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The BiPAP S/T-D System is intended for hospital or institutional use for treatment of obstructive sleep apnea, respiratory failure, or respiratory insufficiency.

The BiPAP S/T-D System is a ventilation support system designed to augment a patient's ability to breathe on a spontaneous basis. It is not intended for life support situations. The BiPAP S/T-D System is intended for hospital or institutional use for treatment of obstructive sleep apnea, respiratory failure, or respiratory insufficiency. The BiPAP S/T- D offers four modes of operation: Continuous Positive Airway Pressure (CPAP), Spontaneous (S) mode, Spontaneous/Timed (S/T) mode, and Timed (T) mode. The BiPAP S/T-D System provides ventilation support by applying a positive pressure (IPAP) during the inspiratory seqment of a breathing cycle, and subsequently cycling to a lower pressure level (EPAP) during the expiratory seqment of the cycle for spontaneous breaths. The transition point between inspiration and expiration is sensed by the BiPAP S/T-D System as a function of a decrease in patient flow demand. The BiPAP S/T-D System also senses the transition point between expiration and inspiration. As the patient begins to inhale, the BiPAP S/T-D System senses the increase and transitions from EPAP to IPAP. These points are called the trigger thresholds. The BiPAP S/T-D System has the capability of monitoring delivered pressure and adjusting flow as applied to the patient circuit to maintain set IPAP and EPAP pressures. The System is also capable of compensating for air leakage around the patient interface.

The provided text describes the BiPAP S/T-D System, a ventilation support system. Here's a breakdown of the acceptance criteria and the studies conducted to demonstrate its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Additional Safety and Environmental Criteria:

The device also met various national and international standards for electrical safety, electromagnetic compatibility, shock, and vibration:

• Canadian Standards Association (CSA) C22.2 125
• UL544 Medical and Dental Equipment Standards
• German Postal Law Requirements for Conducted and Radiated Emissions per VFG 234/1991
• IEC 68-2-6 (sinusoidal vibration), IEC 68-2-27 Shock, and IEC 68-34 Random Wide Band Vibration
• Shock and vibration for the final packaged configuration per National Safe Transit Association Test Labs
• Electromagnetic compatibility testing to IEC 601-1-2 (including IEC 801-1, -2, -3 and CISPIR 14)
• MIL-STD-461D and MIL-STD-462D for magnetic field susceptibility
• FCC Class B, Part 15.J Emissions

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (Clinical Data):
  • Prospective, Randomized, Controlled Clinical Studies: 31 adult patients with acute respiratory failure.
  • Prospective, Non-Randomized Studies: 81 patients.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It describes them as "clinical studies" without further geographical details. The studies were prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• This information is not provided in the document. The text refers to "clinical data" and "statistical basis" but does not detail how the outcome measures (e.g., intubation avoidance) were assessed or validated by specific medical experts for the studies.

4. Adjudication Method for the Test Set:

• This information is not provided in the document.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The BiPAP S/T-D System is described as a medical device for ventilation support, not an AI-powered diagnostic or assistive tool that would involve human "readers" interpreting output.

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

• Yes, a form of standalone performance assessment was done. The "technical data presented" and "functional testing" against published specifications (pressure regulation, control accuracy, etc.) represent the device's standalone performance. The device's ability to maintain set pressures and respond to patient flow patterns is a function of its internal design and algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the technical specifications (pressure, flow, accuracy), the "ground truth" would be established by precise measurement instruments and calibrated standards.
• For the clinical studies, the primary outcome measure was whether the BiPAP System could "successfully avoid the need for intubation." This would fall under outcomes data.

8. The sample size for the training set:

• The document describes a medical device, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this submission. The device's operational parameters and algorithms are based on engineering design and physiological principles, not on data training in the AI sense.

9. How the ground truth for the training set was established:

• As there is no "training set" for an AI model in this context, this question is not applicable. The device's design and functionality are based on established engineering and medical principles for ventilator operation.

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