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The PMP4 Oxy Pro digital pulse oximeter system is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in different settings:
a) At hospitals, homes and alternate-sites as well as for EMS environment and for transport use.
b) At remote locations, where patients can obtain, display and transmit their pulse oximeter vital signs data to a medical expert via a communication device, such as a PDA or a remote server.
The PMP4 Oxy Pro is indicated for spot checking and/or continuous monitoring.

The PMP4 Oxy Pro is a photoelectric pulse oximeter device to be used for self testing upon prescription of an authorized health care provider. Specifically, it is designed for patients who wish to measure the oxygen saturation levels in the blood and pulse rate.
The PMP4 OxyPro is manually activated by the patient. It functions as a stand-alone device as patient can see "real time" data on its LCD. In addition, the PMP4 OxyPro enables transmission of real time data to the patient's PMP4 PDA or compatible generic PDA phone or personal computer supporting Bluetooth (BT) protocol.

The provided document does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria. The document is a 510(k) summary for the PMP4 Oxy Pro pulse oximeter, primarily focusing on its intended use, features, substantial equivalence to a predicate device (Nonin Avant® 4000), and compliance with various standards and regulations.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document indicates that "laboratory testing were conducted to verify and validate the PMP4 Oxy Pro compliance with all design specifications" and that "The device biocompatibility was evaluated and found to be satisfactory." However, it does not provide details about these tests, their methodology, or the specific performance metrics and acceptance criteria. The entire document supports the claim of substantial equivalence to the predicate device, the Nonin Avant® 4000, based on intended use and features.

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