Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device