensor used with the Vivo 50 is manufactured by PHASEIN AB and is in used with PHASIEN AB carbon dioxide gas analyser cleared device under K081601 & K123043.

The Vivo 50 Remote Alarm Unit enables care providers and clinical personnel to monitor the Vivo 50 alarms remotely. The Remote Alarm unit is connected to the ventilator via a 10. 25 or 50 meter cable and powered by the ventilator. The Remote Alarm repeats alarms from the Vivo 50. The alarm signal sound level may be adjusted by the user. The actions or adjustments on the Remote Alarm unit do not, in any way, affect the alarm indications, alarm sound level, or audio pause on the Vivo 50.

This device is a ventilator, and the provided document is a 510(k) summary for its clearance. For ventilators, acceptance criteria and associated "studies" typically refer to compliance with recognized standards and internal verification/validation testing rather than clinical performance studies measuring accuracy metrics like sensitivity/specificity against ground truth. The document explicitly states that no clinical studies were required or performed to support substantial equivalence for the Vivo 50.

Therefore, the "acceptance criteria" for this device are its compliance with various medical device standards and the internal non-clinical testing performed by the manufacturer.

Here's the information extracted and formatted as requested, with explanations where direct answers are not applicable due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. The submission explicitly states "The subject of this premarket submission, Vivo 50 did not require clinical studies to support substantial equivalence." The testing described is non-clinical (verification and validation against specifications and standards), not a clinical 'test set' with patient data.
• Data Provenance: Not applicable, as there was no clinical test set using patient data. All testing mentioned is internal, non-clinical lab/bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There was no clinical test set requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. No MRMC study was mentioned or performed. This device is a standalone ventilator, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• The performance testing and standards compliance outlined in "Summary of Non-Clinical Tests" represent the standalone performance of the device against its specifications and relevant standards. This is not a specific "algorithm-only" study in the sense of a diagnostic AI, but rather the integrated system's performance. The device's functionality (e.g., controlling ventilation modes, displaying parameters, managing alarms) is intrinsically "standalone" in its operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For non-clinical verification and validation of a medical device like a ventilator, the "ground truth" equates to the established engineering specifications for the device, and the requirements outlined in the applicable medical device standards (e.g., IEC 60601 series, ISO 9919, ISO 21647, ASTM F1246-91, ASTM F1100). Performance is measured against these objective, predefined criteria.

8. The sample size for the training set:

• Not applicable. This document describes a medical device (ventilator) that underwent traditional engineering verification and validation, not a machine learning or AI algorithm development process that typically involves a "training set."

9. How the ground truth for the training set was established:

• Not applicable. As there was no training set (see point 8), no ground truth was established for it.

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