(122 days)
The Essence 55S Large Monitor System (Essence 55S) is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.
The Essence 55S Large Monitor System is a large color LCD monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. Thanks to the advantages of the large widescreen monitor, the data can be collected from the video sources using the optional video wall controller AVS-540 and fed into the large display via the DVI lines and / or DP. The optical graphic extension module M1-201SA-TR can be used to convert / transmit the video signal, and the common PC can be taken as a video device.
The provided 510(k) summary (K172969) describes a medical monitor, the Essence 55S Large Monitor System. The acceptance criteria and the study that proves the device meets them are based on comparisons to a predicate device and bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical monitor, and its "performance" is primarily defined by its technical specifications and its ability to integrate video output for medical professionals. The acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and successful bench and system tests.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Essence 55S) |
|---|---|---|
| Intended Use | Same as predicate device. | "The intended use of Essence 55S Large Monitor System (Essence 55S) is totally same as that of the predicate device." |
| Technological Characteristics | Equivalent to predicate; differences do not affect safety/effectiveness. | Demonstrated through detailed comparison table (Table 2) and the conclusion that "technological characteristics differences do not affect the safety and effectiveness, no new risk is raised." |
| Display Characteristics | Equivalent to predicate. | "The test results showed that the Essence 55S Large Monitor System is with display characteristics equivalent to those of the predicate device, RadiForce Large Monitor System except some items, each of which was determined that it would not affect observer's performance." |
| Safety & Effectiveness | No new risks introduced. | Concluded that differences "do not affect the safety and effectiveness, no new risk is raised." |
| Performance Testing | Successful completion of Display bench, validation, and system tests. | "The following tests were successfully performed to validate the Essence 55S Large Monitor System: Display bench tests, Display validation tests, System tests." |
Comparison Table for Key Technical Specifications (Excerpt from Table 2 in document):
| Comparison Item | Proposed Device Essence 55S Large Monitor System | Predicate Device RadiForce Large Monitor System |
|---|---|---|
| Panel Type | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (MVA) |
| Panel Size | 139.7 cm / 55" | 143 cm / 56.2" |
| Native Resolution | 3840 x 2160 pixels | 3840 x 2160 (16:9 aspect ration) |
| Display Colors | 1.07 billion colors | 16.77 million colors |
| Brightness (Typ.) | 560 cd/m² | 450 cd/m² |
| Recommended Brightness for Calibration | 400 cd/m² | 300 cd/m² |
| Contrast Ratio (Typ.) | 1400:1 | 1200:1 |
| Response Time (Typ.) | 6.5 ms (Midtone) | 6.5 ms (Midtone) |
2. Sample Size Used for the Test Set and Data Provenance
This is a medical display device, not an AI or diagnostic imaging device. Therefore, the concept of a "test set" in the context of patient data or clinical images is not applicable. The "tests" performed are engineering and performance validation tests.
- Sample Size: Not applicable in the context of patient data. The "sample" would be the device itself (Essence 55S Large Monitor System).
- Data Provenance: Not applicable. The "data" are technical specifications and test results generated from the device in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of expert consensus on medical images, is not relevant for a medical display device. The "ground truth" for this device's performance is its adherence to technical specifications and safety standards, as verified through engineering tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers in interpreting medical images. This device is a display, not an interpretation tool.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic devices or AI algorithms that assist in interpretation, to measure the impact of the device on human reader performance. This device is a monitor, not an interpretative aid.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, but not in the typical sense of an "algorithm-only" performance for a diagnostic task. The "standalone" performance here refers to the device's technical specifications and functionality as a display system, independent of a human's diagnostic interpretation using the displayed images. The "Display bench tests," "Display validation tests," and "System tests" are essentially standalone performance evaluations of the monitor.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Technical Specifications: Adherence to defined physical and electrical parameters (e.g., resolution, brightness, contrast, response time).
- Regulatory Standards: Compliance with relevant medical device safety and performance standards (e.g., EN60601-1, ANSI/AAMI ES60601-1, FCC-B, RoHS).
- Predicate Device Equivalence: The performance and characteristics of the legally marketed predicate device (RadiForce Large Monitor System) serve as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware display system, not a machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).