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The Pneupac compPAC 200HD ventilator is a self contained portable gas powered automatic gas ventilator intended to provide ventilation to patients who have respiratory ditress or insufficiency. The comPAC 200HD is suitable for emergency and transport use for adult and paediatric patients greater than 20Kg in situations where convential portable ventilators may not be suitable

The compPAC COM 200HD ventilator is primarily gas powered and is housed in an easily carried, chemically hardened 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 fitter (NATO No: 4240-01-361-1319). About '// of the volume is compressed to system uncough in the (cre expansion in an entrainment mixing device, which entrains the other 1/3 by creating a sub-atmospheric pressure It can be operated from a range of power sources Battery! Compressed gass! Mains Electricity (via PS11 power supply/ charger unit) and any d.c. power source, ie: auxiliary aircraft/vehicle electrical source (via CS12 power supply/ charger unit) to provide maximum flexibility of operation in remote areas, in disaster relief.

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

• Control Module
• Green case variant: Part No 510A2433
• Yellow case variant: Part No 510A2434
• Rubber Boot: Part No 510A2271
• Filter: Part No W194-001
• Patient Valve and Hose assembly: Part No 510A1082
• Oz 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 C200HD User Manual Part No 504-2055A NUS HD

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 self-contained portable device powered by a NiCad rechargeable battery specified for fitting inside the unit, which will provide approximately (1) hours continuous ventilation. The module weighs 187 lb with the battery installed. The ventilator has a socket to accept an external 24V d c supply from e g. an aircraft or 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 CS12 (d.c. source only) power supply) battery charger (weight 2.2 lbs) is connected to this socket, simultancous full charging of the internal battery will occar whilst the ventilator is running.

If the Pneupac PSI i (inains or d.c. source) power supply / battery charger (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.

Additionally, specifically for aircraft use, an aeromedical EMC filter/ lead assembly (Part No 525-1015) is featured to protect the aircraft from compPAC emissions.

An input gas connector is provided to allow the compPAC ventilator to be connected to a 44 to 87 psig gas supply via a legally registered high pressure regulator (not suppliated with the material battered battered hence not part of this submission) so that it can be operated independently of its its internal battery electrical supply In this way, if oxygen cylinders are available, 100% or 4.5% or allows electrical supply in this way. In usygen cymiders are are This facility also allows connection to air compressor systems.

Alternatively, there is a supplementary oxygen intake connector, in paralied with the filter, enabling 21-45% oxygen to be supplied to the casualty, from e g an oxygen cylinder was a legally registered high pressure regulator (not supplied with the compPAC, hence not part of this registeres ), when the ventilator is operating on its compressor.

Calibrated controls for frequency and minute volume are provided to set the required ventiation pattern. A fixed pressure relief valve is fifted to limit the peak inspiratory pressure to a maximum of 40 cm HzO and provides a pneumatically operated audible high-pressure alarm (an adjustable pressure relief device will also be available in the fittere as a retro-fittable option). In addition an pressure reach device the alarm sounds if the inflation pressure exceeds 40 cm HzO.

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

The ventilator module comrol 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 adjussment of frequency over the range 10 to 30 breaths per minute
• I:E ratio is nominally constant at 1. i. 8 throughout the range of frequency
• Patient Inflation Pressure Manometer, range -10 to +100 cm HpO
• Oxygen Concentration Control This two-position rovary control in assessed to the eas-후 100% or 45% inspired oxygen concentration when an oxygen supply is connected to the gas-100% or 43% inspired oxygen concentralion withis systed is disabled internally. In the 45% Oz position the driving gas requirement is reduced by 66% and the balance of the In the 45% U position the driving gas requirement arr which is drawn through the fifter canister
• A mechanically operated visual alarm (labelled 'Supply Gas Failure Alam') gives a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be warming that the supply gas nas artipped to a pressure it shows red, with adequate its suces the operating to specificated ( red indicates that the supply should be changed In most cases the shows will begin to oscillate from white to parial red as the supply pressure falls to the lower threshold level.

The visual indication will be accompanied by an electronically generated medium priority audible warning.

• Electronic aların bezel indicating
• High Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and with continuous positive pressure
• Normal Cycle Indicator Flashes Green LED every time inflation pressure rises through 10 cm H2O
• Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure does not rise through 10 cm H2O within ten seconds.
• Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to the operator that the audible alarm is silenced.
• Electrical power indicator Flashes Yellow LED with audible alarm

The CS12 power supply and battery charger designed to power the comply has the The CS12 power supply and Dattery from an aircraft or vehicle 24-28V dc supply has the following controls and features:

The CS12 power supply and battery charger complements the complexe with a nominal 12/24/28 vol The CS12 power supply and battery charged from any source with a nominal 12/24/28 vol. allows the ventilator's battery to be charged from the second with annoly allows the ventilator's battery to be clarged from any only be operated simultaneously if the supply D.C. aircraft/ vehicle supply. The ventilator may only be operated simult D.C. aircrato vemere supply. The following controls and features

• DC Outputs protected outputs to power the ventilator and supply a constant current to charge the +28Vdc battery
• Start Button initiates a battery charging cycle If held for a few seconds, it will also terminate any battery charging cycle underway
• POWER Yellow Lamp 'charge only' indicates aircraft/ vehicle supply voltage is only sufficient (10-22V) to charge the battery
• POWER Green Lamp 'compPAC & charge' indicates aircraft/ vehicle supply voltage is POWER Green Lamp compt AC of charge its battery simultator and charge its battery simultancously
• CHARGE Yellow Lamp 'Charging' indicates a battery charging cycle is underway
• CHARGE Green Lamp 'Complete' indicates the battery charging cycle has been successfully completed

The PS11 Dower supply/ charger designed to power the compPAC 200HD ventilator and The ESTI Dower Support Chartery from a Mains (230 or 115 volt nominal AC operation) or d.c. (12 to 30 volt d c ) supply has the following controls and features

• Line Output In conjunction with the negative common, a -28V dc output for general Lifte Output = In conjunction with the negarres battle when the appropriate lead is fitted. The output is fully protected against short circuits and overload
• Trickle charge output In conjunction with the negative common, a +28V dc ourput I rickle charge output - In complise ventilator This line provides a trickle charge facility for the compPAC's internal battery
• Battery Charge Output In conjunction with the negative common, this is the output used to charge a +28V dc NiCad battery
• On/Off Switch The switch on the from panel of the PS11 selects two different operating modes -
• 28V de & Trickle Clug. ON: This activates the 28V dc Line and Trickle Charge outputs and open circuits the compPAC internal battery
• Output OFF & Charge Battery This activates the Battery Charge output and removes power from the 28V dc Line and Trickle Charge outputs.

Additionally, specifically for aircraft use, an aeromedical EMC filter/ lead assembly (Part No: 525-1015) is featured to protect the aircraft from compPAC emissions.

When the compleAC is operating its imernal compresson, the incoming air is filtered. The specifications of the recommended filter are as follows -

• Fifter efficiency is at least 99.99% efficient against a 0.3um Mass Median Aerodynamic Diameter aerosol challenge at 32 L/min
• Airflow resistance at 32 Liters per Minute is 10 to 17 mm HzO
• Connector size is 40mm DIN NATO compatible threads

The Pneupac compPAC 200HD ventilator, PS11 Power supply/charger, and CS12 d.c. Power supply/charger submissions do not provide a table of acceptance criteria or details on a specific study designed to prove the device meets these criteria in a quantitative sense as might be seen for AI/ML device submissions.

Instead, the submission focuses on demonstrating safety and effectiveness through compliance with several established international and national standards, and comparison testing against predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit table of acceptance criteria with corresponding performance metrics is provided in the document. The document primarily focuses on demonstrating compliance with recognized standards.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The provided document concerns a medical device, a powered ventilator, rather than an AI/ML system. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not directly relevant. The testing performed was related to engineering and safety standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This information is relevant for AI/ML performance evaluation where human experts establish ground truth for model training and testing. For this medical device, safety and performance were evaluated against established engineering and medical device standards.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in clinical studies for AI/ML devices to resolve discrepancies in ground truth labeling.

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

Not applicable. This is specific to AI/ML devices that assist human readers. The compPAC 200HD is a standalone ventilator.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done through a series of tests against specified standards and comparison with predicate devices.

7. Type of Ground Truth Used

The "ground truth" for this device can be understood as:

• Compliance with established engineering and medical device standards: These standards define acceptable levels of safety and performance (e.g., EN60601-1, EN794-3, BS EN 61000 series, Generic Specification for Special Purpose Aeromedical Equipment).
• Performance of predicate devices: The compPAC 200HD's performance was compared to the predicate compPAC 200 and ParaPAC 200 Medic ventilators to ensure functional equivalence.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Device Performance (Based on provided text)

While specific numerical acceptance criteria and performance data are not presented in a table, the document states:

• "Safety testing was conducted in accordance with the Draft Reviewer's Guidance for Ventilators, 'FDA Draft Requirements for emergency and transport ventilators' 1999 and EN60601-1 'Medical Electrical equipment – Part 1 General requirements for safety'."
• "The ventilator and power supply/charger passes all of these tests and met all requirements of the standards."
• "Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and environmental performance testing has been completed. The results demonstrated that the compPAC 200HD ventilator, PS11 Mains/d.c. Power supply/charger and CS12 d.c. Power supply/charger complied with the guidelines and standards and that they performed within their specifications and functional requirements."
• "Comparison testing of the compPAC model 200HD with its predicate counterparts the compPAC 200 and paraPAC 200 Medic was done to ensure the performance of the delivered Volume and Frequency parameters are the same to each other throughout the entire range. All measurements were within the specified tolerances of the ventilators. These tests were applied to both the compPAC 200 and paraPAC 200 Medic."
• "The testing described above indicates that there is no functional difference between the operation of the compPAC model 200HD with its predicate counterparts during the measurement of these performance parameters. Based on these results, it is our determination that the device model is safe, effective and performs as well as the legally marketed predicate devices."

In essence, the "acceptance criteria" were the requirements of the listed medical device and electrical engineering standards, and the "study" demonstrating compliance was a series of engineering and safety tests, along with comparison testing to predicate devices. The device was deemed to have met these implicitly defined acceptance criteria by successfully passing all tests and demonstrating equivalent performance to the predicate devices.

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