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The devices in the Model 731 Ventilator Series are indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). When marked with an "MRI conditional" label, they are suitable for use in an MRI environment with appropriate precautions, as defined in the Operation Manual. The Model 731 Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers. The EMV+® and Eagle II'" (with and without MRI label) have a full range of ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV). The AEV® (with and without MRI label) has a more limited range of ventilation modes for less sophisticated operators (AC, CPAP with PS and PPV).

The Model 731 Ventilators are a small, extremely durable, full-featured portable mechanical ventilators designed to operate in hospitals or austere and under-resourced environments. The unit is a volume and pressure targeted, time or flow cycled ventilator designed to use either oxygen (O2) from a 55 psig source or fresh air using its internal compressor to deliver a positive pressure breath. The unit contains a pulse oximeter which is intended for continuous noninvasive monitoring of arterial hemoglobin (SpO2) and pulse rate (measured by the SpO2 sensor). The unit contains various controls and indicators that are placed to facilitate ease of use and visibility in all operating environments. A liquid crystal display (LCD) provides continuous display of control settings, operating conditions, power, and alarm status information. The unit uses a comprehensive suite of alarms to alert the operator and guide their actions to resolve the alarm condition and assure patient safety. At the onset of an alarm, the screen displays the alarm name and then a series of context-sensitive help messages. These messages serve to guide the operator by presenting suggestions as to the cause and resolution of a particular alarm. When multiple alarms occur they are prioritized and displayed based on the risk to the patient. The unit offers a range of modes using both pressure and volume targeting that can be selected to optimally manage the patient. Assist/Control (AC): patient receives either controlled or assisted breaths. When the patient triggers an assisted breath they receive a breath based on either the volume or pressure target. Synchronized Intermittent Mandatory Ventilation (SIMV): patient receives controlled breaths based on the set breathing rate. Spontaneous breaths can be either unsupported demand flow or supported using Pressure Support. (This mode is not available in the AEV® unit.) Continuous Positive Airway Pressure (CPAP): patient receives constant positive airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow or supported using Pressure Support. The unit contains a built-in back up ventilator mode that is designed to provide a limited degree of operation should certain types of failures occur to the primary operating system. The unit can be used in environments where chemical and/or biological toxins are present. To do this safely, all gas delivered to the patient comes from either a pressurized medical-grade O₂ source and/or filtered ambient air entrained through the FRESH GAS/EMERGENCY AIR INTAKE. Operators can chose between a bacterial/viral filter and a chemical/biological filter based on the direction of the Medical Control Officer. To prevent the patient from breathing contaminated ambient air in the event of a ventilator failure, the unit contains an internal anti-asphyxia valve that allows the patient to inspire gas through the external filter. The unit continuously monitors environmental conditions (temperature and ambient pressure) and when extreme environments are detected the operator is alerted by a low priority alarm which defines the operating condition and prompts the actions of the operator. The unit uses a rechargeable lithium-ion battery which offers a wide temperature operating range, does not exhibit "memory" characteristics (reduced capacity) or vent hydrogen gas. The unit can use O₂ from low flow sources, O₂ flow meters and O₂ concentrators, to provide supplemental O₂ to patients. To do this, O₂ is entrained through the Fresh Gas/Emergency Air Intake when the unit's internal compressor cycles to deliver a breath. The testing in MRI environment was done with a 3.0 T Siemens Trio scanner, which has a magnetic field of 0.2 T (500 gauss) at a distance of slightly more than 1 meter (~3.3 feet) from the bore entrance. There was no effect on either the ventilator functionality or the MRI performance at a distance of 2 meters.

The provided text is a 510(k) summary for the Uni-Vent® Model 731 Series Portable Critical Care Ventilators. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared device (K103318), with the main difference being the addition of operation in an MRI environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of patient data. The evaluation appears to be entirely non-clinical performance testing focused on the device's interaction with an MRI environment and its functional performance. No human subjects were involved. As such, there is no sample size for a test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Since the performance evaluation was non-clinical testing of device functionality and MRI compatibility, there was no "ground truth" to be established by experts in the context of medical diagnoses or interpretations. The acceptance criteria were met through direct measurements and observations during testing.

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

Not applicable. As noted above, there was no "test set" involving human interpretation or diagnosis that would require an adjudication method.

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

No MRMC comparative effectiveness study was done. This submission is for a medical device (ventilator), not an AI-based diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm or AI system. Its performance was evaluated as a standalone medical device in various operational conditions, including an MRI environment.

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

The "ground truth" for the non-clinical performance evaluation was based on predefined engineering specifications, regulatory standards (e.g., ASTM F1100), and the physical effects measured during MRI compatibility testing. For example, "no effect on ventilator functionality" or "no effect on MRI performance" measured against established baselines determined the passing criteria.

8. The sample size for the training set

Not applicable. This device is a ventilator, not an AI or machine learning system that requires a "training set."

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

Not applicable. As there is no training set for this device, there is no ground truth establishment method for it.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests.

• MRI Compatibility Testing: The primary study mentioned is testing for MRI environment compatibility. This involved placing the ventilator near a 3.0 T Siemens Trio scanner which has a magnetic field of 0.2 T (500 gauss) at approximately 1 meter. The testing demonstrated "no effect on either the ventilator functionality or the MRI performance at a distance of 2 meters." This test was conducted in accordance with the acceptance criteria defined in the FDA Draft Guidance "A Primer on Medical Device Interactions with Magnetic Resonance Imaging systems," covering aspects like location of testing, imaging sequence, effect on medical device, and generation of artifact/noise, all of which "passed."
• Breathing Circuit Performance: The longer breathing circuit required for MRI operation was tested and "passed testing to ASTM F1100 requirements."
• Waveform and Volume Performance: Sections 5.3 and 5.4, related to "Waveform Performance" and "Volume Performance" respectively, also "passed." (Specific details of these tests are not provided in this summary but are indicated as having met their criteria).

In summary, the provided document details a non-clinical evaluation to demonstrate the safe and effective operation of the Uni-Vent® Model 731 Series Portable Critical Care Ventilators, particularly in an MRI environment, by meeting specific pre-defined performance and safety criteria through direct physical testing and measurement against established standards.

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