(88 days)
The SG 066 and SG 067 Oxygen Enrichment Kits are designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
Oxygen Enrichment Kit
I apologize, but this document is a 510(k) clearance letter from the FDA for an "Oxygen Enrichment Kit" and does not contain the information requested in your prompt.
Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria.
- Information on sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- Details about the type or establishment of ground truth for a test or training set.
- Sample size for a training set.
This letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed technical and clinical study data you are asking for.
§ 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).