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The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

The Respironics BiPAP Synchrony 2 device is unchanged from K092043. The BiPAP Synchrony 2 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 therapy to 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 only change to the Respironics BiPAP Synchrony 2 device is to include the small size Respironics AF531 EE Leak 1 Full Face Mask (no built-in exhalation) and the small size Respironics AF531 EE Leak 2 Full Face Mask (with built-in exhalation) as options for use by its pediatric users. These two masks consist of a silicon cushion, polycarbonate faceplate, and an integrated entrainment valve elbow made of polycarbonate with a silicone flapper. All of the materials used within these masks are predicate materials. The small size Respironics AF531 EE Leak 1 Full Face Mask has an entrainment elbow with no additional exhalation and will require a separate exhalation device. Whereas, the small size Respironics AF531 EE Leak 2 Full Face Mask has an entrainment elbow with built-in exhalation, negating the need for a separate exhalation device. Both masks are designed to be used with either the four point style headgear or the capstrap style headgear, allowing the patient an option.

Anthropometric analysis was performed on the small size of the Respironics AF531 EE Leak 1 Full Face Mask and the small size Respironics AF531 EE Leak 2 Full Face Mask. This analysis has determined that these two small masks will appropriately fit the pediatric population (> 7 years of age, > 40 lbs).

The provided text describes a 510(k) premarket notification for the Respironics BiPAP Synchrony 2. The submission is to include two additional pediatric full face masks for use with the device. The core device (BiPAP Synchrony 2) itself is unchanged from a previously cleared device (K092043). Therefore, the study focuses on proving the compatibility and substantial equivalence of the new masks with the existing device.

Here's an breakdown of the acceptance criteria and the study as described:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated in terms of the number of masks or individual tests performed. However, "mask compatibility testing was performed with each mask" refers to the two new pediatric masks (AF531 EE Leak 1 and AF531 EE Leak 2). The "anthropometric analysis" was also performed on "the small size of both" masks.
• Data Provenance: Not specified (e.g., country of origin). The testing seems to be internal verification testing by the manufacturer, Respironics, Inc. It's an internal, prospective study to validate the new mask additions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is for compatibility of new accessories (masks) with an existing medical device. The "ground truth" for the performance criteria (pressure, waveform, etc.) would be established by engineering specifications and regulatory standards for ventilator performance, not by expert medical opinion in this context. The anthropometric analysis implicitly relies on expert knowledge of pediatric anthropometry, but no specific external experts are mentioned.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings (e.g., multiple readers interpreting images). The "verification testing" implies comparison against predefined acceptance criteria.

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

Not applicable. This is not an AI-based device or a diagnostic imaging study.

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

Not applicable. This is a medical device (ventilator and masks), not an algorithm.

7. The type of ground truth used

For Mask Compatibility: The ground truth would be established by predefined engineering specifications and regulatory standards for ventilator performance (e.g., specific pressure ranges, waveform characteristics, triggering sensitivity, alarm thresholds).

For Pediatric Fit: The ground truth is anthropometric data for the target pediatric population (> 7 years of age, > 40 lbs) coupled with design specifications for mask fit.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable.

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