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The paraPAC 200D 'Transport' ventilator is a portable, gas powered, time-cycled ventilator that is designed for ventilation during transportation and emergency ventilation of patients who have respiratory distress or insufficiency.

The paraPAC 'Transport' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC "Transport" ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate devices.

The paraPAC 'Transport' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece.

The module weighs 3.1 kilograms.

The module control panel has the following features:

• Adjustable Relief Pressure Control, range 20 to 80 cm H2O. .
• Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. ●
• Inspiratory Time Range 3.0 to 0.5 seconds. .
• . Expiratory Time Range 6.0 to 0.5 seconds.
• Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. .
• Flow Range 0.1 to 1.0 L/sec. .
• Ventilation: Off (Spontaneous breathing)/ On (Spontaneous breathing/ Controlled Mandatory . Ventilation).
• Supply Gas Failure Alarm 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 an analysis of the provided text regarding the acceptance criteria and study for the Pneupac paraPAC 'Transport' model 200D ventilator:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" alongside specific numerical "reported device performance" values in a neat table format for the paraPAC 'Transport' 200D. Instead, it describes a more general approach based on compliance with standards and comparison to predicate devices.

However, based on the description, we can infer some criteria and the general performance outcome:

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

The document does not specify a sample size for the test set in terms of number of devices tested or number of test conditions with specific repetitions. It only states that "Testing was performed to ensure that the paraPAC 'Transport' was safe and would perform within the environment(s) for which it is to be marketed."

The data provenance can be inferred as prospective given that the testing was conducted specifically for this new device (paraPAC 'Transport' model 200D) to demonstrate its safety and effectiveness.

The country of origin for the submitter is the United Kingdom (Pneupac Ltd.), suggesting the testing was likely conducted under UK regulatory and manufacturing standards, even though the submission is to the US FDA.

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

This type of information is not applicable to this submission. The "ground truth" for a medical device like a ventilator is established through objective engineering tests against defined performance specifications and regulatory standards, not expert consensus on interpretations of data. There are no human "experts" establishing ground truth in the way described for AI/ML models analyzing medical images, for example.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of expert interpretation or adjudication panels for the testing of a mechanical ventilator's performance against engineering specifications. The testing involves objective measurements against established technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study focuses on the diagnostic performance of human readers, sometimes with and without AI assistance, typically in image interpretation. This document describes the testing of a mechanical ventilator, which is a different domain.

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

This concept is not directly applicable in the context of a mechanical ventilator as described. The "standalone" performance here refers to the device's ability to meet its technical specifications independently, which is what the performance and environmental testing aimed to establish. However, it's not an "algorithm" in the sense of AI/ML. The device's operation is mechanical and electronic, and its performance was tested without human intervention impacting its core function during the tests (though humans operate the device in real-world use).

7. The Type of Ground Truth Used

The ground truth used for the paraPAC 'Transport' 200D was based on objective measurements against established performance specifications and regulatory standards. This includes:

• Engineering specifications for parameters like adjustable relief pressure, inspiratory time, expiratory time, flow range, patient inflation pressure, and alarm thresholds.
• Compliance with international safety and performance standards (e.g., EN794-3, EN60601-1, EN60601-1-2).
• Comparative performance to predicate devices (babyPAC and paraPAC 'medic') for Tidal Volume, Frequency, Inspiration times, and Expiration time, ensuring performance was "within the specified tolerances."

8. The Sample Size for the Training Set

This is not applicable. The paraPAC 'Transport' 200D is a traditional mechanical medical device, not an AI/ML system that utilizes a "training set" of data in the common sense. Its design is based on established engineering principles and technology, not on machine learning from a dataset.

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

This is not applicable for the same reason as Item 8.

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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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The paraPAC 200 & 200D are portable, gas powered, time-cycled ventilators that are designed for emergency ventilation of patients who have respiratory distress or insufficiency.

The paraPAC 'Medic' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC 'Medic' ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate device, except for the addition of a mechanically operated gas supply indicator and the addition of a secondary relief valve.

The paraPAC 'Medic' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece. The module is available as either a non- demand version (P200) or demand version (P200D), and weighs 2.7 kilograms (non-demand version) or 3.1 kilograms (demand version) respectively. The module control panel for both models have the following features: Adjustable Relief Pressure Control, range 20 to 80 cm H2O. Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. Tidal Volume Control, range 65 to 1570 ml. Frequency Control, range 8 to 40 b.p.m. with click stop detent at 12 b.p.m. for Cardiopulmonary Resuscitation. Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. Supply Gas Failure Alarm 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 (

The provided document is a 510(k) premarket notification for the Pneupac paraPAC 'Medic' models 200 & 200D ventilators. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data for new device performance acceptance criteria.

Based on the information provided, here's a breakdown of what can be answered:

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

The document doesn't explicitly define a table of acceptance criteria with numerical targets. Instead, it states that the device "passed all of these tests and met all requirements of the standards" and that "All measurements were within the specified tolerances of the ventilators" for the comparison tests.

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 the sample size for any test sets. The data provenance is not explicitly mentioned as a country of origin. The nature of the testing described (compliance with standards, comparison to predicate device) suggests laboratory or bench testing rather than clinical data involving human subjects, so "retrospective or prospective" would not typically apply in the same way.

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)

This information is not applicable and not provided. The testing described is technical and objective (e.g., measuring tidal volume, checking alarm functionality, adherence to standards), not involving subjective expert assessment for ground truth determination.

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

This information is not applicable and not provided. The tests described are objective measurements against specified tolerances and standards.

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

This is not applicable. The device is a ventilator, not an AI-assisted diagnostic tool that would involve "human readers" or an MRMC study.

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

This is not applicable. The device is a mechanical ventilator with electronic alarms, not an algorithm, so "standalone performance" in the context of AI is not relevant.

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

The "ground truth" for the performance claims appears to be:

• International/European Standards: The device's performance was compared against the requirements specified in standards such as EN 794-3, EN 60601-1, and EN 60601-1-2.
• Predicate Device Performance: For delivered Tidal Volume, Frequency, Inspiration times, and Expiration time, the ground truth was the established and accepted performance of the legally marketed predicate devices (paraPAC 'medic' 2 and 2D). The new device was required to perform "the same."

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning model that requires a training set.

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

This is not applicable as the device is not an AI/machine learning model.

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