(111 days)
The Respironics BiPAP Vision® Ventilatory Support System is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non-invasive applications.
The BiPAP Vision is intended for use in a hospital environment (including sleep labs, respiratory care units) or alternate care site (e.g., transitional care centers, skilled nursing homes, ambulatory care centers) by respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician.
The BiPAP Vision is used with various combinations of Respironics-approved patient circuit accessories, such as patient interface devices (masks and tracheal tube adapter), humidifiers, and circuit tubing.
The BiPAP Vision can provide therapy in the modes of continuous positive airway pressure (CPAP), and pressure support ventilation, with preset, machine assisted breaths available as a backup to the patient's respiratory spontaneity, i.e., the Spontaneous/Timed (S/T) mode. Both modes of operation of the BiPAP Vision provide accurate and reliable delivery of pressurized air, at flows sufficient to accommodate the needs of adult patients (≥ 30 kg). The BiPAP Vision is a microcontroller-based, pressure assist, critical care, continuous ventilator that has been provided with digital and analog process control and variable monitoring capabilities, and a comprehensive array of alarms, engineered safety features and self diagnostic functions. The BiPAP Vision architecture, and the electrical, mechanical and material specifications of all system components were selected to optimize performance and reliability. The BiPAP Vision also incorporates a number of safety features and self-diagnostic testing capabilities.
A Liquid Crystal Display (LCD) video screen mounted on the front of the unit, together with an array of keys and a rotary adjustment knob, provide the primary user interface with the BiPAP Vision. The display includes waveform or bargraph representation of the process variables, and a digital display of the control settings and any alarm conditions. User interaction with the device is accomplished by keystrokes and rotation of the adjustment knob while observing the results of this manipulation on the display. The information provided on the display varies depending on the operating mode and/or the operations being performed.
This document describes the BiPAP Vision Ventilatory Support System, identified by K982454, a device intended to augment patient breathing. The information provided focuses on demonstrating its substantial equivalence to predicate devices and its safety and effectiveness through various testing and compliance with standards.
Here's an analysis of the provided text, broken down by your requested criteria:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or detailed device performance metrics in a tabular format. Instead, it states that the device was found to be "compliant and has been certified to the applicable sections of the following standards." The acceptance criterion effectively is compliance with relevant safety and performance standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards: | Compliant and certified to: |
| IEC 601-1: General Requirements for Safety of Medical Electrical Equipment | Yes |
| IEC 801-1: Electromagnetic Compatibility for Industrial Process and Measurement and Control Equipment, Part 1 | Yes |
| IEC 801-2: Electrostatic Discharge Requirements | Yes |
| IEC 801-3: Radiated Electromagnetic Field Requirements | Yes |
| IEC 801-4: Electrical Fast Transients/Burst Requirements | Yes |
| CISPR 11: Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific, and Medical Equipment | Yes |
| IEC 68-2-6: Basic Environment Test Procedures, Part 2: Tests. Test Fc and Guidance: Vibration (Sinusoidal) | Yes |
| IEC 68-2-27: Basic Environment Test Procedures, Part 2: Tests. Test Ea and Guidance: Shock | Yes |
| IEC 68-2-34: Basic Environment Test Procedures, Part 2: Tests. Test Fdc: Random Vibration Wide Band - Reproducibility Low | Yes |
| MIL-STD-461D: Requirements for Control of Electromagnetic Interference Emissions and Susceptibility | Yes |
| MIL-STD-462D: Measurements of Electromagnetic Interference Characteristics | Yes |
| MIL-STD-810E: Environmental Test Methods | Yes |
| Performance Standards: | Compliant with: |
| ASTM F 1100-90 | Yes |
| "Draft FDA Reviewer Guidance for Premarket Notifications, November 1993" | Yes |
| "Draft Reviewers Guidance For Ventilators", July 1995 | Yes |
| Functional testing against product specifications | Yes (stated "functional testing of the device against product specifications") |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size or data provenance for any clinical or performance test set. The testing described appears to be primarily laboratory-based engineering and compliance testing of the device itself, rather than human subject testing with a defined sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not mention the involvement of experts to establish a "ground truth" for a test set. The ground truth for the testing described is the adherence to established engineering standards and functional specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method as it relates to expert review or consensus for a test set. The validation relies on compliance with objective engineering and performance standards.
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 MRMC comparative effectiveness study was mentioned or performed. This device is a ventilatory support system, not an AI-assisted diagnostic tool for human readers. Therefore, there's no mention of human readers, AI assistance, or effect sizes related to image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the performance of the BiPAP Vision Ventilatory Support System as a standalone device (algorithm only, in the sense of the device's internal control logic) through its compliance with various engineering, safety, and performance standards. The "testing was performed to demonstrate that the performance of the BiPAP Vision in its intended environment is as safe and effective as that of each of the legally marketed predicate devices." This implies testing the device's inherent functional capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests described is the defined requirements and specifications of the referenced industry and regulatory standards (e.g., IEC, ASTM, MIL-STD, FDA Draft Guidances) and the device's own product specifications. The device’s performance was measured against these established benchmarks.
8. The sample size for the training set
The document does not refer to a "training set" as this typically applies to machine learning or AI models. This submission is for a medical device (ventilator), not an AI algorithm.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of AI/machine learning, this question is not applicable to the information provided.
§ 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).