(175 days)
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.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).