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The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Synchrony may be used in the hospital or home.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

The Respironics BiPAP Synchrony with AVAPS is a microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support the patient resulting in improved patient comfort. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

The AVAPS feature is professionally selected and rides on top of the existing modality provided by the BiPAP Synchrony. The BiPAP Synchrony with AVAPS pressure control that contains various controls which are used to configure positive pressure therapies.

The BiPAP Synchrony with AVAPS is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

The BiPAP Synchrony with AVAPS Ventilatory Support System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases and a patient device (mask).

This submission describes the Respironics BiPAP Synchrony with AVAPS Ventilatory Support System, a continuous ventilator intended for non-invasive ventilatory support in adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The submission states that the device builds upon an existing cleared device platform, the Respironics BiPAP Synchrony (K992530, K012323, K020777).

1. Acceptance Criteria and Reported Device Performance:

The document mentions that "All tests were verified to meet the required acceptance criteria," but does not explicitly list the specific acceptance criteria or provide quantitative performance metrics. It generally states:

* The document states that bench testing included collecting this data for comparison and confirmed equivalence, implying these aspects met their respective (unspecified) acceptance criteria.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not specified for the clinical study. Bench testing details are also not quantified in terms of number of tests or samples.
• Data Provenance: The document does not specify the country of origin of the data. The clinical study is described as having been performed by Respironics, suggesting internal data. The nature of the study (clinical study and bench testing) suggests it could be prospective, but this is not explicitly stated.

3. Number and Qualifications of Experts for Ground Truth (Test Set):

Not applicable. The study primarily relies on comparing the AVAPS feature to existing therapy and comprehensive bench testing. There is no mention of experts establishing a "ground truth" in the diagnostic or interpretative sense for the test set. The clinical study aimed to establish therapeutic effectiveness.

4. Adjudication Method for Test Set:

Not applicable. There is no mention of an adjudication process as would be typical for studies involving human interpretation or subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document describes a clinical study to assure therapy provided with AVAPS was equivalent to or better than existing therapy provided without AVAPS. It does not describe an MRMC study comparing human readers with and without AI assistance. The device is a ventilatory support system, not an interpretive AI tool for imaging or diagnostics.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, in essence. The clinical study evaluated the effectiveness of the AVAPS feature as delivered by the device, independent of direct human intervention during the process of ventilation delivery itself. The bench testing also assessed the device's technical performance in a standalone manner. The device is controlled by a microprocessor and delivers therapy based on its internal algorithms.

7. Type of Ground Truth Used:

For the clinical study, the "ground truth" was likely clinical outcomes or measures of therapeutic effectiveness, as the study aimed to determine if AVAPS was "as effective as that of therapy without AVAPS." The specific metrics are not detailed, but would typically involve physiological parameters related to ventilation and patient well-being for OSA/Respiratory Insufficiency. For bench testing, the ground truth was derived from engineering specifications and performance expectations for waveform, triggering, and alarm data.

8. Sample Size for the Training Set:

Not applicable. The device is built on an existing platform and the AVAPS feature is an added functionality. There is no mention of a machine learning model that would require a distinct "training set" in the context of this submission. The device is stated to be microprocessor-controlled, but the development process doesn't explicitly refer to a machine learning training phase.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no explicitly defined "training set" in the context of this submission. The development of the AVAPS algorithm would have been based on physiological principles and engineering design, potentially informed by clinical expertise and data from previous device iterations or relevant medical literature.

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