(73 days)
The Respironics REMstar Auto M-Series 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 Auto M-Series with AFLEX CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Auto M-Series with AFLEX CPAP System also includes the auto mode and the flex therapy feature cleared in K040101 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the REMstar Auto M-Series with AFLEX device includes a Auto CPAP with AFLEX mode which provides added comfort for the user. Like its predicates, the REMstar Auto M-Series 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 22mm tubing, an exhalation device, and a patient interface device.
The provided document is a 510(k) summary for the Respironics REMstar Auto M-Series with AFLEX CPAP System. It states that "Design verification tests were performed... All tests were verified to meet the required acceptance criteria." However, it does not explicitly detail the acceptance criteria or the specific results of those tests. It is a declaration of substantial equivalence based on the device meeting its design requirements, but the specifics of those requirements are not provided in this public summary.
Therefore, many of the requested details about acceptance criteria, study design, and results cannot be extracted from the provided text.
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The document only says: "All tests were verified to meet the required acceptance criteria."
- Reported Device Performance: Not explicitly detailed. The document only states that the device is "substantially equivalent" to predicate devices and that "modifications have no impact on the safety and effectiveness of the device."
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: Not specified.
- Data Provenance: Not specified.
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)
- Not applicable. This device is a CPAP system, not an AI/imaging device requiring expert ground truth for a test set in the same way. The evaluation focuses on engineering and performance characteristics against predicate devices, not diagnostic accuracy based on expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and evaluation.
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, an MRMC study was not done, as this is a CPAP device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of AI-driven algorithm performance. However, "Design verification tests" imply standalone performance testing of the device's functions. The document just doesn't detail what exactly was tested or the results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would refer to its engineering specifications and predicate performance. The document states "Design verification tests were performed... as a result of the risk analysis and product requirements." This implies that the device's performance was compared against predetermined engineering and safety standards, rather than expert consensus on medical images or pathology reports.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 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).