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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 (< 35 psi). With low pressure it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level.

The visual indication will be accompanied by an electronically generated medium priority (to EN 475) audible warning. In order to conserve the battery, if this audible alarm is ignored for more than 60 seconds the alarm system will ultimately switch itself off.

• Electronic alarm 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.
  • Breathing detect indicator Flashes Green LED each time a spontaneous breath is . detected.
  • Low battery indicator Flashes Yellow LED with audible alarm. .

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 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 (< 35 psi). With low pressure it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases the display will begin to oscillate from white to partial 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. In order to conserve the battery, if this audible alarm is ignored for more than 60 seconds the alarm system will ultimately switch itself off. Electronic alarm 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. Breathing detect indicator (demand model only) Flashes Green LED each time a spontaneous breath is detected. Low battery indicator Flashes Yellow LED with audible alarm.

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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