(105 days)
The MAXO2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture. The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.
The MAXO2+ A(E) oxygen analyzer is a member of Maxtec's MAXO2 analyzer line of oxygen analyzers and monitors. It utilizes the MAX-250 oxygen sensor and is engineered for long life, maximum reliability and stable performance.
The provided documents (K040484) describe a 510(k) premarket notification for the MAXO2+ oxygen analyzer by Maxtec, Inc. The submission outlines the device's intended use and general characteristics but does not include details about specific acceptance criteria or a study proving that the device meets such criteria.
Therefore, based on the information provided, it is not possible to complete the requested table and answer the questions related to the device's acceptance criteria and performance study. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Caradyne - OxiCheck - K023565) rather than presenting a detailed performance study with acceptance criteria.
Missing Information:
The provided text does not contain any information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance studies.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion:
The provided 510(k) documents for the Maxtec MAXO2+ are primarily a regulatory submission demonstrating substantial equivalence. They do not contain the detailed technical validation study information that would be necessary to answer your specific questions regarding acceptance criteria, study design, and performance metrics.
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).