(98 days)
The SERVO-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.
The SERVO-i Ventilator with MR environment option is classified as MR Conditional for 1.T. 1.5T and 37 MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met.
The ventilator is a platform with several selectable ventilation modes, which monitor patients whom need respiratory assistance. The MR environment option makes it possible to qualify the Servo-i ventilator to be used in MR environment
The SERVO-i Ventilator System's acceptance criteria and testing are focused on its "MR environment option" which allows it to be used safely in conjunction with MRI scanners. The provided document is a 510(k) summary, which typically provides an overview of testing rather than a detailed study report.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for magnetic field strength, RF interference limits, or image artifacts) or precise, quantitative reported device performance values. Instead, it describes general claims of compatibility and safety.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| MR Compatibility Statement | The SERVO-i Ventilator with MR environment option is classified as MR Conditional for 1T, 1.5T, and 3T MR scanners. This implies that it is safe to use in the MR environment if specific conditions are met. |
| Ventilator Performance in MR Environment | The SERVO-i ventilator with MR option has been tested with 1.0, 1.5, and 3.0 Tesla (T) scanners without impairing its performance. |
| Impact on MR Image Quality | The SERVO-i ventilator with MR option has been tested with 1.0, 1.5, and 3.0 T scanners without impairing the image quality of the scanner. |
| Safety Margins | Vital parts of the ventilator have been tested for performance in excessive magnetic fields to evaluate the safety margins. (No specific margin values reported) |
| Electromagnetic Emission Reduction | The emission from the SERVO-i has been further decreased with the MR option to reduce the probability for artifacts on the scanner images. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the devices tested. It refers to "the SERVO-i ventilator with MR option" in general terms.
- Data Provenance: The document implies the testing was conducted by Maquet Critical Care AB, which is a Swedish company. The nature of the testing (e.g., lab testing, in-house verification) suggests it's prospective data generated specifically for this submission. There is no indication of patient data or retrospective studies for this specific MR compatibility claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" in the typical sense for clinical performance. The testing described appears to be engineering and compatibility testing to ensure the device functions correctly in an MR environment and does not interfere with the MRI scanner. Therefore, no information on the number or qualifications of clinical experts for ground truth is provided.
4. Adjudication Method for the Test Set
Not applicable. The testing described is technical verification and validation of MR compatibility, not clinical performance requiring adjudication of patient cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the technical compatibility and safety of the ventilator in an MR environment, not on the comparative clinical effectiveness or improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The testing performed on the SERVO-i ventilator with the MR option can be considered "standalone" as it evaluates the device's technical performance and its interaction with an MRI system, without direct human-in-the-loop performance being a primary outcome measure for the MR compatibility. The ventilator itself is a standalone medical device.
7. The Type of Ground Truth Used
The ground truth used for this testing is based on:
- Engineering specifications and regulatory standards for MR compatibility: The device must maintain its intended ventilatory function.
- MRI image quality assessment: The device must not cause unacceptable artifacts in the MR images.
- Magnetic field strength measurements: To ensure safety margins.
This is a technical ground truth rather than a clinical ground truth derived from expert consensus or pathology in a diagnostic context.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device (ventilator) and its MR compatibility, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML algorithm or training set discussed in the provided document.
§ 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).