(90 days)
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 Aspen self-adjusting system is intended for home and hospital use.
The S8 Aspen System (S8 Aspen with HumidAire 4i Plus) is similar to the predicate device(s), with a new and improved power supply and heater controller for the HumidAire 4i Plus. The S8 Aspen contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHz as required for the treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
This 510(k) summary (K691947) describes the S8 Aspen, a non-continuous ventilator (IPPB) intended for the treatment of obstructive sleep apnea (OSA).
1. Table of Acceptance Criteria and Reported Device Performance & Study Details
Unfortunately, the provided 510(k) summary does not contain a specific table of acceptance criteria or reported device performance metrics in the format requested. It states that "Design and Verification activities were performed on the S8 Aspen System as a result of the risk and vis and Design and VChildullion activities were performed the predetermined acceptance critieria. Resided has design requirements." This implies that internal design requirements and acceptance criteria were established and met, but these specific criteria and their corresponding results are not detailed in this public summary.
The summary focuses on demonstrating substantial equivalence to predicate devices (VPAP ST (K080131) and VPAP Auto (K082605)) rather than providing a detailed performance study with quantifiable acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. The statement "Design and Verification activities were performed on the S8 Aspen System" suggests internal testing was conducted, but details regarding the nature of this testing (e.g., clinical trials, bench testing, specific datasets) are not provided. Therefore, data provenance (country of origin, retrospective/prospective) is also not available from this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this 510(k) summary primarily focuses on substantial equivalence based on design and verification activities, and does not describe a clinical study with a "test set" in the context of expert-adjudicated ground truth (e.g., for image analysis or diagnostic accuracy), this information is not applicable and not provided.
4. Adjudication Method for the Test Set
As no specific clinical test set requiring expert adjudication for ground truth is described, this information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The submission aims for substantial equivalence based on device design and functional characteristics, not comparative clinical outcomes with human readers. Therefore, an effect size of AI assistance for human readers is not discussed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a "self-adjusting system" for treating OSA, implying an inherent automated function. However, the summary does not explicitly detail a standalone algorithm performance study without human interaction in the context of a diagnostic or assistive AI system. The focus is on the device's overall functionality and safety, not on the isolated performance of an "algorithm" in the way it might be for a purely diagnostic AI tool.
7. The Type of Ground Truth Used
As no specific clinical test set requiring expert ground truth or diagnostic evaluation is detailed, the document does not specify the type of ground truth used. The "Design and Verification activities" would likely involve engineering specifications, functional testing against expected outputs, and potentially limited human factor evaluations, but not a "ground truth" for a diagnostic accuracy claim.
8. The Sample Size for the Training Set
The provided summary does not mention a training set sample size. This type of information is typically relevant for machine learning-based devices or algorithms that are "trained" on data. While the device is "self-adjusting," the description does not indicate a machine learning component that would require a distinct training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described in the summary, this information is not applicable and not provided.
§ 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).