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The 840 Ventilator with Volume Ventilation Plus™ Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The 840 Ventilator with Neomode and Volume Ventilation Plus™ Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients with Ideal Body Weights (IBW) as low as 0.5kg, is intended to cover a variety of clinical conditions. The 840 Ventilatory with Neomode and Volume Ventilation Plus Options 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 VV+ modification provides the 840 Ventilator System with two new breath types, VC' and VS. The VV+ feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).

The provided document describes a 510(k) premarket notification for the 840 Ventilator System with Volume Ventilation Plus™ Option (VV+). However, it does not contain a table of acceptance criteria or a detailed study proving the device meets specific performance criteria outlined in the input request.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.

Here's an analysis of the information that is available in relation to your request:

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

• Not provided. The document does not define specific performance metrics or acceptance criteria (e.g., accuracy, precision, sensitivity, specificity for diagnostic devices) for the VV+ option. Instead, it asserts that "the technical characteristics of the device modification do not introduce new questions regarding safety or effectiveness of critical care ventilators" and that the device is "safe and effective for its intended use" based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not explicitly mentioned. While the document states that "Software design and development (including verification testing, test and software quality procedures) were conducted," it does not specify the sample size of any test sets or the provenance of data used in these tests. The focus is on the development process, not a clinical or performance study with a dedicated test set of patient data.

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):

• Not applicable/Not mentioned. Since no explicit "test set" and "ground truth" establishment are detailed in the context of a performance study, this information is not provided. The device is a ventilator with new breath types, not a diagnostic tool requiring expert interpretation of results.

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

• Not applicable/Not mentioned. No adjudication method is described as there's no mention of a diagnostic interpretation task requiring consensus among experts.

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 a diagnostic AI-assisted tool meant to be used by human readers for interpretation. 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:

• Not directly applicable. The device is an electro-mechanical ventilator with software-controlled breath types. Its "performance" would be assessed through engineering verification and validation testing, ensuring it delivers the intended ventilation parameters safely and accurately. The document states that "Software design and development (including verification testing, test and software quality procedures) were conducted," which implies standalone testing of the software's functionality, but no specific results or acceptance criteria for these tests are provided in the summary.

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

• Not explicitly defined in the context of a performance study. For a ventilator, "ground truth" would likely relate to objective physical measurements (e.g., delivered tidal volume, pressure, flow) against known standards or specifications, rather than clinical diagnoses or pathology. The document doesn't detail what specific "ground truth" was used for its verification testing.

8. The sample size for the training set:

• Not applicable/Not mentioned. This device is not an AI/ML device that requires a "training set" in the conventional sense. The software functionality for the new breath types is developed through traditional software engineering, programming, and testing.

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

• Not applicable/Not mentioned. As there is no "training set" for an AI/ML model, this information is not relevant.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of the 840 Ventilator System with the Volume Ventilation Plus™ Option to existing predicate devices based on intended use, materials, design, and adherence to software development guidelines. It does not present a detailed performance study with explicit acceptance criteria, sample sizes, or ground truth methodologies as would be expected for a diagnostic device or a new technology requiring such extensive clinical validation.

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The 700 Series Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions. It also has the capability to provide nebulization through use of an optional accessory, the EasyNeb Nebulizer.

The device is a low-cost, critical care ventilator intended to provide continuous ventilation for pediatric and adult patients, with the provision of nebulization functionality, through use of an optional accessory, the EasyNeb Nebulizer. The nebulization functionality is implemented by: a) modifying the 700 Series software to activate a nebulizer interface which directly controls the power and operation of the EasyNeb Nebulizer and b) the provision of an external nebulizer, the EasyNeb Nebulizer, as an optional accessory. which is intended to be used solely with the 740 and 760 ventilators. The modification to the ventilator is the activation through software of the nebulizer port on an existing Communications interface option. This nebulizer port facilitates electrical connection of the EasyNeb Nebulizer to the ventilator, the operation of which is controlled completely by ventilator software. The ventilator modification in essence then is a software modification which allows control of the nebulizer power on/off, the nebulization period and mode of operation. The EasyNeb Nebulizer is an ultrasonic nebulizer which is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data. It is powered and controlled by a 700 Series Ventilator, with the Communications Option installed. It contains a piezoelectric crystal that generates ultrasonic waves. The crystal's vibrations are transmitted through buffer water to a medication cup and convert the liquid medication into fine particles. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication.

This document describes the 700 Series Ventilator, which includes an optional EasyNeb Nebulizer accessory. The original text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for novel performance claims.

Based on the provided text, the device is a continuous ventilator intended for pediatric and adult patients. The key new feature is the nebulization functionality through the EasyNeb Nebulizer, which is controlled by modifications to the ventilator's software.

Here's an analysis of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific, quantifiable acceptance criteria or detailed reported device performance in a table format. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the device meets safety and effectiveness standards comparable to those already marketed.

Instead of performance metrics, the document highlights compliance with regulatory guidance and international standards for design, testing, and quality.

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify a sample size for any test set (e.g., for clinical trials or formal performance testing with human subjects or specific clinical data).

The term "test set" in the context of device performance usually refers to data used to evaluate a device's effectiveness. This 510(k) summary focuses on demonstrating equivalence through design, functionality descriptions, and compliance with standards rather than presenting results from a specific clinical performance test set.

Data provenance is also not mentioned.

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

This information is not provided in the document. Given the nature of a continuous ventilator and nebulizer (which are physical devices with mechanical and software functions), the "ground truth" for performance would likely come from instrumental measurements and technical testing to verify specifications, rather than expert consensus on interpretive data like medical imaging.

4. Adjudication Method for the Test Set

Since no specific test set or clinical evaluation requiring adjudication is described, an adjudication method is not mentioned.

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

An MRMC study is typically performed for interpretive medical devices (like imaging AI diagnostics) to compare the performance of human readers with and without AI assistance. The 700 Series Ventilator and EasyNeb Nebulizer are not interpretive devices in this sense. Therefore, an MRMC comparative effectiveness study was not conducted or mentioned in the provided text. No effect size for human readers improving with AI assistance is reported.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study. The "algorithm" here would refer to the ventilator's control software and the nebulizer's activation logic. The performance of these components is evaluated as part of the integrated device's overall functionality and compliance with standards, rather than as a separate "algorithm only" study as one might see for an AI diagnostic tool.

7. Type of Ground Truth Used

For a device like a ventilator and nebulizer, the "ground truth" would be established through:

• Engineering specifications and measurements: Verifying parameters like tidal volume delivery, breath rate, oxygen concentration, nebulization rate, power control, and timing.
• Compliance with recognized standards: Meeting the functional and safety requirements defined by standards like EN60601-1.
• Verification and validation testing: This would involve testing the software and hardware against design requirements to ensure it performs as intended.

The document generally refers to "combined testing and analysis of results" and "verification and validation testing" without specifying the exact nature of the "ground truth" for each test.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The 700 Series Ventilator is a rule-based or deterministic medical device, not an AI/machine learning system that requires a "training set" in the conventional sense. Its software controls are programmed based on engineering principles and medical requirements, not learned from data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

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