Search Results

The BiPAP Duet System delivers CPAP and bi-level positive airway pressure therapies for the treatment of adult OSA. The BiPAP Duet System is intended for use in the home and by a qualified clinician (any individual trained to perform sleep study diagnoses) in clinical (hospital or sleep laboratory) settings where adult patients suffering from OSA are diagnosed and treated. When used in clinical settings, the BiPAP Duet System can be used with or without the Respironics Maestro Clinical Remote Control. The BiPAP Duet System is used in conjunction with masks, headgear, and various combinations of patient circuit accessories.

The BiPAP Duet System is intended to apply CPAP and bi-level positive airway pressure therapies to adult patients who suffer from OSA. The device can operate on either 115 - 120 Volts AC or 230 - 240 Volts AC. The System consists of the BiPAP Duet device and the recommended patient circuit that is used to direct the air to the patient. The tubing, exhalation port, humidifier (if needed), and mask are referred to as the patient circuit. Also, the Maestro CRC can be used in clinical settings to provide control from a remote location. The Maestro CRC also provides data monitoring capabilities, alphanumeric and graphical representations of patient data, and recording capabilities via DC outputs that optionally connect to a polysomnograph for data recording.

The primary components of the BiPAP Duet device are a blower motor assembly and a microprocessor control system. The blower motor is capable of generating positive airway pressures from 4 to 20 cm H2O. The level of pressure is dependent on motor speed and a pressure control valve, which are controlled by a microprocessor-controlled feedback system.

The provided text describes a medical device, the BiPAP Duet System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of a typical performance study with a test set, ground truth, or expert review.

Instead, the document focuses on demonstrating substantial equivalence through a comparison with an existing, legally marketed device (Respironics BiPAP S-D System) and performance testing related to safety and effectiveness.

Here's an analysis based on the information provided, highlighting what's present and what's missing:

Missing Information: The document is primarily a premarket notification summary (510(k)) and focuses on substantial equivalence rather than a clinical trial or performance study against specific acceptance criteria for diagnostic accuracy or similar metrics. Therefore, many of the requested elements for a typical performance study (like test set size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, training set details) are not explicitly detailed.

What is Available in the Document:

1. Acceptance Criteria and Reported Device Performance (Implicit):
   The "acceptance criteria" here are implied to be the safety and effectiveness standards met by the predicate device, and compliance with general medical device standards. The "reported device performance" is a statement of compliance.

   Acceptance Criteria (Implicit)	Reported Device Performance
   As safe and effective as the legally marketed predicate device (BiPAP S-D System).	"The BiPAP Duet System is substantially equivalent to the Respironics BiPAP S-D System..." and "Testing was performed to demonstrate that the performance of the BiPAP Duet System in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of the BiPAP Duet System was verified through performance related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical, and Environmental Testing. The BiPAP Duet System was found compliant and has been certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications.'"
   Accuracy for Estimated Patient Flow	-120 to 120 L/min with an accuracy of ± 10% at standard temperature and pressure.
   Accuracy for Leak	0 to 120 L/min with an accuracy of ± 10% or ± 10 L/min (whichever is greater) at standard temperature and pressure.
   Pressure Range (IPAP/EPAP)	4.0 to 20.0 cm H2O (Bi-level mode), with a note about 3.0 cm setting.

2. Sample Size used for the test set and the data provenance:

   • Not explicitly stated in terms of patient data or clinical images. The "testing" mentioned refers to Electrical Safety, Electromagnetic Compatibility, Mechanical, and Environmental Testing, which would likely involve device units themselves rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable based on the type of testing described. This document is not detailing a study where expert review established ground truth for diagnostic decisions.

4. Adjudication method for the test set:

   • Not applicable. See point 3.

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:

   • Not applicable. This device is a ventilatory support system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The context of "standalone" here would refer to the device's functional performance. The document states: "Testing was performed to demonstrate that the performance of the BiPAP Duet System in its intended environment is as safe and effective as that of the legally marketed predicate device." This "performance testing" represents the device's standalone operation meeting regulatory standards.

7. The type of ground truth used:

   • For the functional aspects (e.g., pressure delivery, flow/leak measurement), the ground truth would be engineering specifications, calibrated measurement equipment, and compliance with recognized standards. It is not an expert consensus or pathology diagnosis in the typical clinical study sense.

8. The sample size for the training set:

   • Not applicable. This document describes a medical device, 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. See point 8.

Ask a specific question about this device