(90 days)
The Respironics Q Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.
The Respironics REMstar Q Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Q Series Auto with AFLEX CPAP System includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition, the device includes the AFLEX therapy feature which provides added comfort for the user (also cleared in K063830). Like its predicate, the REMstar Q Series Auto with AFLEX 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 19mm tubing, an exhalation device, and a patient interface device.
This submission describes a 510(k) premarket notification for a modified CPAP system, not a study evaluating a novel device against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted directly from the provided text.
Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device due to a "modified design." The core statement regarding performance is:
"Design verification tests were performed on the Respironics REMstar Q-Series Auto with AFLEX CPAP 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, the detailed results, and the study design that "proves" the device meets these criteria are not provided in the given document. The document only states that such tests were performed and met the criteria.
Therefore, I cannot populate the table or provide detailed answers to questions 2 through 9 for a specific performance study.
Here's an attempt to address your request based on the limited information available and acknowledging what is not present:
Section 1: A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific acceptance criteria are not detailed in this document. It's broadly stated that tests were performed based on risk analysis and product requirements. | "All tests were verified to meet the required acceptance criteria." |
Section 2: Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the document.
- Data provenance: Not specified in the document. The tests performed are "design verification tests," which are typically laboratory-based and prospective, but no details are provided.
Section 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)
- Number of experts: Not applicable/not specified. Design verification tests for a CPAP system would typically involve engineering and possibly clinical experts for test protocol development and data interpretation, but the document does not detail this. The "ground truth" for these tests would likely be established by engineering specifications and industry standards rather than expert consensus on patient data.
Section 4: Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/not specified. The document describes engineering design verification, not a clinical study requiring adjudication of expert opinions.
Section 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
- MRMC study: No, an MRMC comparative effectiveness study was not done. This is a medical device, specifically a CPAP system, not an AI diagnostic tool.
Section 6: If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study: No, this is not an AI algorithm. The device's performance is inherent to its mechanical and software functions. The document refers to "design verification tests" for the device as a whole.
Section 7: The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: The "ground truth" for the design verification tests would be established by
- Engineering specifications and performance requirements derived from risk analysis.
- Applicable standards (e.g., electrical safety, biocompatibility, performance standards for CPAP devices).
These are not equivalent to expert consensus on clinical cases or pathology.
Section 8: The sample size for the training set
- Sample size for the training set: Not applicable. This document does not describe the development of an AI model with a training set.
Section 9: How the ground truth for the training set was established
- Ground truth for the training set: Not applicable. As this is not an AI model, there is no training set or associated ground truth.
§ 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).