(161 days)
The BiPAP Harmony S/T is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.
The BiPAP Harmony S/T is a noninvasive pressure support ventilator and is classified under product code MNS (ventilator, continuous, non-life supporting). It is an electromechanical device and contains no software. The BiPAP Harmony S/T ventilator provides therapy in a Spontaneous/Timed (S/T) mode. A clinician sets IPAP/EPAP, Rate and Inspiratory Time. The device delivers patient triggered, pressure limited, patient cycled breaths if the patient's breathing rate is above the rate setting. The device delivers machine triggered, pressure limited, time cycled breaths if the patient's breathing rate falls below the rate setting. The inspiratory time setting controls the duration of the inspiratory phase. The inspiratory time setting does not affect the cycling of a spontaneous breath.
This document describes the BiPAP Harmony S/T, a non-invasive pressure support ventilator. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing and compliance with relevant standards, rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way a diagnostic AI device submission might.
Therefore, many of the requested categories for AI device evaluation are not applicable or cannot be extracted directly from this document.
Here's the information that can be extracted or derived:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria. Instead, it states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Safety & Effectiveness | "Testing was performed to demonstrate that the performance of the BiPAP Harmony S/T in its intended environment is as safe and effective as that of the legally marketed predicate device." |
| Compliance with Standards | "The BiPAP Harmony S/T was tested and found compliant (as applicable for Code MNS) with the standards referenced in the 'Draft FDA Reviewer Guidance for Ventilators,' July 1995 as well as with the 'Draft Reviewer Guidance for Premarket Notifications,' November 1993." |
| Performance Features | The device "Provides non-invasive application of bi-level and continuous positive airway pressure I support ventilation." |
| "Provides spontaneous triggering based on the Respironics Auto-Trak™ Sensitivity system." | |
| "Compensates for most leaks in the patient circuit and patient interface." | |
| "Compensates the unit outlet pressure for flow based pressure drops in the patient circuit." | |
| Safety Features | "Provides built-in alarms for high pressure, low pressure, and pressure regulation." |
| "Provides internal circuit monitoring for safety." | |
| "Provides an optional oxygen valve that closes, preventing oxygen flow, when the unit is turned off or power fails." | |
| "Provides a patient disconnect alarm with a time delay that is set by trained personnel." |
2. Sample size used for the test set and the data provenance
This information is not provided. The document refers to "performance-related testing" and "electrical safety, electromagnetic compatibility, mechanical and environmental testing" but does not detail the nature or sample size of these tests in relation to a "test set" of patient data. Given this is a hardware ventilator, "data provenance" in the context of patient data for AI model validation is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a ventilator, not an AI diagnostic tool requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable for a hardware device described in this context.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
Not applicable. This is a hardware device, not an AI assistance system requiring a human-in-the-loop study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is described as an electromechanical device containing no software.
7. The type of ground truth used
Not applicable in the context of clinical "ground truth" for diagnostic or AI performance. The "truth" for this device relates to engineering specifications, physical performance (e.g., pressure delivery, leak compensation), and safety feature functionality, which would be verified through specific engineering and bench testing rather than patient outcome or expert consensus data in the traditional sense of "ground truth" for AI.
8. The sample size for the training set
Not applicable. This device is an electromechanical ventilator with no software; therefore, there is no "training set" in the context of AI or machine learning.
9. How the ground truth for the training set was established
Not applicable for the same reasons as above.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).