(60 days)
The E240AG LCD Monitor is intended to provide 2D color video displays of images from surgical endoscopic/ laparoscopic camera systems and other compatible medical imaging systems. The E240AG is a widescreen, high definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
The E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 23.8-inch widescreen LCD display panel and employs full WUXGA high-definition (HID) performance. In addition to digital signals, the E240AG accepts analog signals and converts them to digital signals. The E240AG LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.
This document describes the premarket notification (510(k)) for the E240AG LCD Monitor and its variants, which are medical display monitors. The provided text does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of clinical outcomes. Instead, it details the submission for a medical monitor and its substantial equivalence to a predicate device based on technical specifications and safety standards.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not available in this document.
However, I can extract the relevant information pertaining to the device (medical monitor) performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table for this specific device. Instead, it compares the proposed device's specifications to a predicate device and reports compliance with recognized standards. The "performance data" section details bench testing conducted to ensure the device meets certain display and safety characteristics.
| Feature | Predicate Device (Sony LMD-2451MT, K113203) | Proposed Devices (E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor) | Reported Performance (via Bench Testing) | Discussion of Differences (if any) |
|---|---|---|---|---|
| Display Specifications | ||||
| Screen technology | 24" TFT LCD Panel | 23.8" TFT LCD Panel | - | Same (TFT LCD Panel) |
| Viewing angle (H, V) | Horizontal 178°, Vertical 178° (contrast ratio ≥ 10:1) | Horizontal 178°, Vertical 178° (contrast ratio ≥ 10:1) | - | Same |
| Resolution | 1920 x 1200 | 1920 x 1080 | - | Different due to panel size; however, this difference is implicitly deemed not to affect safety or effectiveness given the substantial equivalence conclusion. |
| Display area | 518.4 x 324.0 mm | 527.04 x 296.46 mm | - | Different due to panel size; implicitly deemed not to affect safety or effectiveness. |
| Contrast Ratio (typ) | 1000:1 | 1000:1 | - | Same |
| Recommended brightness | 300cd/m² | 300cd/m² | - | Same |
| Pixel Pitch | 0.27 x 0.27 mm | 0.27 x 0.27 mm | - | Same |
| Backlighting | LED backlight | LED backlight | - | Same |
| Grayscale | 1024 | 1024 | - | Same |
| Response time | 14ms | 14ms | - | Same |
| Sensor | Backlight sensor | Backlight sensor | - | Same |
| Input/Output Signals | ||||
| Input signals | BNC, DVI, SDI, Y/C (S-Video), YPbPr, RGBS, HD15 | VGA, DVI-A/D, SDI, Y/C (S-Video), YPbPr, RGBS, CVBS | - | Differences in signal interface types (E240AG has VGA & CVBS). Stated as "nothing to do with the display function." |
| Input terminational | 1 DVI-D Dual Link, 1 HDMI Port | 1 DVI-D Dual Link, 1 HDMI Port | - | Same |
| Output signals | BNC, DVI, SDI, Y/C (S-Video), YPbPr, RGBS, HD15 | DVI-D, SDI, Y/C (S-Video), YPbPr, RGBS, CVBS | - | Differences in signal interface types (E240AG has CVBS). Stated as "nothing to do with the display function." |
| Electrical/Physical | ||||
| Power Requirement | 100 V - 240 Vac ±10%, 50/60 Hz 1.53 A - 0.58 A | 100 - 240 Vac ±10%, 47-63 Hz 1.4 - 0.6A | - | Same (in terms of voltage range), minor differences in frequency range and current. |
| Power Consumptions/Save Mode | 125W / less than 0.7W | 35W / less than 0.5W | - | Differences due to adapter and components; lower consumption for E240AG. Stated as "nothing to do with the display function." |
| Dimensions w/o stand (W x H x D) | 602.4 x 386.2 x 110 mm | 565.3 x 65 x 375.3 mm | - | Different housing design due to different panel size; implicitly deemed not to affect safety or effectiveness. |
| Applicable Standard Compliance | IEC 60601-1:1988+A1:1991+A2:1995; IEC 60601-1-2 Ed 3:2007 | IEC 60601-1:2012; IEC 60601-1-2:2014 | Device complies | Same (updated versions of standards applied) |
| Intended Use | 2D and 3D color video displays from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. For real-time use in ORs, surgical centers, clinics, offices. | 2D color video displays from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. For real-time use in ORs, surgical centers, clinics, offices. | - | The proposed device is only for 2D, while the predicate also offered 3D. This difference is not discussed as affecting substantial equivalence, implying it's either an acceptable difference or within the scope of intended use. |
Performance Data and Study:
The study conducted was a bench test to demonstrate compliance with recognized standards.
- Measurement of the luminance non-uniformity characteristics of the display screen.
- Measurement of the chromaticity non-uniformity characteristics of the display screen.
- Measurement of contrast ratio.
- Performance data on luminance stability.
- Electrical safety and electromagnetic compatibility (EMC) testing.
2. Sample size used for the test set and the data provenance: Not applicable. This is a technical performance test of hardware, not a clinical study involving a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance like luminance, contrast, and electrical safety is established through engineering specifications and objective measurements, not expert radiologists reviewing images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For display characteristics (luminance, contrast, chromaticity, luminance stability), the "ground truth" would be established by the industry standards and specifications the device aims to meet. For electrical safety and EMC, the ground truth is defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards. It's objective, quantitative measurement against engineering standards, not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Conclusion from document: The manufacturer concluded that the E240AG LCD Monitor is substantially equivalent to the predicate device (Sony LMD-2451MT) based on similarities in overall purpose, function, technical characteristics, performance, application, and intended use. The bench testing demonstrated compliance with applicable safety and performance standards (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that animal or clinical studies were not required to support substantial equivalence.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.