(283 days)
The intended use of the Servo Screen 390 is to provide a central bedside location for the display of all parameter information from the ventilator in order to aid the clinician in quickly and accurately reviewing the operating state of the ventilator and the ventilatory status of the patient.
The Servo Screen 390 is a real time ventilatory monitor system that continuously reads and makes calculations from parameters measured or calculated by Servo Ventilators. It displays this information in a clear and logically organized manner. Parameters are listed in a numerical format and/or as waveforms and loops. All displayed parameters are trended in 3, 6, 12, or 24 hour intervals. The device consists of a small, compact computer unit suitable for use in the clinical environment designed specifically for integration with existing ventilators Servo Ventilator 300 and Servo Ventilator 900. The flat screen display unit measures 252 x 330 x 88 mm (not including control knob) and a flexible support arm. Weight including the support arm is 4.3 kg. When used with the Servo Ventilator 900, the Servo Computer Module 990 is required to interface the two devices. This interface mounts under the ventilator, adding 2.7 kg to the weight and 4.0 cm to the height.
This device (Servo Screen 390 and Servo Computer Module 990) is a ventilator monitoring system designed to display ventilatory data from existing Siemens Servo Ventilators. The provided text outlines a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information (like sample size, ground truth, expert qualifications, MRMC study, training set details) is not applicable or not available in this type of submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it focuses on demonstrating agreement with the ventilator display and meeting regulatory requirements.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Data Display Accuracy: The data displayed by the Servo Screen should be in agreement with the ventilator display. | "These tests demonstrated that the data displayed by the servo screen is in agreement with the ventilator display when ventilator operation is simulated over the operating range of key ventilator parameters." |
| Electromagnetic Compatibility (EMC): The device should meet requirements for immunity to electromagnetic interference and emissions of electromagnetic energy. | "The Servo Screen 390 and the SCM 990 have been tested and do meet the requirements for immunity to electromagnetic interference and emissions of electromagnetic energy as defined by EN60601-1-2." |
| Functionality (Data Visualization): Ability to display parameters, waveforms, loops, and trends from the ventilator. | "It displays this information in a clear and logically organized manner. Parameters are listed in a numerical format and/or as waveforms and loops. All displayed parameters are trended in 3, 6, 12, or 24 hour intervals." (This is a description of functionality rather than a specific test result). |
| Technological Equivalence: Similar technological characteristics and intended use to predicate devices. | The document extensively compares the Servo Screen to predicate devices (Leonardo, 7202 Display Option Module, Evita) demonstrating similar functions for storage, trending, and graphing of ventilator data, with differences primarily in implementation details. |
| Safety and Regulatory Compliance: Designed, manufactured, and maintained under GMP controls. | "The hardware and software are designed, manufactured, and maintained under GMP controls." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "ventilator operation is simulated over the operating range of key ventilator parameters." This suggests a functional testing approach without a defined "sample size" in the context of patient data.
- Data Provenance: Not applicable. The testing described is non-clinical, involving simulated ventilator operation, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. This was a non-clinical, engineering-focused validation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The testing involved comparing the device display to the ventilator display, which is a direct comparison rather than an adjudication process typically used with human interpretation.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a display system, not an AI-powered diagnostic tool, and the submission is a 510(k) for substantial equivalence to existing ventilator monitors, not a clinical effectiveness trial for a new therapeutic or diagnostic claim.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in an implicit sense. The "tests demonstrated that the data displayed by the servo screen is in agreement with the ventilator display" would represent a standalone functional test of the device's ability to accurately retrieve and display data from the ventilator without human intervention influencing the display accuracy itself.
7. The Type of Ground Truth Used:
- Ground Truth Type: The "ground truth" for the non-clinical tests was the direct output/display of the connected ventilator during simulated operation. The Servo Screen's display was compared directly against what the primary ventilator was reporting/displaying.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. The device is a display system, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set Establishment: Not applicable.
In summary, the provided document is a 510(k) summary for a ventilator monitoring system. The "study" described is a non-clinical validation focused on demonstrating functional accuracy of data display and electromagnetic compatibility against established standards and the output of the source ventilator. It does not involve patient data, expert interpretations, or AI/ML components requiring training sets or clinical effectiveness studies in the manner typically associated with diagnostic AI tools. The "acceptance criteria" are inferred from the demonstrated agreement with ventilator displays and compliance with regulatory standards.
§ 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).