(166 days)
The LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic / laparoscopic camera systems and other compatible medical imaging systems. The LCD Monitor is a wide-screen, 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 Sony LMD-X310S. LMD-X310MD and LMD-X310NB are 31 inches LCD monitors, and LMD-X550S. LMD-X550MD and LMD-X550NB are 55 inches LCD monitors with an advanced display technology, designed for use in medical environments. These monitors provide 4K resolution 2D color video displays of images from a surgical endoscope, laparoscopic camera system, and other compatible medical imaging systems. They are suitable for environments such as operating rooms. surgical centers, clinics, doctor's offices, and similar locations.
LMD-X310S、LMD-X310MD and LMD-X310NB are operated by DC power supply and supplied with a dedicated AC adaptor, AC-300MD. LMD-X310MD is SONY brand model, LMD-X310S is a model for a specified customer and LMD-X310NB is for unspecified customers.
MD-X550S, LMD-X550MD and LMD-X550NB are operated by AC power supply. LMD-X550MD is SONY brand model, LMD-X550S is a model for a specified customer and LMD-X550NB is for unspecified customers.
Key features include:
- A Large and 4K Screen
- Wide color qamut
- Clear and High-contrast View
- A.I.M.E.™ (Advanced Image Multiple Enhancer)
- Narrow Bezel
- Ergonomic Design
- User-friendly Control Panel
- A Variety of Display Format
- Easy to Clean
- Installation-friendly Cabling
This document describes the regulatory submission for Sony LMD-X310S, LMD-X310MD, LMD-X310NB, LMD-X550S, LMD-X550MD, and LMD-X550NB LCD Monitors. The submission focuses on demonstrating substantial equivalence to a predicate device, the SONY LMD-2451MT LCD MONITOR.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" with specific numerical values for performance metrics that the device had to meet. Instead, it states that the devices conformed to recognized standards and that bench testing "met pre-defined design and performance acceptance criteria."
The performance characteristics are largely presented in a comparative table with the predicate device, focusing on technological characteristics rather than specific "acceptance criteria" against which performance was measured.
Functional Performance Comparison (derived from Section 5.6):
| Feature/Characteristic | Subject Device Reported Performance (LMD-X310S/MD/NB and LMD-X550S/MD/NB) | Predicate Device Reported Performance (SONY LMD-2451MT LCD MONITOR) |
|---|---|---|
| Intended Environment | Hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments | Hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments |
| Intended Users | Doctors and assistants | Doctors and assistants |
| Compatibility | Surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems | Surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems |
| Power | AC 100-240 V/50-60 Hz | AC 100-240 V/50-60 Hz |
| Display Dimension | 2D | 2D / 3D |
| Input Signals | DVI-D, HDMI, 3G/HD/SD-SDI | DVI-D, HD15, RGB/Component, Y/C, Composite SDI 4:2:2 (optional) HD/D1-SDI (optional) NTSC/PAL :Y/C, Composite (optional) |
| Output Signals | DVI-D, 3G/HD/SD-SDI | Composite output connector Y/C output connector RGB/component output connectors External synchronized output connector |
| Display Device | LCD panel (IPS) | LCD panel (IPS) |
| Backlight Device | LED | CCFL |
| Viewing Angle | Right>89[deg] (CR>10) Left>89[deg] (CR>10) Up>89[deg] (CR>10) Down>89[deg] (CR>10) | Right>89[deg] (CR>10) Left>89[deg] (CR>10) Up>89[deg] (CR>10) Down>89[deg] (CR>10) |
| Active Screen Size (LMD-X310 models) | 697.958(H)×368.064(V) mm | - |
| Active Screen Size (LMD-X550 models) | 1209.573(H)×680.385(V) mm | - |
| Active Screen Size (Predicate) | - | 518.4(H)×324.0(V) mm |
| Resolution (LMD-X310 models) | 4096×2160 pixels | - |
| Resolution (LMD-X550 models) | 3840×2160 pixels | - |
| Resolution (Predicate) | - | 1920×1200 pixels |
| Maximum Luminance (LMD-X310 models) | ≥550[cd/m2] | - |
| Maximum Luminance (LMD-X550 models) | ≥330[cd/m2] | - |
| Maximum Luminance (Predicate) | - | ≥200[cd/m2] |
| Color Gamut | Avg. 135% of sRGB | Avg. 102% of sRGB |
| Picture Enhancement | A.I.M.E. function | NA |
| Refresh Rate (LMD-X310 models) | 50/60 [Hz] | - |
| Refresh Rate (LMD-X550 models) | 100/120 [Hz] | - |
| Refresh Rate (Predicate) | - | 50/60 [Hz] |
| Frame Rate | 50/60 [fps] | 50/60 [fps] |
| Display Format | Normal, Multi display, Flip display | Normal, Multi display, Mirror image |
| Performance Standards | ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 62304, ISO 14971 | IEC 60601-1, EN 60601-1-2, ISO 14971 |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing as part of required performance verification and validation activities" (Section 5.7) and states that "Results show that the subject device has met pre-defined design and performance acceptance criteria." However, it does not specify any sample size for the test set or the provenance of any data. The testing appears to be functional and safety testing of the device itself, rather than testing on a dataset of medical images.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission focuses on the safety and performance of a medical display monitor and its substantial equivalence to a predicate device, not on diagnostic accuracy based on expert interpretation of medical images. Therefore, no experts were used to establish ground truth for a test set of medical images, as such a test set is not described.
4. Adjudication Method for the Test Set
Not applicable. As no test set involving expert interpretation is described, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states: "No clinical data was collected to support substantial equivalence between the subject and predicate devices" (Section 5.8). Therefore, no MRMC study was performed, and no effect size for human reader improvement with AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an LCD monitor, a hardware device for displaying images, not an algorithm or AI system for image interpretation. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is implicitly defined by its ability to meet recognized performance and safety standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2) and pre-defined design specifications through functional bench testing. It's not related to medical image interpretations, pathology, or outcomes data, as this is a display device.
8. The Sample Size for the Training Set
Not applicable. As the device is a medical monitor and not an AI/ML algorithm, there is no training set involved.
9. How the Ground Truth for the Training Set was Established
Not applicable. Since there is no training set, this question is not relevant.
§ 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.