(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.
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OCT 2 5 1996
r
510(k) Summary for Siemens Servo Screen 390
DATE THIS SUMMARY WAS PREPARED 1.
January 11, 1996
SUBMITTER'S NAME AND ADDRESS 2.
Siemens-Elema AB Röntgenvägen 2 S-171 95 Solna Sweden
3. CONTACT PERSON
Mr. Anders Lodin
| Telephone | 011-46 8 730 7228 |
|---|---|
| Telefax | 011-46 8 98 63 05 |
4. DEVICE NAME
| Trade/Proprietary Name: | Servo Screen 390 and Servo Computer Module 990 |
|---|---|
| Common Name: | Ventilator Monitoring System |
| Classification Name: | (Accessories to) Ventilator, Continuous (Respirator) |
5. PREDICATE DEVICES
The legally marketed devices to which equivalence is being claimed are:
- · LEONARDO Patient Data Manager Hamilton Medical P.O. Box 30008 Reno, NV 89520
1/11/96
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- 7202 DISPLAY OPTION MODULE Puritan-Bennett International, Inc. P.O. Box 25905 Overland Park, KS 66225
- EVITA Ventilator Dräger 4101 Pleasant Valley Road Suite 100 Chantilly, VA 22021
DEVICE DESCRIPTION 6.
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 flexible support arm makes it easy to place the screen in a wide array of positions; on the ventilator, on a cart, or even on a wall rail for maximum visibility. The front panel has an electro-luminescence monochromatic display screen and a single operator control in the form of a control-knob, which is simply turned or pressed.
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.
INTENDED USE 7.
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
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status of the patient. When review of the tabular or graphical data displayed on the Servo Ventilator 300 indicate that intervention may be required, it is the responsibility of the clinician to verify critical settings and measurements on the ventilator control panel and to obtain appropriate additional data from other sources before initiating changes in therapy.
The Servo Screen 390 does not control the ventilator, nor does it recommend specific changes in therapy or provide a diagnosis. It is a device for the formatting and display of data.
8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Servo Screen, Leonardo, 7202 Display Option Module, and Evita all provide for storage, trending, and graphing of data retrieved from the ventilator. All provide a video screen at the ventilator where the user can choose to view in real time a subset of the available parameters as tables, waveforms over time, or X-Y "loop" plots. Differences in the set of parameters available are due to differences in the ventilators, not the ventilatory monitoring system itself. Of the thirty parameters and graphs that can be displayed on the Servo Screen, fifteen are also available on the Leonardo. Of the fifteen not found on the Leonardo, three are found on the Puritan-Bennett 7202 Display Option Module (minute volume, tidal volume, and dynamic compliance), and one on the Dräger Evita (CO2 concentration). The remaining twelve parameters represent unique capabilities of the Siemens Servo Ventilators, rather than a substantial difference in the monitoring systems.
Servo screen uses an Intel 80486SX microprocessor, MS-DOS operating system, and displays data on an electroluminescent flat-panel display. The hardware and software are designed, manufactured, and maintained under GMP controls. The Leonardo system is an application program that runs on an IBM compatible personal computer and displays data on a CRT display. The Puritan-Bennett 7202 Display Module displays data on an electroluminescent display. The details of the processor hardware are not known to this applicant. The Dräger Evita includes the equivalent functionality as an integral part of the ventilator and displays data on an LCD display.
The differences in user interface, size & weight, and data formatting among the four systems reflect differing implementations of systems with the common goal of providing the convenient and user-friendly presentation for the user. While some clinicians may
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prefer one implementation over the others, we do not believe that these subjective differences have a significant effect on the clinical efficacy of the devices.
The SCM 990 Version 2 is a firmware upgrade to enable the data interface to provide a larger selection of ventilator parameters for display on the Servo Screen. The expanded list of available parameters is equivalent to the parameters which can be displayed on the predicate devices.
9. NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The design of the Siemens Model 390 Servo Screen has been thoroughly validated at the unit, integration and system level. Non-clinical tests were conducted of the Siemens Model 390 Servo Screen, interfaced to both the Servo Ventilator 900 and Servo Ventilator 300. 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. 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
10. CONCLUSIONS FROM NONCLINICAL TESTING
Based on inspection of the Servo Screen and Servo Computer Module Requirements Specifications and review of the testing that demonstrates that these requirements are met, we conclude that the Servo Screen 390 and the SCM 990 are substantially equivalent to the predicate devices cited 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).