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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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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 K063533/K071509. The only change is to include the Respironics Performax Youth EE mask as a 3rd option for use by its pediatric users. This mask is the same mask design as is used by the small size of the cleared Respironics Performax Total Face Mask (K072592). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Performax Youth EE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.

The provided text is a 510(k) summary for a medical device called BiPAP Synchrony 2. This submission focuses on adding a new pediatric mask (Respironics Performax Youth EE mask) for use with an already cleared device. Therefore, the "acceptance criteria" and "device performance" discussed relate specifically to the compatibility and safety of this new mask with the existing ventilator system, rather than the core performance of the ventilator itself.

Here's an analysis based on the provided information, addressing your numbered points:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the mask compatibility testing. It simply states that "mask compatibility testing was performed." It also does not provide details on the data provenance such as the country of origin or if the testing was retrospective or prospective. It is implied that the testing was performed by Respironics, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable. The study described is an engineering and functional compatibility test of a medical device accessory, not a study requiring expert consensus for ground truth on clinical outcomes or diagnoses. The "ground truth" here is the pass/fail against predetermined engineering and performance specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as the study involves objective engineering measurements against defined performance criteria. There's no mention of a human adjudication process for the test results.

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

This is not applicable. This submission is for a ventilator and mask accessory, not an AI-powered diagnostic or assistive technology where a MRMC study would be relevant.

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

This is not applicable. The device is a ventilator, a mechanical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this compatibility study was based on pre-defined engineering and performance specifications for the ventilator system and the new mask, as well as the safety and effectiveness requirements for medical devices. The objective was to confirm that the new mask did not negatively impact the existing cleared device's performance characteristics.

8. The sample size for the training set

This is not applicable. The submission describes a device modification and compatibility testing, not a machine learning model that would require a training set.

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

This is not applicable, as there is no training set for a machine learning model discussed in this document.

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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 K063533. The only change is to include a Respironics pediatric mask as a second option for use by its pediatric users. This mask is the same mask design as is used by the cleared Respironics Reusable Contour Deluxe Nask (K991648). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Pediatric Mask matches that of the Resmed Kidsta previously cleared in K063533.

This document describes a 510(k) premarket notification for the BiPAP Synchrony 2 Ventilatory Support System with the addition of a Respironics pediatric mask. The core device itself (BiPAP Synchrony 2) is unchanged from a previously cleared predicate device (K063533). The submission specifically addresses the compatibility of the new pediatric mask.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criteria and performance are reported qualitatively in the document. No specific numerical thresholds are provided, as the study focused on compatibility and function rather than a new "performance metric."

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "mask compatibility testing" but does not detail the number of masks, devices, or test subjects used in this testing.
• Data Provenance: Not explicitly stated, however, the testing was performed by Respironics, Inc. and is part of a submission to the FDA in the United States. It's likely a controlled, in-house laboratory study. It would be considered prospective for the specific purpose of this submission (testing the new mask's compatibility).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The testing was conducted by the manufacturer, Respironics, likely by their engineering and R&D teams.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/specified. The testing described appears to be objective, functional performance testing (e.g., pressure, waveform analysis, discrete function activation) rather than subjective expert assessment. There is no indication of multiple readers or an adjudication process for these technical tests.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on the compatibility of a new mask with an existing device, involving technical performance testing, not the clinical effectiveness or human-in-the-loop performance with or without AI.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone performance study in the context of an algorithm or AI was not done. This device is a ventilatory support system, not an AI/algorithm-based diagnostic or therapeutic device.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this testing was based on pre-defined engineering specifications and performance requirements for the ventilatory support system. The "acceptance criteria" for the mask compatibility testing (pressure, waveform, triggering, cycling, alarm functionality) refer to these established technical standards for proper device function.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This submission concerns a physical medical device and mask, not an AI or machine learning algorithm that would require a 'training set.'

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

• Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

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