(91 days)
The S8 Prime CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Prime CPAP System is intended for home and hospital use.
The S8 Prime CPAP System is similar to the predicate devices, (Sullivan III and S7 Elite CPAP System) it is smaller and lighter, with a new and improved micro-processor controlled blower system that it is smaller and lighter, with a new and improved micro prom 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the Flow Generator, patient tubing, ail spline for enodires trouth Smart Card (SC) Module or DB9 Adapter for receiving and sending data.
The performance and functional characteristics of the S8 PRIME CPAP system includes all the clinician and user friendly features of the predicate devices, Sullivan III and S7 Elite CPAP System.
The provided text does not contain detailed acceptance criteria for specific performance metrics of the S8 Prime CPAP system, nor does it include a study that quantitatively proves the device meets such criteria with numerical results or statistical analysis.
However, based on the information provided, we can infer the general acceptance criteria and the nature of the "study" (design and verification activities) conducted.
Here's a breakdown based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients for home and hospital use. | The S8 Prime CPAP System meets this. |
| Operating Principle | Similar operating principle to predicate devices. | The S8 Prime CPAP System uses a micro-processor controlled blower system to maintain an "air splint" for OSA, similar to predicates. |
| Technology | Similar technologies to predicate devices. | The S8 Prime CPAP System incorporates a new and improved micro-processor controlled blower system. |
| Manufacturing Process | Same manufacturing process as predicate devices. | The S8 Prime CPAP System uses the same manufacturing process as predicate devices. |
| Risk Analysis / Safety | Meet safety and effectiveness requirements based on risk analysis. | "Design and Verification activities... resulted in the product met the acceptance criteria." "ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment." |
| Performance Range | Deliver therapeutic pressure range (e.g., 4-20 cmH2O). | The S8 Prime CPAP System delivers a pressure range from 4-20 cmH2O. |
| Functional Equivalence | Possess similar clinician and user-friendly features as predicate devices. | The S8 Prime CPAP system includes all the clinician and user friendly features of the predicate devices. |
| Regulatory Compliance | Complies with relevant FDA guidance documents and regulations. | Design and Verification performed with reference to FDA guidance documents (e.g., FDA Reviewer Guidance for Premarket Notifications, FDA Draft Reviewer Guidance for Ventilators, Guidance for software in medical devices). |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify a numerical sample size for a "test set" in the context of clinical performance. The "Design and Verification activities" mentioned likely refer to engineering and functional testing rather than a clinical trial with a statistically defined patient sample.
- Data Provenance: Not applicable in the context of a clinical test set. The activities were performed by ResMed, presumably at their facilities.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- This information is not provided. The phrase "ground truth" typically refers to an authoritative diagnostic determination in clinical studies. Given the nature of the submission (510(k) for substantial equivalence based on engineering and functional testing), a formal "ground truth" established by experts in a clinical setting for a test set is not discussed.
4. Adjudication Method for Test Set
- Not applicable/Not mentioned. There is no indication of a clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical and functional similarity to predicate devices, not on a clinical comparison of human reader performance with or without AI assistance.
6. Standalone Algorithm Performance
- Not applicable. This device is a hardware CPAP system, not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this specific product.
7. Type of Ground Truth Used
- For the "Design and Verification activities," the "ground truth" would be engineering specifications, performance standards, and the functional characteristics of the predicate devices. There is no indication of a clinical "ground truth" derived from pathology or patient outcomes data in this submission.
8. Sample Size for the Training Set
- Not applicable. This document describes a physical medical device (CPAP machine), not a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for a machine learning algorithm.
§ 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).