(52 days)
The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP). The S8 Pioneer system is intended for home and hospital use.
The S8 Pioneer CPAP System is similar to the predicate devices, (AutoSet Spirit, S8 Prime and VPAP III) it is smaller, with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of OSA. Treatment modes are self-adjusting, CPAP and CPAP with Expiratory Pressure Relief (EPR). CPAP with EPR provides a comfort to patients who experience difficulty in breathing out aqainst CPAP during the expiratory phase. The system comprises the Flow Generator, patient tubing, mask (patient interface) and Smart Card (SC) Module or DB9 Adapter for receiving and sending data. The performance and functional characteristics of the S8 Pioneer CPAP system includes all the clinician and user friendly features of the predicate devices, Autoset Spirit, S8 Prime and VPAP III.
The provided text is a 510(k) summary for the ResMed S8 Pioneer CPAP System. It discusses the device's substantial equivalence to predicate devices and its intended use. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, especially in the context of performance metrics like sensitivity, specificity, or reader aid improvement in a comparative effectiveness study.
The document states that "Design and Verification activities were performed on the S8 Pioneer CPAP System as a result of the risk analysis and product requirements. All tests confirmed the product met the acceptance criteria." However, it does not elaborate on what those acceptance criteria were or provide the results of those tests.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies as the information is not present in the provided text.
Based on the provided information, I can only state that:
- Acceptance Criteria and Reported Device Performance: The document generally states that "All tests confirmed the product met the acceptance criteria" without detailing the specific criteria or performance metrics.
- Study Information (Sample sizes, ground truth, experts, adjudication, MRMC, standalone): This information is not present in the provided 510(k) summary. The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than a clinical performance study with detailed metrics.
- Training Set Information: This information is not present in the provided 510(k) summary.
§ 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).