(90 days)
The Anascient™ Breath Monitor is intended for use in clinical and research applications to measure oxygen uptake.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Invoy Technologies, LLC regarding their Anascient™ Breath Monitor. This letter primarily focuses on the FDA's decision of substantial equivalence and regulatory compliance and does not contain the detailed information necessary to fully answer the request about acceptance criteria and the study proving the device meets them.
Specifically, the document lacks the following crucial information:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, expert details, or adjudication methods for any study.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details about standalone algorithm performance studies.
- The type of ground truth used.
- Sample size and ground truth establishment for the training set.
The letter simply states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence decision is based on the information provided by the manufacturer in their 510(k) submission, which would have included performance data, but that specific data is not present in this FDA letter.
Therefore, I cannot provide a complete answer to your request based solely on the provided text.
§ 868.1730 Oxygen uptake computer.
(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).