(95 days)
The Respironics REMstar M-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. For use in the home or hospital/institutional environment.
The Respironics REMstar M-Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar M-Series Auto with AFLEX System also 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 an AFLEX therapy feature which provides added comfort for the user. As stated in the submission, the purpose of this modification is to provide enhanced event detection and algorithm response to these new event types. Like its predicate, this device 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 does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria with the requested level of detail. The document is a 510(k) summary for a CPAP system, primarily focusing on its substantial equivalence to a predicate device and its intended use.
However, based on the statement: "Design verification tests were performed on the Respironics REMstar M-Series Auto with AFLEX System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device." we can infer that acceptance criteria and verification tests were indeed conducted.
Given the available information, I can only provide a general interpretation based on the statements made:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify a table of acceptance criteria or numerical performance metrics for the device. The only performance-related statement is a general assertion that "All tests were verified to meet the required acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided in the document, as the "ground truth" concept as typically applied in AI/ML performance evaluation studies (e.g., expert consensus on medical images) is not relevant to this type of device modification submission.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied. The device is a CPAP system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
While "enhanced event detection and algorithm response" are mentioned as a purpose of modification, the document does not describe a standalone performance study with specific metrics, methodology, or results. The focus is on the device as a whole and its substantial equivalence to a predicate device, not on isolated algorithm performance.
7. Type of Ground Truth Used
Given that this is a CPAP device and the context of a 510(k) for a modified device, the "ground truth" would likely refer to objective engineering and clinical performance metrics measured against established standards and internal specifications, rather than expert consensus on diagnostic interpretations or pathology. Examples of such "ground truth" would be:
- Engineering Specifications: Pressure accuracy, flow rate, leak detection, alarm functionality, power consumption, sound levels.
- Clinical Performance (inferred): The device's ability to effectively deliver positive airway pressure for Obstructive Sleep Apnea, as measured through clinical trials or simulated use conditions against established physiological parameters.
- Risk Analysis Outcomes: Verification that identified risks are mitigated and safety requirements are met.
However, the document does not explicitly describe how this "ground truth" was established or measured with specific details.
8. Sample Size for the Training Set
This information is not provided. Given that the document refers to "design verification tests" and "risk analysis and product requirements" rather than an AI/ML development process, the concept of a "training set" in the context of machine learning is not directly applicable here. The device likely underwent traditional engineering design and testing, not a machine learning model training process that would require a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" with established ground truth in the AI/ML sense is not directly applicable to this document. The "ground truth" for verifying the device's performance (as inferred from point 7) would have been established through a combination of industry standards, regulatory requirements, internal design specifications, and potentially pre-clinical or clinical testing protocols for CPAP devices.
§ 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).