(254 days)
The Morphee Plus Alpha is intended to manage obstructive sleep apnea by delivering air pressure through a tube and mask. It is intended for use in either the hospital or home environment.
The Morphee Plus Alpha System consists of a line powered control unit, an air tube and a patient mask. The mask is attached to the patient covering the nose and secured with straps. The air tube attaches to the mask and the control unit allowing airflow from the control unit to the mask as well as respitory sensing by the control unit. The control unit offers both continous (CPAP) and automatice modes. In the continuous mode, the unit functions as a standard CPAP product. The auto mode allows the control unit to adjust the airway pressure based on the patient's respiration.
This describes the acceptance criteria and the study that proves the Morphee Plus Alpha Obstructive Sleep Apnea Management System meets those criteria, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety Standards | National electrical safety standards | Met all requirements |
| International electrical safety standards | Met all requirements | |
| Electromagnetic compatibility standards | Met all requirements | |
| Mechanical Performance | Mechanical performance requirements | Met all requirements |
| Environmental Performance | Environmental performance requirements | Met all requirements |
| Biocompatibility | Biocompatibility requirements | Met all requirements |
| Intended Use | Suitable for managing obstructive sleep apnea via predetermined positive air pressure | Suitable for the intended use |
| Equivalence | Substantially equivalent clinical indications, theory of operation, and basic product design to predicate devices | Substantially equivalent to predicate devices (Companion 31g Nasal CPAP System, DPAP Interactive Airway Management System) |
2. Sample Size and Data Provenance for the Test Set
The provided document does not specify a sample size for a test set related to clinical performance or patient data. The performance testing described focuses on safety and engineering standards.
3. Number of Experts and Qualifications for Ground Truth
The provided document does not mention using experts to establish ground truth in the context of clinical performance data. The testing described appears to be engineering and safety-focused.
4. Adjudication Method for the Test Set
The provided document does not mention any adjudication method, as no clinical test set requiring such a method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. The submission focuses on device safety and substantial equivalence to existing predicate devices, not on improving human reader performance with AI.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study focused on an algorithm's performance in a clinical context was not done or at least not described in this document. The device, Morphee Plus Alpha, is an Obstructive Sleep Apnea Management System, implying a physical device for delivering CPAP, not an AI or algorithm-only diagnostic tool. The "auto mode" mentioned indicates an automated function of the device, but its performance is not detailed in the context of a standalone study.
7. Type of Ground Truth Used
The "ground truth" for the performance testing cited in this document was based on:
- Compliance with national and international product safety standards (electrical, electromagnetic compatibility).
- Meeting mechanical, environmental, and biocompatibility requirements.
- The device's ability to perform its intended function (manage obstructive sleep apnea by delivering positive air pressure).
8. Sample Size for the Training Set
The provided document does not mention a training set size. This type of submission (510(k) for a physical medical device like a CPAP machine) typically does not involve machine learning algorithms that require large training datasets in the way an AI diagnostic tool would.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned for a machine learning context, the establishment of ground truth for a training set is not applicable as per this document. The "ground truth" for the device's design and functionality would be based on engineering specifications, regulatory guidelines, and clinical understanding of obstructive sleep apnea treatment.
§ 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).