(232 days)
The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults and paediatrics. Intended areas of use: · In the intensive care ward or in the recovery room. · During transfer of ventilated patients within the hospital. The HAMILTON-C2 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
Not Found
I apologize, but the provided text does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device.
The document is an FDA 510(k) clearance letter for the HAMILTON-C2 ventilator, indicating that the device has been found substantially equivalent to a predicate device. It specifies the intended use and regulatory information but does not detail the testing or studies performed to demonstrate performance against specific acceptance criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Information on the number or qualifications of experts for ground truth.
- Details on adjudication methods.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Details on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample sizes for training sets.
- How ground truth for training sets 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).