(96 days)
The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventifator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports.
VentNet's intended use is to supplement the operation of dispersed or remotely located mechanical ventilators. VentNet allows the remote monitoring of multiple ventilators from a central station. VentNet displays ventilator settings, ventilator alarm status and physiological patient information as communicated from the monitored mechanical ventilator. VentNet also includes an optional feature which causes automatic notification, via paging system to defined users of certain ventilator alarms. VentNet is not intended to replace on-hand competent medical staff in monitoring for, or responding to ventilator alarms but is intended to support that staff by notifying other respiratory care staff or ventilator specialists in the event of certain alarm conditions.
VentNet's secondary intended use is the automation of some of the record keeping and reporting functions performed during mechanical ventilation.
The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventifator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports.
The provided document is a 510(k) Premarket Notification summary for the VentNet Central Monitoring Station. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study is not available within this document. The document primarily describes the device's technical specifications and compares them to predicate devices to establish substantial equivalence based on non-clinical performance data.
Here's an analysis of the information that is available, based on the prompt's request:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way a clinical study would for an AI/medical device. Instead, it lists "Product and Technical Specifications" and "Device Claims" which implicitly serve as performance goals, and then leverages a comparison matrix to predicate devices to argue equivalence. No quantitative "reported device performance" against these specifications from a formal study is detailed.
However, we can infer some "acceptance criteria" from the "Device Claims" and "Product and Technical Specifications" sections. The "reported device performance" is then implicitly demonstrated by stating these specifications and implying they are met, as part of the overall argument for substantial equivalence via non-clinical testing.
| Acceptance Criteria (Inferred from Claims/Specifications) | Reported Device Performance (As stated in the document) |
|---|---|
| Monitoring Capacity (Wireless) | Up to 24 continuous mechanical ventilators |
| Monitoring Capacity (Hardwire) | Up to 16 continuous mechanical ventilators |
| Remote Monitoring Features | Displays ventilator settings, alarm status, and physiological patient information |
| User Interface | Uses graphical user interface conventions, compatible with mouse or touchscreen for ease of learning and operation |
| Ventilator Compatibility | Compatible with Nellcor Puritan-Bennett 7200 Series Ventilator (host port or DCI) and future compatible ventilators |
| Automatic Record Keeping | Automatically records ventilator settings and alarm events (up to 1000 records) with time and date stamps; records physiological patient information with alarm events. |
| Reporting Features | Predefined report formats; archiving data; exporting data to third-party information systems. |
| Alarm Status Display | Color-coded software buttons for each ventilator, with labels for patient ID and location; ability to investigate specific active alarm codes. |
| Paging System Integration | Optional configuration with paging systems for remote notification of certain alarm conditions; user-definable alarm message paths and notification conditions (primary/secondary message paths, individual ventilator/alarm conditions). |
| Security | Passcode protection to restrict access to functions that interrupt monitoring or cause data loss. |
| Central Station Electrical | 115 Vac, 60 Hz, 5 A (maximum) or 230 Vac, 50 Hz, 2.6 A (maximum) |
| Remote Radio Transceiver Defibrillation Protection | Not damaged by defibrillation, returns to normal operation within 15 seconds. |
| Computer Hardware | Pentium-100 MHz, 16 MB RAM, 1 GB Hard Drive, 3.5-inch Floppy Drive, Hercules Dynamite Video Board, Serial Mouse, 101-key Keyboard |
| Monitor Specifications | 15 inch or 17 inch diagonal screen, Touchscreen hardware installed, 800 x 600 pixel resolution, 256 colors |
| Operating Temperature | +10° C to +35° C (+50° F to +95° F) |
| Operating Relative Humidity | 30% RH to 80% RH (noncondensing) |
| Radio Transceiver Frequencies | Central Transceiver: 902-928 MHz; Remote Transceiver: 902-928 MHz |
| Radio Transceiver Output Power | Central Transceiver: +20 dBm (100 mW) minimum; Remote Transceiver: +15 dBm nominal, ±2.0 dB |
| Radio Transceiver FCC Compliance | Spectrum Usage: Spread spectrum (IAW FCC Par. 15.247) |
| Printer Compatibility | HPGL/2 and PCL5 compatible, minimum 2 MB printer memory. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document describes "non-clinical performance data review" based on testing for EMI, software verification/validation, environmental testing, and stress testing. This implies technical testing, not a study with a patient "test set."
- Data Provenance: Not applicable for a clinical test set. The data provenance mentioned is related to engineering and software testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with an associated ground truth established by experts. The device's function is data presentation and alarm relay, not diagnostic interpretation.
4. Adjudication method for the test set:
- Not applicable. No clinical test set.
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. This is not an AI diagnostic device. It's a central monitoring station for ventilators. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone system performance was evaluated through "software verification and validation of both the system software performance as well as the operating system software performance, environmental testing and stress testing both at the integration level and the system level." However, this refers to the system's technical functionality, not a standalone diagnostic algorithm's performance. The device is explicitly designed to support human staff, not replace them.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The performance data reviewed involved validation of technical specifications and software functionality, not clinical diagnostic accuracy against a ground truth.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning device that would require a "training set" for model development.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of device.
Study Proving Acceptance Criteria:
The document states: "The determination of substantial equivalence was based on an assessment of nonclinical performance data. The data includes testing for EMI compatibility and susceptability, software verification and validation of both the system software performance as well as the operating system software performance, environmental testing and stress testing both at the integration level and the system level. The conclusion drawn from a review of the data indicates that the VentNet is substantially equivalent to the predicate devices."
This statement indicates that the "study" proving the device meets its (implicitly stated) performance criteria and is "substantially equivalent" involved:
- EMI Compatibility and Susceptibility Testing: To ensure the device operates correctly in its intended electromagnetic environment without interference and is not unduly affected by external electromagnetic sources.
- Software Verification and Validation: To confirm that the software performs as designed and meets all specified technical and functional requirements. This would involve unit testing, integration testing, system testing, and potentially user acceptance testing.
- Environmental Testing: To ensure the device can withstand specified operating and storage conditions (temperature, humidity, etc.).
- Stress Testing: To evaluate the system's robustness and stability under extreme or heavy load conditions.
- Integration and System Level Testing: To confirm that all components work together correctly as a complete system.
This approach demonstrates meeting technical specifications and equivalency to predicate devices, rather than a clinical performance study with patient data and a diagnostic ground truth.
§ 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).