(112 days)
The REMstar Auto A-Flex HT 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 REMstar Auto A-Flex HT is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).
The REMstar Auto A-Flex HT delivers CPAP and Auto CPAP therapy. With CPAP therapy, the device provides a continuous positive airway pressure throughout the entire therapy session. With Auto CPAP therapy, the device provides a positive airway pressure that automatically adjusts to the patient's needs as various breathing events, such as apneas and hypopneas, are detected.
In addition to the CPAP and Auto CPAP therapy, the REMstar Auto A-Flex HT incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification. Two ramp options are available, ramp and GPAP, in which therapy pressure gradually increases (ramps) to the prescription pressure. The therapy pressure increases to the prescription pressure over minutes with the standard ramp feature and over days with the GPAP extended duration ramp feature. Humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask.
The REMstar Auto A-Flex HT is intended for use with a patient circuit that connects the device to a patient interface device (mask). A typical patient circuit consists of patient tubing (15mm, or heated tubing) and an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.
The provided text describes modifications to an existing device (REMstar Auto A-Flex HT) and seeks substantial equivalence to the predicate device (REMstar Auto A-Flex HT K113068). The submission focuses on non-clinical testing and standard compliance to demonstrate safety and effectiveness.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics for the modified device. Instead, it states:
| Acceptance Criteria (General Statement) | Reported Device Performance |
|---|---|
| Meet required acceptance criteria based on risk analysis and product requirements. | "All tests were verified to meet the required acceptance criteria." |
| Meet performance specifications. | "Results from the performance testing demonstrate that the REMstar Auto A-Flex HT meets its performance specifications..." |
| Raise no new issues of safety or effectiveness. | "...raises no new issues of safety or effectiveness..." |
| Substantially equivalent to predicate device. | "...is substantially equivalent to the identified predicate device." |
| Designed to meet requirements of FDA Recognized Consensus Standards. | The device meets the standards listed below (ISO 14971, ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 5356-1). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The testing described is non-clinical design verification testing, not clinical studies with patient test sets. Therefore, there is no mention of a "test set" in the context of patient data.
- Data Provenance: Not applicable. The testing is internal design verification rather than data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As described above, there was no clinical test set requiring expert ground truth establishment. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set to adjudicate.
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. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar Auto A-Flex HT." Therefore, no MRMC study was performed, and there is no mention of AI assistance or human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a CPAP system, not an AI algorithm. Its performance is assessed through its mechanical and functional operation, not as an algorithm, and it's designed for use by patients, not directly by "human-in-the-loop" readers in the context of image interpretation or similar AI applications.
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" would be the design specifications, performance requirements, and regulatory standards (e.g., ISO, IEC standards) that the device was tested against. The tests verified that the modifications did not alter the safety or effectiveness or the device's ability to meet these established engineering and regulatory benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware and software system, not an AI model requiring a training set in the machine learning sense. The "training set" equivalent here would be the accumulated engineering knowledge, design principles, and previous device iterations used in the development process, not a distinct dataset for algorithm training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set in the context of an AI algorithm. The "ground truth" for the device's development and verification is established through a combination of:
- Regulatory standards: As listed (e.g., ISO 14971, IEC 60601-1).
- Internal product requirements and specifications: Developed based on the intended use, risk analysis, and engineering principles.
- Performance of the predicate device: The modified device's performance is compared to its substantially equivalent predicate.
§ 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).