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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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The Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an monitoring of tansitional Drygol and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo Disposable Ear Oximetry Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:

• · Masimo SET technology
• · Masimo Rainbow SET technology
  The E1 Sensors and the predicates (K012992) Masimo Reuseable Ear Sensor (LNOP Sensor) and (K051212) the LNCS Reusable Ear Sensor (LNCS Sensor) have similar indications for use/ intended use. The main difference is that the E1 Sensors are disposable ear sensors.

Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Masimo Disposable Oximetry Ear Sensors:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance Testing" was applied to the development of the E1 Sensors and that "The E1 Sensors have been validated to the Masimo SET Technology."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes a sensor for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate). This is a direct measurement device and not an AI-assisted diagnostic tool that would involve "human readers" or an MRMC study in the context of improving human interpretation. Therefore, an MRMC comparative effectiveness study was not applicable and not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was done. The "Specifications" section directly lists the accuracy of the E1 Sensors for SpO2 and Pulse Rate measurements, which are inherent performance characteristics of the device itself, independent of human interpretation or intervention during measurement. The validation was against "Masimo SET Technology," implying a direct comparison to an established measurement standard rather than human-in-the-loop performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document implies the ground truth for performance validation was likely established through comparison with Masimo SET Technology, which itself would be validated against a recognized gold standard for oxygen saturation and pulse rate measurement (e.g., blood gas analysis for SpO2). However, the specific method for establishing this ground truth (e.g., clinical study with arterial blood gas draws) is not detailed in this summary.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as this device is a sensor for direct measurement and not a machine learning algorithm that typically requires a distinct training phase. The validation stated is against "Masimo SET Technology."

9. How the Ground Truth for the Training Set was Established

As noted in point 8, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device based on the provided information. The device's performance is validated against an established technology (Masimo SET Technology), which would have its own validated ground truth.

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