(13 days)
The REMstar Pro with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Pro may be used in the home or hospital/institutional environment.
The Respironics REMstar Pro with C-Flex CPAP System is a microprocessor controlled blower based continuous positive pressure system. Respironics is adding an additional therapy feature to provide pressure relief during exhalation. The REMstar Pro with C-Flex CPAP 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.
The provided text describes a 510(k) submission for a modified CPAP system, the "Respironics REMstar Pro with C-Flex CPAP System". However, it does not contain specific acceptance criteria for performance metrics, nor details of a study proving the device meets distinct acceptance criteria beyond general design verification tests.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the modified device is as safe and effective as a previously cleared device. The key elements of the provided text that relate to your request are:
- Design verification tests were performed... All tests were verified to meet the required acceptance criteria. This statement confirms that an internal testing process occurred, but it doesn't specify what those acceptance criteria were, what constituted "design verification tests," or the results of those tests in detail.
Given the information provided, many of your requested points cannot be answered as they pertain to specific performance metrics and study details that are not present in this document.
Here's an attempt to answer your questions based only on the provided text, indicating where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Generic Statement) | Reported Device Performance (Generic Statement) |
|---|---|
| Required acceptance criteria | All tests were verified to meet the required acceptance criteria. |
- Specifics Missing: The document does not provide any specific quantitative or qualitative acceptance criteria (e.g., pressure accuracy within X mmHg, flow rate within Y L/min, noise level below Z dB). It only states that such criteria existed and were met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Missing: The document does not specify the sample size for any test set or the provenance of any data used for testing. The verification tests performed would likely involve bench testing of the device itself (hardware and software), rather than patient data in the context of substantial equivalence for a CPAP device.
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)
- Information Missing: This concept (experts establishing ground truth for a test set) is not relevant to the type of design verification described for this CPAP device. Ground truth is typically established for diagnostic or image-based AI devices. For a CPAP machine, "ground truth" would be related to its physical performance characteristics (e.g., actual pressure output) compared to its intended output, measured by calibrated instruments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Missing: Adjudication methods are typically relevant for complex clinical endpoints or subjective interpretations (e.g., image reading). This is not applicable to the design verification of a CPAP device's functional performance.
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
- Information Missing: An MRMC comparative effectiveness study is not mentioned because this device is a therapeutic (CPAP) device, not a diagnostic device heavily reliant on human interpretation of data where AI assistance would be a factor. The "C-Flex" feature is an enhanced therapy mode, not an AI diagnostic assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Missing: This question is not applicable. The device is a physical CPAP machine with an "enhanced therapy feature" (C-Flex). There is no "algorithm only" component that would perform a standalone diagnostic function separate from the human-in-the-loop operation of the CPAP machine by the patient. The C-Flex feature is integrated into the device's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Missing: As explained in point 3, the concept of "ground truth" in this context refers to the device's physical performance. For design verification tests, the ground truth would be established by reference to engineering specifications, calibrated measurement instruments, and potentially adherence to recognized standards (e.g., for pressure accuracy, flow, noise). The document does not elaborate on these specifics.
8. The sample size for the training set
- Information Missing: There is no mention of a "training set" because this device pre-dates the widespread application of machine learning/AI models that require such sets for their development. The "C-Flex" is described as an "additional therapy feature," implying a designed function rather than a learned algorithm based on a training set.
9. How the ground truth for the training set was established
- Information Missing: As above, the concept of a "training set" is not relevant to the information provided for this device.
Summary of what the document does provide:
- Device: Respironics REMstar Pro with C-Flex CPAP System.
- Intended Use: Treatment of adult Obstructive Sleep Apnea (OSA) only, in home or hospital/institutional environment.
- Modification: Addition of "an additional therapy feature to provide pressure relief during exhalation" (C-Flex).
- Study/Verification Type: Design verification tests were performed to ensure the modified device (including the C-Flex feature) met "required acceptance criteria."
- Conclusion: The manufacturer determined the modifications had no impact on safety and effectiveness, and the device is substantially equivalent to predicate devices. This implies that the design verification tests confirmed that the device, with its new feature, still operates within the safety and efficacy parameters of its predecessors.
§ 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).