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510(k) Data Aggregation
(119 days)
The Essence 55SP Large Monitor System (Essence 55SP) 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 55SP 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. The system consists of a 55" TFT color LCD Monitor, and optionally a video wall controller, optical graphic extension module, a common PC, and cables.
The provided document is a 510(k) Summary for the Essence 55SP Large Monitor System. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain the kind of detailed study information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details for training/test sets) that would typically be found for an AI/ML medical device submission.
This document describes a medical monitor, not an AI/ML device. Therefore, the specific criteria requested, which are typically for assessing the performance of AI/ML algorithms against a clinical ground truth, are not applicable or present in this submission. The tests mentioned are performance tests for the display itself, ensuring it meets technical specifications and is equivalent to the predicate device.
Here's an attempt to answer the questions based on the available information, noting where the requested information is not present due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document compares the proposed device (Essence 55SP) with a predicate device (Essence 55S) based on technical specifications. The acceptance criteria essentially appear to be demonstrating "substantial equivalence" to the predicate device, meaning its technical performance is either the same or, if different, the difference does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (Essence 55SP) | Difference & Explanation |
|---|---|---|
| Panel Type: TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| Panel Size: 139.7 cm / 55" | 139.7 cm / 55" | - |
| Display Size (H x V): 1209.6 mm x 680.4 mm | 1209.6 mm x 680.4 mm | - |
| Pixel Pitch: 0.315 x 0.315 mm | 0.315 x 0.315 mm | - |
| Native Resolution: 3840 x 2160 pixels | 3840 x 2160 pixels | - |
| Display Colors: 1.07 billion colors | 1.07 billion colors | - |
| Viewing Angle (H,V): 178°, 178° | 178°, 178° | - |
| Brightness (Typ.): 560 cd/m² | 540 cd/m² | The same screen is used, but 55SP has additional glass, causing a slight brightness reduction. Deemed not to affect observer's performance. |
| Recommended Brightness for Calibration: 400 cd/m² | 400 cd/m² | - |
| Brightness Uniformity: DIN V 6868-57 | DIN V 6868-57 | - |
| Contrast Ratio (Typ.): 1400:1 | 1400:1 | - |
| Response Time: 6.5 ms (Midtone) | 6.5 ms (Midtone) | - |
| Scanning Frequency (H, V): 131.3 KHz, 59.5 – 60.5 Hz | 131.3 KHz, 59.5 – 60.5 Hz | - |
| Dot Clock: 257.4 MHz | 277 MHz | EDID is changed, which does not raise any new issue of substantial equivalence. |
| Input Terminals: DVI-D (dual link) x 2; DisplayPort x 2; DVI single link (HDMI) x 2 | DVI-D (dual link) x 2; DisplayPort x 2; DVI single link (HDMI) x 2 | - |
| Net Weight: 38 +/- 1 Kg | 49.5 +/- 2 Kg | The 55SP is with additional glass, hence the increased weight. Deemed not to affect observer's performance. |
| Dimensions (Unit:mm): 1287.2 x 761 x 85.6 mm | 1287.2 x 761.2 x 86.3 mm | The 55SP is with additional glass, hence the slightly different dimensions. Deemed not to affect observer's performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical monitor, and the "tests" performed are bench tests and display validation tests to confirm its technical specifications and equivalence to a predicate device. It does not process or analyze medical data in a way that would involve a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels or diagnoses. This device is a display system, not a diagnostic AI. Its performance is assessed against technical specifications, not clinical judgment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the sense of clinical cases requiring adjudication.
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
Not applicable. This device is a display monitor, not an AI system. It does not provide AI assistance for human readers, therefore, an MRMC study comparing human readers with and without AI would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance is based on meeting technical specifications as specified by standards and comparison to a predicate device's measured performance. There is no "ground truth" related to medical disease states as one would find in an AI/ML submission.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set or medical ground truth for this device.
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