Search Results

The Alice PDx is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.

The Alice PDx is a wearable data recorder that collects and stores physiological signals. The role of the Alice PDx is only to record the data. The following physiological signals may be collected and stored by the Alice PDx device:

• EEG, EOG, EMG, ECG
• Nasal/oral Airflow
• Snore
• Thoracic and Abdominal Effort
• Body Position
• Pulse Oximetry, including:
  • Oxygen Saturation (SpO2)
  • Pulse Rate
  • Plethysmograph

The recorded data is stored on a secure digital (SD) card and may be passed on to a PC for analysis and reporting of the data by the Respironics Sleepware Software application. The Alice PDx data recorder is not in any way involved in the data management performed by the host.

The provided document, a 510(k) Premarket Notification for the Respironics Alice PDx, states that "Design verification tests were performed on the Alice PDx as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, it does not provide details about specific acceptance criteria or the results of these tests.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from the provided text.

Additionally, the document does not contain information regarding:

• Sample size used for the test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human readers with/without AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., expert consensus, pathology, outcome data).
• The sample size for the training set.
• How ground truth for the training set was established.

The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Respironics Galaxy K083874) based on shared intended use, operating principle, technology, and manufacturing process. It confirms that the device records data for various physiological signals and is intended for use with clinical software for polysomnography and sleep disorder studies.

Ask a specific question about this device