(203 days)
The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both invasive and non-invasive ventilation modes. The TV-100 is intended for use in hospital including intrahospital transport, pre-hospital, and air transport settings.
The TV-100 is designed to be a compact, lightweight, microprocessor controlled ventilator which allows for precise ventilatory control. The TV-100 features an internal compressor which allows the TV-100 to operate without the need for external pressurized gas supplies; however an external oxygen supply may be connected to blend with the air from the internal compressor. To further simplify use there are minimal ventilation controls. The TV-100 user interface (UI) is a touchscreen color LCD with full VGA resolution.
The TV-100 ventilator is a DC powered device operating on internal lithium ion batteries and powered by an external IEC 60601-1 compliant power supply. The external supply also charges the batteries.
Ventilation Modes include: A/C Mode (Assist/Control) CPAP Mode (Continuous Positive Airway Pressure) NIV Bilevel Mode (Non-invasive Ventilation) SIMV Mode (Synchronized Intermittent Mandatory Ventilation) PRVC Mode (Pressure Regulated Volume Control) Constant Flow Apnea Detection Standby Mode
The provided text describes the Bio-Med Devices TV-100, a continuous ventilator, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study that specifically proves the device meets those acceptance criteria in the context of an AI/ML algorithm or its performance characteristics typically assessed in such a study.
The document details non-clinical performance testing for various ventilator functions, comparisons to predicate devices, and a usability study, but these are not presented as "acceptance criteria" and "device performance" in the way one would define them for an AI/ML component. The document focuses on hardware functionality, safety standards compliance, and general performance, not an AI model's accuracy, precision, recall, or other statistical measures.
Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance for an AI/ML algorithm, nor can I provide information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details as these are not discussed in the provided text.
The text explicitly states:
"#### Clinical Testing Summary: No clinical testing was performed" (page 9), which further indicates that the type of study you are asking about, especially one involving ground truth and expert consensus for an AI/ML device, was not conducted or reported here.
The device itself is a continuous ventilator, and the document is a 510(k) summary for its premarket notification, indicating it is a traditional medical device, not specifically an AI/ML-powered device for which such metrics would be typically reported.
§ 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).