(26 days)
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
- . Assist/Control (Pressure Controlled or Volume Controlled)
- SIMV (Pressure Controlled or Volume Controlled) ●
- CPAP/PSV
The iVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The iVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the iVent™ 201 Software.
I am sorry, but the provided text is a 510(k) premarket notification letter and summary for a medical device (iVent™ 201 Portable Ventilator). This document confirms the device's substantial equivalence to a legally marketed predicate device, but it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding AI algorithms, ground truth establishment, or human reader performance.
Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on:
- Confirming the device's regulatory classification and substantial equivalence.
- Listing predicate devices.
- Specifying indications for use.
- Detailing compliance with voluntary performance standards (e.g., ASTM, ISO, EN).
- Describing the device and its remote alarm adapter.
- Stating that safety and performance testing were conducted to determine substantial equivalence.
It does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for specific tests.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or AI-related performance.
- Standalone algorithm performance.
- Type of ground truth used for performance evaluation (beyond general safety and performance testing for regulatory submission).
- Sample size for a training set (as this is not an AI-enabled device validation).
- How ground truth for a training set was established.
§ 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).