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The Pneupac compPAC 200 ventilator is a self contained portable gas powered automatic ventilator intended to provide emergency ventilation, in a battlefield environment only, to adult and pediatric patients greater than 20 kg. The compPAC 200 is suitable for emergency and transport use in situations where conventional portable ventilators are not suitable.

The compPAC COM 200 ventilator is primarily gas powered and is housed in an easily carried, chemically hardened housing. The housing is designed to accept the long endurance battery that is used to drive a small compressor, which in turn provides the inflating gas, through an 'oscillator', to the casualty. All ambient air for the ventilation of the casualty passes into the system through a filter (NATO No: 4240-01-361-1319). About 1/3 of the volume is compressed to drive the ventilator before expansion in an entrainment mixing device, which entrains the other 3/3 by creating a sub-atmospheric pressure. It can be operated from a range of power sources: Battery/ Compressed gas/ Mains Electricity (via power supply/ charger unit) and Auxiliary vehicle electrical source (via power supply/ charger unit) to provide maximum flexibility of operation in remote areas, in military campaigns and in disaster relief.

The compPAC COM 200 ventilator is a robust self-contained portable device comprising of the following standard kit parts:

• Control Module -●
• Green case variant: Part No 510A2433 . OR
• Yellow case variant: Part No 510A2434 ●
• Rubber Boot: Part No 510A2271 .
• Filter: Part No W7265 ●
• Patient Valve and Hose assembly: Part No 510A1082 .
• O2 Auxiliary gas input lead, Schrader probe (BS5682): Part No -- 510A2600 .
• Support ramp: Part No 510A2372 ●
• 28 volt open-ended Vehicle Supply lead to compPAC: Part No 510A2564 ●
• compPAC C200 User Manual: Part No -- 504-2055/A ●

And the following fitted labels:

• Valance Panel Label: Part No 504-228 .
• Instrument Panel Label: Part No 504-227 ●
• Supplementary O2 Table Label: Part No 504-224 ●
• . Battery fitting and removal instruction Label: Part No - 504-223
• Alarm Bezel Label (set of 2): Part No 504-222 ●

The module can be used individually as a robust seff-contained portable device powered by a NiCad rechargeable battery specified for fitting inside the unit, will provide approximately 2 hours continuous ventilation. The module weighs 18.7 lb with the battery installed. The ventilator has a socket to accept an external 24V d.c. supply from e.g. a vehicle electrical circuit. This enables the system to be used for extended periods wherever a 24-28V d.c. supply is available. The power requirement is less than 50 watts. If the Pneupac PS11 power supply (weight: 3.86 lb) is connected to this socket, simultaneous trickle charging of internal battery will occur whilst the ventilator is running. When not required as a power supply it can be switched. to fast charge the battery whilst it is in situ inside the ventilator.

An input gas connector is provided to allow the compPAC ventilator to be connected to a 44 to 87 psig gas supply so that it can be operated independently of its internal battery electrical supply. In this way, if oxygen cylinders or liquid oxygen are available, 100% or 45% oxygen can be supplied to the casualty and the internal battery can be conserved. This facility also allows connection to air compressor systems.

Alternatively, there is a supplementary oxygen intake connector, in parallel with the filter, enabling 21-45% oxygen to be supplied to the casualty, from e.g. an oxygen cylinder, when the ventilator is operating on its compressor.

Calibrated controls for frequency and tidal volume are provided to set the required ventilation pattern. A fixed pressure relief valve is fitted to limit the peak inspiratory pressure to a maximum of 60 cm H2O and provides a pneumatically operated audible high-pressure alarm (an adjustable pressure relief device will also be available in the future as a retro-fittable option). In addition an electronic high-pressure alarm sounds if the inflation pressure exceeds 60 cm H>O.

Most of the controls and input and output connections are mounted on the front panel, which is deeply shrouded to give maximum protection from chemical "rain".

The module control panel has the following features:

• . Minute Volume Control, This calibrated rotary control knob gives continuous adjustment of the minute volume delivered to the patient over the range 6 to 14 L/min.
• Frequency Control, This rotary control knob gives continuous adjustment of frequency over . the range 10 to 30 breaths per minute.

The I:E ratio is nominally constant at 1:1.6 throughout the range of frequency.

• . Patient Inflation Pressure Manometer, range -10 to +100 cm H2O.
• Oxygen Concentration Control This two-position rotary control knob selects either the 100% . or 45% inspired oxygen concentration when an oxygen supply is connected to the gas-input connector. When no external gas is connected this switch is disabled internally. In the 45% O2 position the driving gas requirement is reduced by 66% and the balance of the gas supplied to the patient is entrained atmospheric air which is drawn through the filter canister.
• A mechanically operated visual alarm gives a warning that the supply gas has dropped to a . pressure at which the ventilator will no longer be operating to specification (

Here's a breakdown of the acceptance criteria and study information for the Pneupac compPAC 200 ventilator, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "comparative testing... across the ventilator's entire range," suggesting a comprehensive evaluation of the device's functional parameters rather than a specific patient or clinical sample size.
   • Data Provenance: The testing was performed internally by Pneupac Ltd. (United Kingdom) and subjected for regulatory review by the FDA (USA). The nature of the tests (safety, environmental, functional comparison) indicates a laboratory-based, prospective testing approach rather than analysis of pre-existing patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is defined by technical specifications, established safety and performance standards (EN794-3, EN60601-1, FDA guidance), and comparison to a predicate device, rather than expert interpretation of a clinical dataset.

3. Adjudication method for the test set: Not applicable, as the evaluation is based on objective measurements against engineering and safety standards, not subjective assessments requiring adjudication.

4. 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. This document describes a medical device (ventilator) and its regulatory clearance, not an AI-powered diagnostic or assistive technology.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone medical device (ventilator), and its performance is evaluated directly without a human-in-the-loop component in the context of this regulatory submission.

6. The type of ground truth used: The ground truth is based on:

   • Technical Specifications: The inherent design and expected performance metrics of the ventilator (e.g., minute volume, frequency range, pressure relief limits).
   • International and National Standards: Compliance with recognized medical device safety and performance standards (EN794-3, EN60601-1, FDA Draft Reviewer's Guidance).
   • Predicate Device Performance: Direct comparison of Minute Volume and Frequency parameters to the Univent Eagle (K905697) to demonstrate functional equivalence.

7. The sample size for the training set: Not applicable. This is a hardware medical device, not an AI/ML algorithm that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, for the same reason as above.

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