(72 days)
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:
- 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.
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No AI test set, no adjudication.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. No algorithm is being evaluated.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No ground truth for an AI.
- The sample size for the training set: Not present. No AI training set.
- How the ground truth for the training set was established: Not present. No AI training set.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).