(88 days)
The S8 EscAPE II CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 ESCAPE II is intended for hospital and home use.
The S8 EscAPE II CPAP System is similar to the predicate devices, (S8 Prime, S8 Pioneer and S7 Elite CPAP System with H2i) with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The performance and functional characteristics of the S8 EscAPE II CPAP system includes all the clinician and user friendly features of the predicate devices.
The provided text is a 510(k) summary for the ResMed S8 Escape II CPAP System. It states that "Design and Verification activities were performed on the S8 EscAPE II 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 explicitly detail the specific acceptance criteria or the study that proves the device meets those criteria.
The document focuses on demonstrating substantial equivalence to predicate devices (S8 Prime, S8 Pioneer, and S7 Elite) based on similarities in intended use, operating principles, technologies, and manufacturing processes. It confirms that the new device has not altered the safety and effectiveness of CPAP treatment.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's an analysis of what can be derived:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | All tests confirmed the product met the acceptance criteria (specific criteria and performance not detailed). The device generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "Design and Verification activities" and "All tests," but does not provide details of specific studies, test set sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For a device like a CPAP machine, "ground truth" during verification would likely refer to objective measurements against engineering specifications or established standards, rather than expert consensus on a test set in the way it applies to diagnostic algorithms. The document does not mention any expert involvement in establishing ground truth for testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies or studies where subjective assessments by multiple readers need to be reconciled. This document does not describe such a study for the device's verification.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-assisted diagnostic device, but a therapeutic device (CPAP system). Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical CPAP system, not an algorithm. Performance tests would relate to the physical function of the device, such as pressure delivery, flow rate, and safety features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified, but inferred to be engineering specifications and standards. For a CPAP device, "ground truth" for verification typically refers to established engineering specifications, performance standards (e.g., for pressure accuracy, flow stability, noise levels), and safety requirements. The document does not explicitly state the type of ground truth, but implies adherence to product requirements and applicable FDA guidance documents related to ventilators.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device (CPAP machine), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI/ML device requiring a training set.
In summary:
The 510(k) summary for the S8 Escape II CPAP System declares that "All tests confirmed the product met the acceptance criteria" as part of Design and Verification activities. However, it does not provide the specifics of those acceptance criteria, the methodology of the tests, sample sizes, or details typically found in a clinical study report. The document's primary purpose is to establish substantial equivalence to previously cleared predicate devices, thereby leveraging their established safety and effectiveness.
§ 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).