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The Pneupac paraPAC plus™ Model 300/310 Ventilators are gas-powered emergency and transport portable ventilators that are primarily intended for use in transport applications in vehicles including fixed and rotary winged aircraft. They are suitable for emergency use at the accident scene, intra and inter-hospital transport and within medical facilities including medical imaging systems to 3 Teslas. They should only be used under the constant supervision of trained healthcare professionals. The devices are intended to provide ventilatory support to adults, children and infants (above approx. 10kg).

The devices also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients.

The Pneupac® paraPAC plus™ Model 300/310 Ventilators are gas powered portable medical devices intended for the ventilation of adults, children and infants (above approximately 10kg (or 22lb)) during transportation and emergency situations.

These models are the enhanced versions of the Pneupac® Parapac® P200D Medic (K020899) gas powered time cycled emergency and transport ventilator which is also one of the predicate devices. Similar to the Pneupac® Parapac P200D, the Pneupac® paraPAC plus™ Model 300/310 Ventilators depend solely on the pressure of the supply gas for their operation. This enables them to be suitable for use in transport applications in vehicles including fixed and rotary winged aircraft.

As with the Pneupac® Parapac® P200D, these models also incorporate an integrated electronic pressure alarm unit to alert the user of certain significant changes (such as for high or low inflation pressure) that may occur in patient's ventilation. Loss of battery power for the alarm is signaled to the user, but will have no effect on the performance of the ventilator, nor affect the pneumatically operated alarms and the ventilators functioning.

Calibrated frequency and tidal volume controls are color coded to indicate the recommended settings for adults, children and infants.

A Positive End Expiratory Pressure (PEEP) control is provided to set PEEP between 0 and 20 cm H2O. It also has a Continuous Positive Airway Pressure (CPAP) control to provide CPAP therapy for spontaneously breathing patients which is also one of the features of the predicate device, the O Two Carevent Systems (K051469). This is achieved by connecting a Pneupac® paraPAC plus™ Disposable CPAP Circuit to the Pneupac® paraPAC plus™ Model 310 Ventilator.

An air mix control in the Pneupac® paraPAC plus™ Model 300/310 Ventilators gives FiQ2 option of 0.50 or 1.0. This enables the device to provide a combination of air and oxygen.

The Pneupac® paraPAC plus™ Model 300/310 Ventilators use currently available technology found in many legally marketed ventilators. Testing was performed to demonstrate that they are safe and would perform within the environment(s) for which they are to be marketed.

The Pneupac® paraPAC plus™ Model 300 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose and a standard disposable patient circuit.

The Pneupac® paraPAC plus™ Model 310 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose, standard disposable patient circuit, CPAP disposable patient circuit and hyperinflation bag (K970785).

The Pneupac® paraPAC plus™ Disposable CPAP Circuit is an air entrainment device with an attached oxygen and pressure monitoring line for connection solely to the Pneupac® paraPAC plus™ 310 Model Ventilators. The Instructions for Use of the Pneupac® paraPAC plus™ Disposable CPAP Circuit state that it can only be used with the Pneupac® paraPAC plus™ Model 310 Ventilator. As the Pneupac® paraPAC plus™ Disposable CPAP circuit cannot be used without the Pneupac® paraPAC plus™ Model 310 Ventilator, the Pneupac® paraPAC plus™ Disposable CPAP circuit is considered as an integral part of the Pneupac® paraPAC plus™ Model 310 Ventilator for the purposes of this Premarket Notification.

The disposable patient circuits provided with the Pneupac® paraPAC plus™ Model 300/310 Ventilators are specifically designed for use with the Pneupac® paraPAC plus™ Model 300/310 Ventilators and the Instructions for Use state that these are the only circuits to be used with the Pneupac® paraPAC plus™ Model 300/310 Ventilators. As the Pneupac® paraPAC plus™ Model 300/310 Ventilators cannot be used without the patient circuit, the patient circuit is considered an integral part of Pneupac® paraPAC plus™ Model 300/310 Ventilators for the purposes of this Premarket Notification.

The provided text describes a 510(k) summary for the Pneupac® paraPAC plus™ Model 300/310 Ventilators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics, rather than clinical efficacy studies with specific acceptance criteria related to a disease outcome or human reader performance.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to the information contained within this document. The document primarily details the device characteristics and the non-clinical testing performed to show that the device performs as intended and is safe.

Here's an analysis of the provided information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of a performance target with a corresponding measured result for specific clinical metrics. Instead, it describes compliance with various standards and satisfactory performance in non-clinical tests. The "reported device performance" is a general statement that the device performed within its specifications and functional requirements and complied with guidelines and standards.

2. Sample size used for the test set and the data provenance

Not applicable. The "testing" primarily refers to non-clinical bench testing, environmental testing, and human factors validation, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of clinical studies, is not established for this type of non-clinical device testing.

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

Not applicable. This is not a clinical study involving adjudication of interpretations.

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

Not applicable. This device is a ventilator, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a ventilator, not an AI algorithm.

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

Not applicable in the clinical sense. For mechanical and environmental testing, the "ground truth" (or reference standard) would be the performance requirements set forth in the cited international and national standards (e.g., specific force for drop test, temperature range, EMC levels, etc.).

8. The sample size for the training set

Not applicable. This is a medical device approval based on substantial equivalence and non-clinical engineering testing, not an AI algorithm requiring a training set.

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

Not applicable.

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The Pneupac VR1 Airmix is a hand-held, portable, time maled, gas powered, flow generator ventilatory resuscitator that is suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. It is designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions: Pneupac VR1 Airmix Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/ insufficiency or no respiratory function and including a control for providing oxygen concentrations of either 100% or 50% nominal.

Pneupac VR1 Airmix is intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and inter- hospital transport. The Pneupac VR1 Airmix allows two modes of ventilation, automatic and manual. In automatic mode the device cycles in accordance with the setting of the single tidal volume/frequency control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and rate possible are limited by the position of the single tidal volume/frequency control. The Pneupac VR1 Airmix includes a control for providing oxygen concentrations of either 100% or 50% nominal. The Pneupac VR1 Airmix uses the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation. The Pneupac VR1 Airmix incorporates a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH2O optional) which operates in an identical manner to the predicate devices. The Pneupac VR1 Airmix consists of a hand-held control module connected to the patient at its outlet via a mask, endotracheal tube or laryngeal mask airway and is used with various patient circuits and accessories comprising the following items; User replaceable patient valve, Oxygen input gas hose assemblies, Breathing filter, Biological breathing filter kit (optional for contaminated atmospheres), Masks, airways and airway adjuncts, Manual suction, Oxygen therapy kits, Oxygen cylinders and regulators, Carrying bag, Breathing circuits, PEEP accessories. The mass of Pneupac VR1 Airmix is 1.001lb, 0.455kg. The Pneupac VR 1 Airmix control module has the following features; Interdependent and continuous control of tidal volume and frequency from 150ml/25bpm to 1050ml/10bpm using a single tidal volume/frequency control, Demand breathing system, Spontaneous breathing under power failure, Audible pressure relief alarm, Integrated, user replaceable patient valve, Automatic or Manual mode selector, Manual mode push button and omni-directional lever, Airmix control for providing oxygen concentrations of either 100% or 50% nominal.

Here's an analysis of the provided 510(k) summary regarding the Pneupac VR1 Airmix device, adhering to your requested format.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial or standalone performance study. Therefore, some of your requested information (e.g., sample sizes for test sets, number of experts for ground truth, MRMC study details) is typically not found in this type of submission.

1. Table of acceptance criteria and the reported device performance

The submission demonstrates the device's performance against established safety and performance standards for ventilators and resuscitators. The acceptance criteria essentially align with meeting the requirements of these standards.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided 510(k) summary. Performance data appears to be based on engineering verification and validation testing of the device itself rather than clinical patient data.
• Data Provenance: The testing was conducted internally by Smiths Medical International Limited (or certified laboratories on their behalf) to comply with recognized international standards (e.g., ASTM, MIL-STD, RTCA, IEC, EN). The country of origin for the data generation would likely be the UK, given the submitter's address. The data is based on the performance of the device itself under various simulated conditions, not retrospective or prospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in this context. The "ground truth" for this type of device (a ventilator) is its ability to meet engineering specifications and performance standards. This is typically assessed through objective measurements against predefined criteria, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., reading medical images). Here, the device's performance is objectively measured against technical 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

No. This device is a medical device (ventilator), not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study and discussions of human reader improvement with AI assistance are irrelevant to this submission.

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

Yes, in a conceptual sense. The "standalone" performance here refers to the device and its components meeting the specified technical and safety standards independently. The performance data presented (e.g., passing ASTM tests, complying with environmental standards) represents the device's inherent capability to function as intended without direct human intervention once configured.

7. The type of ground truth used

The "ground truth" here is defined by the objective, measurable requirements specified in the referenced international standards (e.g., ASTM F 920-93 for minimum performance and safety, MIL-STD, RTCA, IEC, EN for environmental and mechanical tests). The device's performance was compared against these established benchmarks.

8. The sample size for the training set

Not applicable. This device is a mechanical/electrical ventilator, not an AI/ML algorithm that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

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The Pneupac VR1 range are hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. They are designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions:
Pneupac VR1 Standard - Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/insufficiency or no respiratory function.
Pneupac VR1 Responder Basic ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with no respiratory function.

Pneupac VR1 Standard and VR1 Responder is intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and interhospital transport.
The Pneupac VR1 range comprises two variants - Pneupac VR1 (standard model) and Pneupac VR1 Responder (standard model without spontaneous breathing system).
The Pneupac VR1 Standard and VR1 Responder allow two modes of ventilation, automatic and manual. In automatic mode the device cycles in accordance with the setting of the single tidal volume/frequency control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and rate possible are limited by the position of the single tidal volume/frequency control.
The Pneupac VR1 Standard and VR1 Responder use the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation.
The Pneupac VR1 Standard and VR1 Responder incorporate a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH20 optional) which operates in an identical manner to the predicate devices.
The Pneupac VR1 Standard and VR1 Responder consists of a hand-held control module connected to the patient at its outlet via a mask, endotracheal tube or laryngeal mask airway and is used with various patient circuits and accessories comprising the following items;

• User replaceable patient valve
• Oxygen input gas hose assemblies
• Breathing filter
• Biological breathing filter kit (optional for contaminated atmospheres)
• Masks, airways and airway adjuncts
• Manual suction
• Oxygen therapy kits
• Oxygen cylinders and regulators
• Carrying bag
• Breathing circuits
• PEEP accessories
  The specification for the recommended, optional biological breathing filter are as follows;
• Filter efficiency at least 99.99% efficient against a 0.3micron mass median aerodynamic diameter aerosol challenge at 32 1/min.
• Airflow resistance at 32 1/min. is 10-17 mm H2O
• Connector size 40mm DIN NATO compatible threads
  The mass of Pneupac VRI Standard and VRI Responder resuscitators is; Pneupac VR1 0.880lb. 0.400kg Pneupac VR1 Responder 0.825lb, 0.375kg
  The Pneupac VR1 Standard and VR1 Responder standard control module has the following features:
• Interdependent and continuous control of tidal volume and frequency from 150ml/25bpm to 1050ml/10bpm using a single tidal volume/frequency control
• Demand breathing system (not featured on the VRI Responder model)
• Spontaneous breathing under power failure
• Audible pressure relief alarm
• Integrated, user replaceable patient valve
• Automatic or Manual mode selector
• Manual mode push button and omni-directional lever

The provided document describes the Pneupac VR1 Standard and VR1 Responder, which are ventilatory resuscitators. The information primarily focuses on safety and performance testing to ensure compliance with relevant standards, rather than a study with specific acceptance criteria in terms of algorithm performance or human-in-the-loop improvements. This is a premarket notification (510(k)) and largely demonstrates substantial equivalence to a predicate device through engineering and performance testing.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed as compliance with recognized standards and the device performing within its specifications, as well as being comparable to the predicate device. Specific quantitative thresholds for performance are cited from these standards.

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

This document describes hardware testing of a medical device (ventilatory resuscitator), not an AI algorithm. Therefore, concepts like "test set," "sample size," "data provenance," and "country of origin" as they relate to data for AI models are not directly applicable.

The testing involved physical devices and their adherence to engineering standards. The provenance of the device design and manufacturing is Smiths Medical International Limited, based in the UK. The testing itself would have been conducted in a laboratory setting, likely in the UK or a certified testing facility elsewhere. The study is prospective in the sense that the new device was subjected to defined tests to demonstrate compliance.

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

Again, this is not an AI study. "Ground truth" in this context refers to the defined specifications and the requirements of the standards (e.g., ASTM F 920-93). These standards are developed by expert consensus within relevant fields (e.g., medical device engineering, clinical practice), but the document does not detail the number or specific qualifications of individuals involved in establishing these particular test outcomes as ground truth. The "ground truth" is that the device either met or did not meet the specified performance under test conditions.

4. Adjudication Method for the Test Set

Not applicable as an adjudication method for an AI algorithm test set. The compliance with standards and specifications is determined by direct measurement and observation of the device's performance during testing. This would be a Pass/Fail determination against the standard's criteria.

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. This is a hardware device (ventilator), not an AI/software device intended to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study is not relevant to this submission.

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

No, this is a physical medical device. It does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and performance specifications derived from recognized medical device standards (e.g., ASTM F 920-93, RTCA DO160D, MIL-STD 810F, IEC 529) and the manufacturer's own input requirements. The predicate device's performance also serves as a benchmark for comparison.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. As there is no AI algorithm requiring a training set, the concept of establishing ground truth for it is irrelevant in this context.

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The babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Testa, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).

The babyPAC ventilator consists of a control module with a disposable conventional Y patient circuit. The babyPAC ventilator is a pressure generator which depends solely on the pressure of the supply gas for its operation. The babyPAC 100 additionally incorporates an integrated electronic pressure alarm unit which becomes operational during Controlled Mandatory Ventilation. This unit provides a warning of significant changes which may occur in the patient's ventilation. Loss of battery power for the alarm is signaled to the user but will have no effect on the ventilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and performance on the babyPAC ventilator (K970158) already on the market.

The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator in ambulances and hospitals, and can be used in an MRI environment up to 3 Teslas. It is intended for transportation and for resuscitation of infants (above approx 11lb [5 kg]) and neonates up to 44 lb (20 kg).

The control module of the babyPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the controls for the gauge and internal pneumatics are recessed to minimise the possibilities of damage and inadvertent operation.

The babyPAC 100 portable ventilator consists of a control module and the following items: 22mm disposable Polyethylene respirator hose/ 22mm OD female connector and Paediatric 'Y' piece connector

The module weighs 8.25 lb (3.75 kilograms)

The module control panel has the following features:

• Adjustable Relief Pressure Control, range 12 to 80 cm H2O.
• Inspiratory Time Control, range 0.25 to 2.0 seconds.
• Expiratory Time Control, range 0.25 to 4.0 seconds
• Inspiratory Pressure Control, range 12 to 70 cm H2O, with click action warning at and above 40 cm H2O.
• PEEP/ CPAP Control, range 0 to 20 cm H2O with click action warning at and above 10 cm H2O.
• IMV Control, range Expiratory time 2.5 to 40 seconds with CPAP Pressure level and oxygen concentration as selected.
• Patient Inflation Pressure Manometer, range -10 to +100 cm H2O.
• Variable Oxygen Concentration, range 45 (approx) to 100% with oxygen only as supply, 21 to 70 % with oxygen and air supplies
• Supply Gas Failure Alarm indicators- One for air, the other for oxygen, these mechanically operated visual alarms give 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 to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a 'sample size' in terms of patient data or a specific number of devices tested for each parameter. The testing described is typically design verification and validation testing rather than a clinical trial with a patient test set.

• Test Set Sample Size: Not explicitly stated in terms of patient numbers or specific device units. The wording suggests testing of the ventilator's entire range and across its parameters.
• Data Provenance: The document does not specify the country of origin of the data. Given the "Submitter" and "Address" information (Smiths Medical International Ltd., UK), it is highly probable the testing was conducted in the UK or a region complying with the cited European standards (EN). The data is part of a submission for regulatory clearance (510(k)), implying it is prospective with respect to the regulatory approval process, but the detailed testing itself would have been retrospective if conducted on existing manufactured units as part of the product development lifecycle.

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

This type of information (experts for ground truth determination) is not applicable or provided in this document. The "ground truth" for the device's performance is established by direct measurement against engineering specifications and regulatory standards, not by expert consensus on clinical data. The tests refer to objective measurements (e.g., Tidal Volume, Frequency, alarm activation) against defined tolerances and compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation where adjudication would be necessary. Performance is measured against objective technical standards and predicate device performance.

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

No, an MRMC comparative effectiveness study was not done. This device is a ventilator, and the testing focuses on its engineering performance and safety compliance, not on human interpretation of medical images or data where MRMC studies are typically employed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The entire "Performance Data" section describes the device's performance in isolation (e.g., meeting EN standards, comparison of physical output parameters like tidal volume). The device itself is not an "algorithm" in the modern AI sense, but its functional performance was tested standalone without human intervention affecting the measurement of its core parameters. The electronic alarm unit's operation was also tested standalone in its comparison to the predicate.

7. Type of Ground Truth Used

The ground truth used is primarily based on:

• Engineering Specifications and Tolerances: For parameters like Tidal Volume, Frequency, Inspiration/Expiration times, relief pressure, PEEP/CPAP, etc.
• Regulatory and International Standards: E.g., EN794-3, EN60601-1, EN60601-1-2. Compliance with these standards forms the ground truth for safety and environmental performance.
• Predicate Device Performance: For demonstrating substantial equivalence, the performance of the babyPAC (K970158) and paraPAC 'medic' P200 (K020899) served as the established ground truth for comparison.

8. Sample Size for the Training Set

Not applicable. This device is a medical ventilator, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and validation are based on engineering principles and regulatory testing, not statistical learning from a dataset.

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

Not applicable, as there is no training set for this type of device.

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