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The e360 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility,

The Newport e360. Ventilator is a pneumatically powered, microprocessor controlled ventilator. Performance characteristics and clinical féatures support infant/pediatric (≥20 mL) through adult patients. Front panel controls allow trained operators to select ventilation controls for volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes. A comprehensive alarm system is built-in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides approximately 45 minutes of power. The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995). The alarms of the e360 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).

The provided text is a 510(k) summary for the Newport e360™ Ventilator and does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

The document describes a conventional medical device (a ventilator) and its submission for 510(k) clearance by the FDA. The "study" mentioned is a series of nonclinical tests to verify changes to the ventilator, not a study evaluating an AI algorithm's performance against acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Here's why each point cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory clearance for a ventilator, not performance metrics of an AI.
2. Sample size used for the test set and the data provenance: Not present. The "tests" refer to nonclinical verification of engineering changes to the ventilator, not a test set for an AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment for an AI is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No AI test set, no adjudication.
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 present. This document is not about an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. No algorithm is being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No ground truth for an AI.
8. The sample size for the training set: Not present. No AI training set.
9. How the ground truth for the training set was established: Not present. No AI training set.

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The e360 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility

The Newport e360 Ventilator is a pneumatically powered, microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (≥20 mL) through adult patients. Front panel controls allow trained operators to select ventilation controls for volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes. A comprehensive alarm system is built- in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides approximately 45 minutes of power. The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995). The alarms of the e360 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).

This document is a 510(k) summary for the Newport e360 Ventilator. The information provided focuses on the device's description, intended use, and general testing, rather than a detailed study proving performance against specific acceptance criteria in a clinical context. Therefore, many of the requested categories about clinical study design and outcomes cannot be fully addressed from this document.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "Comprehensive verification and validation testing was performed with the Newport e360 Ventilators including; hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. All test results met pre-defined acceptance criteria." However, it does not provide specific numerical or qualitative acceptance criteria for these categories, nor does it detail the specific performance results for each. It only states that the criteria were met. The alarm system's performance is specifically mentioned as meeting or exceeding critical care ventilator standards and FDA guidance.

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

• Sample Size for Test Set: Not specified in this document. The testing described is verification and validation, which often involves engineering and regulatory tests, not necessarily a "test set" in the context of clinical data for AI/ML performance.
• Data Provenance: Not applicable. This document describes testing for a ventilator device, not an AI/ML algorithm that relies on patient data for its performance validation.

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

• Not applicable. This is not a study involving expert-established ground truth from clinical data. The "ground truth" for a ventilator's performance is typically defined by engineering specifications, regulatory standards, and physical measurements.

4. Adjudication method for the test set

• Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes.

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 document describes a medical device (ventilator) and its engineering-based verification and validation, not an AI-assisted diagnostic or interpretive system that would be subject to an MRMC study.

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

• Not applicable. This is not a study of an algorithm.

7. The type of ground truth used

• The "ground truth" for the device's performance would be based on:
  • Engineering Specifications: Designed performance parameters.
  • Regulatory Standards: Compliance with FDA Draft Reviewer Guidance for Ventilators (1995) and other relevant industry standards for medical devices (e.g., electrical safety, EMC).
  • Physical Measurements and Testing: Verification of output pressures, volumes, modes, alarm thresholds, etc., using specialized equipment.

8. The sample size for the training set

• Not applicable. This is not an AI/ML system requiring a training set from data.

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

• Not applicable.

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