(83 days)
The BiPAP Auto delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. The device is for use in the home or hospital/institutional environment on adult patients.
The Respironics BiPAP Auto 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. Two modes are being introduced, which include the Auto Bi-Level mode and Split Night Auto Bi-Level mode. Bi-Level therapy with automatically adjusting IPAP and EPAP levels is delivered in the Auto Bi-Level mode. The Split Night Auto Bi-Level mode limits the pressure during the first portion of the night to allow diagnostic recording; thereafter the pressure responds to the patient's needs to provide an assessment of therapeutic requirements. Pressure relief upon exhalation (Bi-Flex feature) may be enabled during Auto Bi-Level therapy.
The BiPAP Auto 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.
Here's a breakdown of the acceptance criteria and study information for the BiPAP Auto device, based on the provided text:
Acceptance Criteria and Device Performance
The provided document primarily focuses on establishing "substantial equivalence" to predicate devices rather than setting explicit quantifiable acceptance criteria against specific performance metrics for the new Auto Bi-Level and Split Night Auto Bi-Level modes. However, the document does outline the clinical efficacy criteria for the Auto Bi-Level mode.
| Acceptance Criteria (for Clinical Efficacy) | Reported Device Performance |
|---|---|
| Primary: As effective at determining optimal pressures as manually titrated, bi-level positive airway pressure. | Demonstrated (Clinical Efficacy Study) |
| Secondary: Maintain lower average treatment pressures (average IPAP and average EPAP) as compared to manually titrated fixed pressure bi-level therapy. | Demonstrated (Clinical Efficacy Study) |
| Secondary: AHI (Apnea-Hypopnea Index) will remain below 10 during polysomnography. | Demonstrated (Clinical Efficacy Study) |
Note: The document states that the "Clinical Efficacy Study; demonstrated that the Auto Bi-Level Mode (auto-adjusting bi-level positive airway pressure) of the BiPAP Auto device is as effective at determining optimal pressures as manually titrated, bi-level positive airway pressure," and that "The following performance indicators additionally demonstrate the clinical efficacy of the Auto Bi-Level therapy: Auto Bi-Level therapy maintains lower average treatment pressures (as defined by average IPAP and average EPAP as compared to manually titrated fixed pressure bi-level therapy), and the AHI will remain below 10 during polysomnography." This indicates that all these criteria were met.
Study Information
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). It simply refers to a "Clinical Efficacy Study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The clinical efficacy study compares the device's auto-adjusted pressures to "manually titrated, bi-level positive airway pressure." The manual titration itself implies expert involvement, but the number and qualifications of those experts are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood for human readers interacting with AI was not described. The study was a "Clinical Efficacy Study" comparing the device's auto-adjusting mode to manually titrated therapy. This is a comparison between an automated therapy mode and a traditional manual therapy, not a study of human readers assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the "Bench Testing BiPAP Auto vs. REMstar Auto with C-Flex" assessed the event detection and control capability of the BiPAP Auto. This would be a standalone evaluation of the algorithm's performance in a controlled environment.
- The "Clinical Efficacy Study" also assessed the Auto Bi-Level Mode which is an algorithm-driven therapy, comparing its effectiveness against manual titration. While patients are involved, the core evaluation is of the algorithm's ability to determine optimal pressures and maintain AHI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Clinical Efficacy Study," the "ground truth" or comparator for optimal pressure determination was "manually titrated, bi-level positive airway pressure." This implies expert-driven titration. The AHI remaining below 10 during polysomnography suggests polysomnography results were used as an objective measure.
8. The sample size for the training set:
- This information is not provided in the document. The device's "Auto therapy algorithm" was added, and it's stated that the "Split Night mode (split night study feature) is based on the Split Night Auto CPAP mode (split night study feature) currently cleared by the FDA in K041010 (REMstar Auto with C-Flex CPAP System)." This suggests prior development and possibly training from the predicate REMstar Auto.
9. How the ground truth for the training set was established:
- This information is not provided in the document. Given that the algorithm and features are adapted from the predicate device (REMstar Auto with C-Flex), the training and ground truth establishment would likely have occurred during the development of that earlier device. The submission focuses on the modifications and equivalence.
§ 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).