(664 days)
The Panther 5 is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonates with Veight (VLBW)
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Panther 5" (Regulation Name: Continuous Ventilator). It discusses the regulatory process and general compliance requirements.
However, the document DOES NOT contain the specific information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, types of ground truth, or training set details.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about the study that proves the device meets the acceptance criteria from the given text.
The provided document is purely a regulatory clearance letter, not a clinical study report or a summary of performance data.
§ 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).