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The 840 Ventilator System with Expanded NeoMode Option provides continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option, is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg and for use in a wide variety of clinical conditions.

The 840 Ventilator System with Expanded NeoMode Option is intended for use in hospitals and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The PB 840 Ventilator is a dual-microprocessor-based, touch-screen controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult patients (with expanded NeoMode Option) or infant to adult patients (with no Option) who require either invasive ventilation or non-invasive ventilation.

The 840 Ventilator Expanded Neomode Option includes the software enhancements that lower the ideal body weight (IBW) from 0.5kg to 0.3kg and provides the user an option to lower the tidal volume to 2mL. The ventilator determines values for operational variables and allowable settings based on breathing circuit type and IBW. The software controls prevent inadvertent mismatching of patient size and breathing circuit type.

The 840 Ventilator Expanded Neomode Option is available as an integrated part of the 840 Ventilator or as separate software upgrade kit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 840 Ventilator System with Expanded NeoMode Option:

It's important to note that this document is a 510(k) summary for a ventilator, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI device studies (like MRMC, number of experts for ground truth, sample sizes for test/training sets in the context of image analysis or similar AI tasks) are not applicable here. The "device" in this context is a medical hardware and software system, and the "study" refers to engineering verification and validation testing, not clinical trials in the way AI diagnostics are evaluated.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to a medical device modification, not an AI study)

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for the test set in terms of patient data or clinical cases. The testing described is primarily engineering verification and validation of software and hardware performance against specifications. These tests would involve various simulations, bench testing, and potentially some animal or human user testing, but not a "test set" in the sense of a dataset for an AI algorithm.
   • Data provenance: Not applicable in the context of a typical "AI study." The context here is product development and regulatory submission for a physical medical device with software components.

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

   • This is not applicable for this type of device submission. Ground truth for a ventilator's performance is established by engineering specifications, regulatory standards (like FDA guidances for ventilators), and physiological principles, not by expert consensus on a test set of data points in the same way it would be for an AI diagnostic. The "experts" would be the engineers and compliance officers designing and testing the device, ensuring it meets these established criteria.

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

   • This is not applicable. Adjudication methods like 2+1 are typically used in clinical studies or for establishing ground truth from multiple human readers in an AI development context. For a ventilator, performance is objectively measured against predefined engineering and regulatory specifications.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specific to AI systems that assist human readers (e.g., radiologists interpreting images). The 840 Ventilator is a life-support device, and its expanded NeoMode option is a software enhancement to its functionality, not an AI-assisted diagnostic tool.

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

   • The device's core functionality is a "standalone" system in that it delivers ventilation based on its internal algorithms and control systems. However, this is not an "AI algorithm only" in the sense of an AI diagnostic that might be compared to human performance. The ventilator's performance was validated, which inherently evaluates its "standalone" function in delivering breaths.

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

   • The "ground truth" for this device's performance is based on engineering specifications, established physiological parameters for ventilation, and regulatory guidance documents (e.g., "FDA Draft Reviewer Guidance for Ventilators"). These define the acceptable ranges and accuracy for breath delivery, tidal volume, and other operational variables.

7. The sample size for the training set:

   • This is not applicable as the document describes a software upgrade for an existing medical device, not the development of a machine learning model where a "training set" would be used to teach an algorithm. The software was developed and then validated against specifications.

8. How the ground truth for the training set was established:

   • Not applicable for the reasons stated above.

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