(85 days)
The Stardust II is a multi-function recording device intended to be used to collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders. The Stardust II is only to be used under the direction and supervision of a physician, technologist or clinician.
The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events:
- Airflow (acquired with a pressure cannula or thermistor sensor) .
- Effort .
- SpO2 .
- . Pulse rate
- Apnea ●
- Hypopnea ♥
- Desaturation .
- Snore .
The Stardust II can also interface with various Respironics pressure therapy devices to report available device/patient information (i.e., event flags and real time streamed data). When used with these devices, the Stardust II is not intended to be a diagnostic application, but rather a portable recorder to assess the quality of the at home titration of an auto-titrating device and determine if there are still events occurring and to assess the therapeutic benefit of the already diagnosed OSA patient.
This looks like a medical device submission, specifically a 510(k) summary for the Stardust II device. The provided text does not contain specific acceptance criteria or the details of a study demonstrating the device meets those criteria, nor does it provide performance data, sample sizes, ground truth establishment, or information on reader studies.
The submission focuses on establishing substantial equivalence to a predicate device and describing the intended use and device functionality. It states that "Design verification tests were performed on the Respironics Stardust II as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, it does not elaborate on what those criteria were, what the "reported device performance" was, or the details of the study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for test sets.
- Information on MRMC comparative effectiveness studies or standalone studies.
- Details on the type of ground truth used or how it was established for training and test sets.
The provided text only contains the following relevant information regarding your request:
- Device Name: Stardust II Ventilatory Effort Recorder
- Intended Use: To collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders.
- Key Functionality: Records physiological signals and uses proprietary algorithms to determine and report respiratory waveforms and events (Airflow, Effort, SpO2, Pulse rate, Apnea, Hypopnea, Desaturation, Snore).
- Statement on Testing: "Design verification tests were performed on the Respironics Stardust II... All tests were verified to meet the required acceptance criteria."
Without additional documentation (e.g., from an appendix or supporting study report that would typically be part of a full 510(k) submission but are not included in this summary), I cannot provide the specific details you've requested.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).