(58 days)
The 4K UHD LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic camera systems and other compatible medical imaging systems. The 4K UHD LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel. Liquid crystal and color filters are laid on the front of the flat light source (backlight) of the LCD panel. The LCD panel displays images by controlling the aperture of the liquid crystal according to input signals.
This document describes a 510(k) premarket notification for the Olympus 4K UHD LCD Monitor (Model Number: OEV321UH). The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, the Sony LMD-X310S LCD Monitor (K150377).
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses primarily on demonstrating substantial equivalence based on technical characteristics and performance testing rather than defining specific diagnostic performance acceptance criteria for human interpretation, as this is a display monitor, not a diagnostic algorithm.
The table below summarizes the technical characteristics comparison between the subject device and the predicate. The "Acceptance Criteria" for the subject device is implied to be "equivalent to or better than the predicate device" or "meeting relevant electrical and safety standards."
| Feature/Technological Characteristics | Subject Device (Olympus OEV321UH) | Predicate Device (Sony LMD-X310S) | Reported Device Performance (OEV321UH) | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Regulatory | ||||
| Device Name | Olympus 4K UHD LCD Monitor | Sony LCD Monitor | Olympus 4K UHD LCD Monitor | Equivalent Device Name Category |
| Product Code | GCJ (Same as predicate) | GCJ | GCJ | Same Product Code |
| Regulatory Class | II (Same as predicate) | II | II | Same Regulatory Class |
| Regulation Number | 876.1500 (Same as predicate) | 876.1500 | 876.1500 | Same Regulation Number |
| Regulation Name | Endoscope and accessories (Same) | Endoscope and accessories | Endoscope and accessories | Same Regulation Name |
| Classification Panel | General and Plastic Surgery (Same) | General and Plastic Surgery | General and Plastic Surgery | Same Classification Panel |
| Indications for Use | Provides 4K 2D color video | Provides 4K 2D color video | Provides 4K 2D color video | Substantially Equivalent Indications for Use |
| Mode of Action | Same as predicate | Displays color video images on LCD | Displays color video images on LCD | Same Mode of Action |
| Intended Environment | Same as predicate | Hospital operating rooms, etc. | Hospital operating rooms, etc. | Same Intended Environment |
| Intended Users | Same as predicate | Doctors and Assistants | Doctors and Assistants | Same Intended Users |
| System Parameters & Specifications | ||||
| Power | Same as predicate | AC 100-240V/ 50-60Hz | AC 100-240V/ 50-60Hz | Equivalent Power Specifications |
| Dimensions (excluding max. protrusions) | 753.9 × 476.3 × 79.2 mm | 753.8 × 456.4 × 69.3 mm | 753.9 × 476.3 × 79.2 mm | Comparable (minor differences noted as acceptable) |
| Display Dimension | Same as predicate | 2D | 2D | Same Display Dimension Type |
| Input Signals | 12G-SDI1, 12G-SDI2, 3G-SDI, | DVI-D, HDMI, 3G/HD/SD-SDI | Increased range of digital inputs. | Functionally equivalent or improved digital input capability. |
| DisplayPort, HDMI, DVI-D, DC IN | ||||
| Output Signals | 12G-SDI1, 12G-SDI2, 3G-SDI, | DVI-D, 3G/HD/SD-SDI | Increased range of digital outputs. | Functionally equivalent or improved digital output capability. |
| CloneOUT, +5V DC OUT, +12V DC OUT | ||||
| Display Device | Same as predicate | LCD panel (IPS) | LCD panel (IPS) | Same Display Device Technology |
| Backlight Device | Same as predicate | LED | LED | Same Backlight Technology |
| Viewing Angle | Same as predicate | Right/Left/Up/Down >89° (CR>10) | Right/Left/Up/Down >89° (CR>10) | Equivalent Viewing Angle Performance |
| Active Screen Size | 697(H)×392(V) mm | 697.958(H)×368.064(V) mm | 697(H)×392(V) mm | Comparable (minor differences noted as acceptable to display 4K) |
| Resolution | 3840 × 2160 pixels | 4096 × 2160 pixels | 3840 × 2160 pixels | Substantially equivalent (both are 4K UHD resolutions) |
| Luminance | ≥280 [cd/m²] | ≥550 [cd/m²] | ≥280 [cd/m²] | Within acceptable limits for medical monitors. |
| Primary Colors | Same as predicate | RGB | RGB | Same Primary Colors |
| Gamma Curve | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, | HLG setting available on subject device. | Equivalent or improved range of gamma settings. |
| Endoscope, HLG | Endoscope, Highlight | |||
| Color Space | Same as predicate | Auto, BT.709, BT.2020, Native | Auto, BT.709, BT.2020, Native | Same Color Space Options |
| Refresh Rate | Same as predicate | 50/60Hz | 50/60Hz | Same Refresh Rate |
| Frame Rate | Same as predicate | 50/60 fps | 50/60 fps | Same Frame Rate |
| Display Format | Same as predicate | Normal, Multi display, Flip display | Normal, Multi display, Flip display | Same Display Format Options |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a technical and performance verification and validation testing program as outlined in the "Summary of Performance Testing" section of the 510(k) submission.
- Electrical Safety and Electromagnetic Compatibility (EMC): The device was confirmed to be in compliance with ANSI AAMI ES 60601-1:2005+A1:2012 (general requirements for basic safety and essential performance) and IEC60601-1-2:2014 (EMC requirements).
- Software Verification and Validation Testing: This was performed and documented in compliance with FDA guidance for software in medical devices and cybersecurity.
- Risk Analysis: A risk analysis was conducted in accordance with ISO 14971, which identified design verification tests and acceptance criteria.
- Human Factors Validation Testing: Performed in accordance with FDA Guidance, this assessed applicable adverse events and reviewed overall risk analysis to confirm no unacceptable user-related residual risk.
The submission states that the 4K UHD LCD Monitor OEV321UH "has been verified and validated to be equivalent in electrical performance for displaying images from endoscopic camera systems and other compatible medical imaging systems, when compared to the predicate." The differences in system parameters (dimensions, input/output, active screen size, resolution, luminance, gamma curve) were reviewed via a risk-based assessment, which "did not identify any new risks or significantly modified existing risks, or raise new or different questions with respect to safety and effectiveness."
This is a submission for a medical display monitor, not an AI or diagnostic algorithm, so many of the requested items (e.g., sample size for test set, ground truth experts, MRMC study, training set) typically associated with AI/algorithm efficacy studies are not applicable in the same way.
Below are the answers to the specific questions, with "N/A" where not applicable to this type of device and submission.
2. Sample size used for the test set and the data provenance
- Sample Size: N/A for a typical "test set" as defined for algorithm performance. The testing involved a single device (the Olympus 4K UHD LCD Monitor, Model OEV321UH) undergoing electrical safety, EMC, software, and performance verification tests.
- Data Provenance: N/A. The "data" here would be test results from specific technical standards and internal verification protocols, not patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth, in the context of image interpretation by experts, is not relevant for a display monitor's technical performance verification. The "ground truth" here is compliance with established engineering and safety standards.
4. Adjudication method for the test set
- N/A. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human readers on clinical cases. This is not applicable to technical compliance testing of a monitor.
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
- No. An MRMC study is not relevant for a medical display monitor as it's not an AI-powered diagnostic tool. The device is a passive display for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While the monitor operates standalone (i.e., it doesn't require a human to perform its basic function of displaying an image), this question typically refers to the standalone performance of an AI algorithm. In that context, no such study was done as this is not an AI algorithm. The device's standalone performance was demonstrated through technical verification and validation against engineering specifications.
7. The type of ground truth used
- The "ground truth" for this device's performance is adherence to established international and national electrical safety, electromagnetic compatibility, software validation, and risk management standards (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 14971, and FDA guidance on software and human factors). It's essentially engineering and regulatory compliance standards.
8. The sample size for the training set
- N/A. This is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. Since there is no training set, this question is not applicable.
§ 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.