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The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital/institutional environment.

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

The Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex is a microprocessor controlled blower based bi-level positive pressure system that delivers two different 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. Respironics is adding an additional therapy feature to the existing Spontaneous "S" mode in the BiPAP Synchrony Ventilatory Support System Software. This feature will ease the transition from the end of inspiration to the beginning of exhalation. The BiPAP Synchrony Ventilatory Support System with Bi-Flex 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 interface device.

The provided document is a 510(k) premarket notification for a medical device (Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex). It focuses on demonstrating substantial equivalence to a predicate device and does not contain the kind of detailed performance study information typically required for characterizing acceptance criteria, sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, and sample sizes for training/test sets cannot be extracted from this document.

Here's what can be gathered:

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

The document states: "Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, the specific acceptance criteria (e.g., specific pressure ranges, flow rates, response times) and the reported device performance against these criteria are not detailed in this submission. This document summarizes that tests were conducted and criteria were met, but it doesn't provide the criteria or performance data itself.

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

This information is not provided in the document. The submission pertains to design verification, which typically involves engineering tests, not clinical data sets in the way an AI/ML study would.

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 information is not applicable/provided. The device is a ventilatory support system, not an interpretive device that requires expert-established ground truth in the context of diagnostic performance studies.

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

This information is not applicable/provided. Adjudication methods are typically relevant for establishing ground truth in diagnostic studies, which is not the primary focus of this submission.

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 information is not applicable/provided. This device is a ventilatory support system, not an AI-assisted diagnostic tool that would involve human readers.

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

This information is not applicable/provided. The device's performance relates to its mechanical and software functions to deliver ventilation, not an "algorithm only" performance in the context of an AI/ML model.

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

This is not explicitly stated in the document, as the "ground truth" concept in this context would likely refer to engineering specifications and physical measurements, rather than clinical outcomes or expert consensus on diagnoses. The document mentions "risk analysis and product requirements" as the basis for design verification.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI/ML product developed using training sets in the typical sense.

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

This information is not applicable/provided.

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The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. 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 Ventilatory Support System is a microprocessor controlled blower based Bi-level positive pressure system that delivers two different 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. Respironics is modifying the existing device with the addition of 3 alarms, expanding the EPAP setting to 30 cmH2O and adding a remote control accessory for use in a clinical setting. The BiPAP Synchrony 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 interface device.

This 510(k) submission (K012323) is for a modification to the Respironics BiPAP Synchrony Ventilatory Support System, specifically adding 3 alarms, expanding the EPAP setting to 30 cmH2O, and adding a remote control accessory. It is a modification to an existing device, not a new device requiring extensive clinical studies with human readers or AI.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, the specific acceptance criteria and the detailed performance results (e.g., alarm thresholds, EPAP accuracy, remote control reliability) are NOT explicitly provided in the public summary. The 510(k) summary typically contains a high-level overview. Detailed test reports would be part of the full 510(k) submission, which is not publicly released in its entirety.

Table Placeholder (based on general understanding of device modifications):

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

The document does not specify the sample size for the test set or the data provenance. Design verification tests generally involve testing multiple units of the modified device. Given this is a device modification (not a clinical study of diagnostic accuracy), the "test set" would refer to the units of the device being tested, not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this 510(k) submission as it describes a modification to a medical device's hardware/software features, not a diagnostic or prognostic algorithm that requires expert consensus on ground truth from clinical data. The "ground truth" for this type of submission is defined by engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical data, where there might be disagreement among experts. For device design verification, a pass/fail criterion based on pre-defined specifications is typical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is about a device modification, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No, a standalone (algorithm only) performance study was not done. This concept is for AI algorithms separate from a human operator. The modifications here are integrated features of the BiPAP Synchrony device.

7. The Type of Ground Truth Used:

The ground truth used for these design verification tests would be engineering specifications and performance requirements for the alarms, EPAP delivery, and remote control functionality, as well as adherence to relevant regulatory standards (e.g., for safety, EMC). It is not clinical ground truth like pathology, expert consensus on images, or outcomes data, as this is not a diagnostic or treatment outcome study.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) describes a traditional medical device modification, not an AI/ML-driven device that requires a training set.

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

This information is not applicable for the same reasons as #8.

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