(401 days)
The Vivo 45 LS ventilator (without the SpO2 and CO2 sensors) is intended to provide continuous or internittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (1 1bs.), however, the mouthpiece ventilation modes are for adult patients only.
The Vivo 45 LS with the SpO2 sensor is intended to measure function of arterial hemoglobin (% SpO2) and pulse rate.
The Vivo 45 LS 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 applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.
The Vivo 45 LS 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.
Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.
Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.
The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.
The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.
The provided FDA 510(k) summary (K193586) describes the Breas Medical AB Vivo 45 LS ventilator. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing an independent clinical study with acceptance criteria in the way a de novo device might.
Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics for the device for a standalone clinical study. Instead, performance testing focused on verifying conformance with requirements specifications and applicable standards, and comparative testing with predicate devices. The acceptance criteria are implicitly tied to meeting these standards and demonstrating substantial equivalence.
Here's an attempt to infer and summarize the performance goals and how they were met based on the provided text:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to Electrical Safety Standards (e.g., ANSI/AAMI ES60601-1) | Verified conformance with ANSI/AAMI ES60601-1:2005. |
| Conformance to Electromagnetic Compatibility Standards (e.g., IEC 60601-1-2) | Verified conformance with IEC 60601-1-2: 2014. |
| Conformance to Usability Standards (e.g., IEC 60601-1-6) | Verified conformance with IEC 60601-1-6: 2010+A1:2013. Summative usability/human factors testing found the Vivo 45 LS to be safe and effective for intended users, uses, and environments (including respiratory therapists, registered nurses, and lay caregivers). |
| Conformance to Alarm System Standards (e.g., IEC 60601-1-8) | Verified conformance with IEC 60601-1-8: 2006 + Am. 1: 2012. Alarms testing confirmed proper operation of physiologic and technical alarms. |
| Conformance to Home Healthcare Environment Standards (e.g., IEC 60601-1-11) | Verified conformance with IEC 60601-1-11: 2015. |
| Conformance to Critical Care Ventilator Standards (e.g., ISO 80601-2-12) | Verified conformance with ISO 80601-2-12:2011. |
| Conformance to Respiratory Gas Monitor Standards (for CO2 sensor, e.g., ISO 80601-2-55) | Verified conformance with ISO 80601-2-55: 2018. The CO2 sensor is intended to measure CO2 in inspiratory and expiratory gas. |
| Conformance to Pulse Oximeter Equipment Standards (for SpO2 sensor, e.g., ISO 80601-2-61) | Verified conformance with ISO 80601-2-61:2017. The SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. |
| Conformance to Home Healthcare Environment Ventilator Standards (e.g., ISO 80601-2-72) | Verified conformance with ISO 80601-2-72:2015. |
| Battery Performance (IEC 62133) | Verified conformance with IEC 62133: 2012. Power management testing confirmed proper operation including transitions between power sources, alarms, and battery operating time. |
| Biocompatibility (ISO 18562 series) | All materials in the gas pathway were evaluated for VOCs (ISO 18562-3), particulates (ISO 18562-2), and inorganic gases (CO, CO2, Ozone) per ISO 18562-1 recommendations. No VOC compounds observed in toxicologically significant quantities. Particulate quantities were well below acceptable limits. Device was found not to generate carbon monoxide, carbon dioxide, or ozone. |
| Waveform Accuracy (Flow, Pressure, Volume) | Waveform performance testing conducted comparing Vivo 45 LS to Vivo 60 (and Trilogy EVO for MPV modes). The comparison of recorded waveforms supports the claim that Vivo 45 LS is substantially equivalent to predicate devices. |
| Triggering Performance | Triggering testing showed that the Vivo 45 LS performed as intended, detecting each patient effort within permissible trigger delay without false-triggers. |
| Accuracy of Controls and Monitored Values | Testing confirmed that the Vivo 45 LS meets its accuracy specifications. |
| Performance of Mouthpiece Ventilation (MPV) and SIMV modes | Testing of MPV and SIMV modes was performed and the Vivo 45 LS passed all tests. |
| Cybersecurity | Verified conformance with all cybersecurity specifications. |
| RFID Immunity | Passed all RFID immunity tests to AIM standard 7351731 (134 kHz and 13.56 MHz RFID sources). |
| Software Verification and Validation | Performed at unit, integration, and system level according to plans and protocols with predetermined pass/fail criteria. All tests passed. |
| Cleaning Validation | Performed to ensure no physical or performance degradation occurred. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or clinical samples. The performance testing described is primarily bench testing against engineering specifications and industry standards, and comparative testing against predicate devices (Vivo 60 and Trilogy Evo). Therefore, concepts like country of origin or retrospective/prospective data provenance are not applicable in the context of this device's testing as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the typical sense. The "ground truth" for the engineering performance tests is derived from established engineering principles, international standards, and the performance characteristics of the predicate devices.
However, for summative usability/human factors testing, the document mentions the involvement of:
- Respiratory therapists
- Registered nurses
- Lay caregivers
Their collective feedback and performance in simulated use scenarios would have served as the "ground truth" for assessing the device's usability and human factors safety. The exact number of each type of professional is not specified.
4. Adjudication method for the test set
Not explicitly stated for the engineering and comparative tests. The passing of tests against specifications and standards implies adherence to predefined pass/fail criteria. For the usability testing, "was found to be safe and effective" suggests a consensus or evaluation against usability requirements, but a specific adjudication method (e.g., 2+1) is not detailed.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a ventilator, not an AI-assisted diagnostic tool for "human readers." The comparative testing performed was between the Vivo 45 LS and its predicate devices (Vivo 60 and Trilogy Evo) to demonstrate technological equivalence, not to evaluate human performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself (the "algorithm only" being the device's operational logic and hardware). The document describes extensive standalone performance testing of the Vivo 45 LS against various standards and specifications. This includes:
- Waveform performance (flow, pressure, volume)
- Triggering performance
- Accuracy of controls and monitored values
- Performance of specific ventilation modes (MPV, SIMV)
- Alarm system operation
- Power management
- Cybersecurity
- RFID immunity
- Software verification and validation
- Biocompatibility
These tests evaluate the device's inherent function without human intervention during the measurement or operation for the test itself, thus representing its standalone technical performance.
7. The type of ground truth used
The ground truth for the various performance tests was primarily based on:
- International and National Standards: e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 80601 series, ISO 18562 series. The criteria within these standards define what constitutes acceptable performance.
- Device Specifications: The manufacturer's own predefined accuracy specifications and operational parameters.
- Predicate Device Performance: For comparative testing, the performance of the legally marketed predicate devices (Vivo 60 and Trilogy Evo) served as a benchmark for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This document describes the premarket notification for a medical device (ventilator), not a machine learning or AI algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or AI algorithm for which ground truth would be established.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).