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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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