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The Oximetry Module can be used with Philips Respironics BiPAP C Series (BiPAP AVAPS and BiPAP S/T) ventilators to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate for adult and pediatric patients. The Oximetry module may be used in a hospital or home care environment.

The Philips Respironics BiPAP C-Series Ventilatory System (BiPAP AVAPS and BiPAP S/T) is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of ages; > 18 kg) patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C-Series Ventilatory Support System may be used in the hospital or home.

The Respironics BiPAP C-Series (BiPAP AVAPS and BiPAP S/T) Ventilatory Support Devices when used with the Respironics Link Module Oximetry Interface Kit provides access to patient therapy information through the two-way transfer of data between patient devices and clinicians through the appropriate software including therapy efficacy and device settings as requested by the attending physician.

The Oximetry Interface Kit consists of the following components:

• Respironics Link Module
• SD Card and Mailer
• Masimo Oximetry Module and Sensor

When connected to the flow generator, the oximetry module records treatment and pulse oximetry data during therapy. The data is stored on a secure digital card. After treatment, the secure digital card containing the data can be removed from the device and sent to the clinician for review.

The Respironics BiPAP C-Series (BIPAP AVAPS and BiPAP S/T) devices, cleared under K092818, when used with the Respironics Oximetry Interface Kit are microprocessor controlled blower based positive pressure systems that interface with an with integrated heated humidifier, like the predicate cleared in K102465.

I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance tables, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document describes a 510(k) submission for a medical device (Respironics BiPAP Ventilator Series Oximetry Interface Kit) and focuses on administrative information, intended use, device description, non-clinical testing, and a statement of safety and effectiveness, mostly comparing it to predicate devices.

The "Test Execution Summary" section mentions several tests (Time Meters, Standard Regression Test, Pulse Oximetry User Interface, Pulse Oximetry Logging, Serial Port AutoBaud Detection, User Interface – Monitor Parameters Submenu) and states that "All tests have passed and requirements referenced in these tests have been verified," and "All tests were verified to meet the required acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. It also does not delve into the methodology of studies with details like sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or how ground truth was established for training sets, which are usually part of more comprehensive study reports rather than a 510(k) summary.

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