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The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. For use in the home or hospital/institutional environment on adult patients.

The Respironics BiPAP Pro 2 Bi-level 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. The BiPAP Pro 2 Bi-level System also includes the flex therapy feature cleared in K032834 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. This clearance is seeking to extend the Bi-Flex range from 20 to 25 cmH2O maximum, to provide remote control of the device in a clinical setting and to allow viewing of compliance data by a physician/clinician. Like its predicates, the BiPAP Pro 2 Bi-level 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, an exhalation device, and a patient interface device.

This document is a 510(k) premarket notification for a modified medical device, the Respironics BiPAP Pro 2 Bi-level System with Bi-Flex. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or comprehensive performance studies.

Therefore, much of the requested information regarding detailed acceptance criteria, study sizes, expert qualifications, and the specifics of a comparative effectiveness study is not provided in this regulatory submission.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Design verification tests were performed on the Respironics BiPAP Pro 2 Bi-level System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, no specific acceptance criteria or the reported device performance for those criteria are detailed in the provided text. The submission focuses on the argument of substantial equivalence based on sameness with predicate devices and compliance with general standards.

2. Sample Size for the Test Set and Data Provenance

Not applicable/Not provided. The submission refers to "design verification tests" but does not describe the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for these tests. The focus is on verifying engineering requirements rather than a clinical trial-like test set.

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

Not applicable/Not provided. Clinical trials with expert-established ground truth for a test set are not described in this regulatory submission.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described. The submission is a 510(k) for a modified device, focusing on substantial equivalence, not a comparative effectiveness study showing improvement with AI assistance. The device also does not appear to incorporate AI.

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

No. This device is a hardware-based positive airway pressure system; it does not have a standalone "algorithm-only" performance that would typically be evaluated in such a study for software-as-a-medical-device (SaMD). The "design verification tests" would assess the integrated system's performance.

7. The Type of Ground Truth Used

The "ground truth" in the context of this submission refers to the engineering and performance specifications that the device was designed to meet, as verified by "design verification tests." The document states: "All tests were verified to meet the required acceptance criteria."

• For the "Intended Use" and "Features": The ground truth is established by the functional requirements of the device (e.g., delivering positive airway pressure, bi-level pressure, Bi-Flex feature up to 25 cmH2O, remote control, viewing compliance data). Compliance with these features is assessed through engineering tests.
• For "Safety and Effectiveness": The ground truth is compliance with applicable standards (e.g., 21 CFR 868.5905, Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 1998) and demonstration of substantial equivalence to predicate devices, implying similar safety and effectiveness profiles.

8. Sample Size for the Training Set

Not applicable/Not provided. This device is not described as using machine learning or AI that would require a "training set" in the conventional sense. The "design verification tests" are for validating the product's engineering and performance against requirements.

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

Not applicable/Not provided, as there is no mention of a training set for an AI/ML algorithm. The "ground truth" for the device's design and testing would be based on engineering specifications and regulatory standards.

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The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only.

The Respironics BiPAP Pro 2 Bi-level 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. The BiPAP Pro 2 Bi-level System also includes the flex therapy feature cleared in K011714 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicates, the BiPAP Pro 2 Bi-level 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, an exhalation device, and a patient interface device.

The provided text describes a 510(k) premarket notification for the Respironics BiPAP Pro 2 Bi-level System. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices. It focuses on demonstrating equivalence rather than proving novel efficacy through extensive clinical studies.

Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not directly applicable or explicitly detailed in this type of regulatory document. The submission primarily relies on design verification tests demonstrating that the modified device meets its own product requirements and assumed equivalence to predicate devices, rather than a quantifiable study proving specific clinical performance against acceptance criteria in the way a new AI-powered diagnostic might.

Here's a breakdown based on the available information:

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

The document states: "Design verification tests were performed on the Respironics BiPAP Pro 2 Bi-level 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" (e.g., pressure accuracy within X mmHg, flow rate within Y L/min, noise levels below Z dB) and the reported numerical performance against those criteria are not provided in this summary. The statement indicates that these criteria were met, but does not detail them.

2. Sample size 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 "design verification tests" are typically engineering and functional tests on the device itself, not a clinical study on a patient population with a "test set" in the context of AI/diagnostic performance.

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 or provided. Ground truth in this context (a BiPAP machine) would likely refer to engineering specifications and performance standards, not expert clinical diagnosis.

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

This information is not applicable or provided. Adjudication methods are typically used in clinical trials or studies where there is subjective interpretation of data, which is not the primary focus of this device's regulatory 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 or provided. The device is a BiPAP machine, not an AI-assisted diagnostic tool.

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

This information is not applicable or provided. The device is a therapeutic BiPAP machine, not a standalone diagnostic algorithm.

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

The "ground truth" for this device's performance would be against its engineering specifications and functional requirements (e.g., delivering specific pressure levels, maintaining certain flow rates, safety standards). This is not explicitly detailed beyond the statement that "All tests were verified to meet the required acceptance criteria."

8. The sample size for the training set

This information is not applicable or provided. The device is a hardware-based medical device, not an AI model trained on a dataset.

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

This information is not applicable or provided. See point 8.

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