(77 days)
The Orion Nasal CPAP System is intended for treatment of Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is defined as the absence of air movement in ten seconds during sleep. Obstructive Sleep Apnea is usually diagnosed through a sleep study. The study obtains the optimum level of pressure required to maintain airway pressure to the obstructed airway. The positive pressure allows the airway to stay open. The Orion Nasal CPAP System is intended only for spontaneously breathing patients.
The Orion Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician-adjustable within the designed operating range, and a clinicianadjustable time allows at timed rise to the set pressure. The user controls are limited to an On/Off switch and the optional pre-set time rise to the set pressure. This device is designed to be used with a 22-millimeter, smooth-bore air delivery hose and user-selected nasal or face mask. The Orion consists of a plastic enclosure that surrounds a power supply, impeller and motor, microprocessor, motor controller, display and switch inputs.
Here's an analysis of the provided text regarding the Orion Nasal CPAP System's acceptance criteria and studies, organized according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | All functions operate as designed and intended. | Verified; all functions operated as designed and intended. |
| Measured parameters meet required ranges and accuracies. | Verified; measured parameters met required ranges and accuracies. | |
| Electrical Safety | Compliance with internationally accepted standards. | Complied with the requirements of internationally accepted standards for electrical safety (tested by NRTL). |
| Electro-Magnetic Compatibility (EMC) | Compliance with internationally accepted standards. | Complied with the requirements of internationally accepted standards for electro-magnetic compatibility (tested by NRTL). |
| Substantial Equivalence (General) | Not significantly different from a predicate device. | Determined to be substantially equivalent to the Bird Products Corporation Softaire/Alura Nasal CPAP System (K990856). |
| Intended Use | For treatment of Obstructive Sleep Apnea (OSA) in adults. | System is intended for this use. |
| Applies to spontaneously breathing patients. | System is intended for this type of patient. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set involving patients or clinical data. The performance testing described is limited to laboratory verification of device functions and compliance with engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the performance testing was laboratory-based and focused on engineering specifications and safety standards, there is no mention of experts establishing a "ground truth" in a clinical sense for a test set. The "ground truth" here would be the engineering specifications and international standards, which are evaluated through direct measurement and compliance testing.
4. Adjudication Method for the Test Set
As the testing was primarily laboratory-based and focused on objective measurements against engineering specifications and international standards, an adjudication method is not applicable in the context of clinical evaluation or expert consensus. Compliance was determined by direct measurement and verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The provided information solely pertains to the device's functional performance, electrical safety, and EMC in a laboratory setting, and its substantial equivalence to a predicate device. There is no mention of human readers or AI assistance in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study describing the performance of an algorithm without human-in-the-loop interaction was not done or reported. The Orion Nasal CPAP System is a hardware device, not an AI or algorithmic diagnostic tool.
7. The Type of Ground Truth Used
The "ground truth" used for the reported performance testing was primarily engineering specifications and internationally accepted standards for electrical safety and electromagnetic compatibility. This is demonstrated by statements like "all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies" and "the Orion complied with the requirements of these standards."
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. This is because the device described is a physical medical device (CPAP machine) and not an AI or machine learning model that would require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the question of how its ground truth was established is not applicable to this device submission.
§ 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).