(203 days)
The Pegasus™ Nasal CPAP System is intended for treatment of Adult Obstructive Sleep Apnea (OSA). The Pegasus™ Nasal CPAP System is intended only for spontaneously breathing patients.
The Pegasus™ Nasal CPAP System is intended to provide a requlated and continuous positive airway pressure for the treatment of adult individuals suffering from obstructive sleep apnea (OSA). The positive pressure is clinicianadiustable within the designed operating range, as is enabling of the bar graph pressure indicator mode. User controls are On/Off switch, selecting the physician-enabled bar graph, viewing the real-time clock and setting of the real-time clock. The Pegasus™ is designed to be used with a 22-millimeter, smooth-bore air delivery hose and user- or physician-selected nasal or face mask. The Pegasus™ consists of a plastic enclosure that surrounds a power supply, impeller and motor, microprocessor, motor controller, display and switch inputs.
Acceptance Criteria and Device Performance Study
The provided document describes the Pegasus™ Nasal CPAP System and its safety and effectiveness summary for 510(k) clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly defines acceptance based on compliance with device specifications and internationally accepted standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance to device specifications | "all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies." |
| Electrical safety standards compliance | "The Pegasus complied with the requirements of these standards." (Internationally accepted standards for electrical safety) |
| Electro-magnetic compatibility (EMC) standards compliance | "The Pegasus complied with the requirements of these standards." (Internationally accepted standards for electro-magnetic compatibility) |
2. Sample Size and Data Provenance
The document states "Performance testing was conducted in the laboratory." It does not specify a distinct "test set" in terms of subject or patient data. The testing appears to be based on evaluating the device's functional performance against its specifications and relevant standards.
- Sample Size for Test Set: Not applicable as the testing described is functional and compliance-based, not involving a patient test set.
- Data Provenance: Not applicable. The testing was laboratory-based.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not applicable. The ground truth for this type of device (functional performance, electrical safety, EMC) is established through engineering and regulatory standards, not expert clinical consensus on patient data.
- Qualifications of Experts: The testing was performed by a "Nationally Recognized Testing Laboratory (NRTL)," implying qualified engineers and technicians experienced in electrical safety and EMC testing conducted the evaluation.
4. Adjudication Method
- Adjudication Method: Not applicable. The nature of the performance testing (functional compliance, electrical/EMC standards) does not involve adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is a therapeutic device (CPAP system), not an diagnostic imaging or AI-driven interpretive system that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Not applicable. The Pegasus™ Nasal CPAP System is a hardware device with embedded software for control, not a standalone algorithm/AI system in the sense of predictive or interpretive software. Its "performance" refers to its physical functioning and adherence to engineering specifications.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was based on device specifications and internationally accepted standards for electrical safety and electro-magnetic compatibility.
8. Sample Size for Training Set
The document does not mention a "training set" as it is typically understood in the context of machine learning or AI models. This device is a hardware-based medical device.
- Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
§ 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).