(88 days)
Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.
The Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards. The device is intended for use by trained healthcare professionals, i.e. doctors, nurses, technicians, respiratory therapists, paramedics.
The device is intended for mobile use for emergency medical care or primary care of emergency patients:
- During transport in emergency rescue vehicles or aircrafts including helicopters .
. In accident and emergency departments, in the recovery room.
Mobile use for secondary transfers:
- During transfer by road or air '
- l When moving ventilated patients around in the hospital.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study proving the device meets them.
The document is a 510(k) summary for the Dräger Oxylog 3000 ventilator. It mentions "Summary of Performance Testing" and states:
- "Safety testing was conducted per IEC60601-1, IEC60601-1-2 and other applicable standards with respect to mechanical, electrical and biocompatibility."
- "The results of all verification and validation testing demonstrate that all system and design requirements for the Oxylog 3000 device have been met."
- "Qualification included hazard analysis, system level qualification and verification / validation tests."
However, it does not provide:
- A table of specific acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts or their qualifications.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Results of standalone (algorithm only) performance.
- The type of ground truth used for performance studies.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on establishing substantial equivalence to predicate devices and adherence to general safety standards, rather than detailing specific performance studies with acceptance criteria or ground truth analysis as you've requested.
§ 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).