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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."

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.

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The 4K UHD Laparoscope is intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.

The 4K UHD Laparoscope is a rigid endoscope, which consists of lighting system and optical imaging system. The 4K UHD Laparoscope has 12 models which are available in two insertion portion widths (5.5 mm and 10 mm), four working lengths (290mm, 300mm, 320mm) and three different directions of view (0°, 30°, 45°). The 12 models are all connected with adaptor 2 for different brand source light. The 4K UHD Laparoscope can be connected to Scivita 4K UHD Camera System, Scivita LED Light Source or Wolf light source and SONY Monitor. The 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.

The provided text describes the acceptance criteria and the study that proves the device meets them, specifically for the "4K UHD Laparoscope" (K203255).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly present a table of acceptance criteria with reported device performance in the typical sense of numerical thresholds and corresponding results for each. Instead, it describes adherence to recognized standards and qualitative comparisons to a predicate device. The performance is implied by the successful completion of these tests and the determination of substantial equivalence.

However, based on the non-clinical tests mentioned, we can infer some performance aspects and how "acceptance" was framed:

The study described is a non-clinical test program designed to compare the proposed device's performance against recognized standards and a legally marketed predicate device ("ULTRA" Telescopes, K150633, from Olympus Winter & Ibe GmbH). The goal was to establish Substantial Equivalence (SE).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document. The non-clinical tests typically involve a sample of the manufactured device models.
• Data Provenance: The tests were conducted by Scivita Medical Technology Co., Ltd. (based in China, as per the sponsor identification) as part of their 510(k) submission. The data is prospective from these internal tests.

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. This device is a hardware laparoscope, and the performance assessment is based on physical and optical measurements against engineering standards and comparison with a predicate device, not on expert interpretation of output data like medical imaging analysis. Therefore, there's no "ground truth" derived from medical experts in the context of diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Since the "test set" refers to physical and optical performance characteristics of the device itself (e.g., cytotoxicity, electrical safety, optical resolution, depth of field), expert adjudication methods typically used for interpreting diagnostic outputs (like imaging) are not relevant here. The evaluation involves compliance with established standards and direct measurement/comparison.

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. This document pertains to the clearance of a 4K UHD Laparoscope, which is a physical endoscopic device, not an AI-powered diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a hardware laparoscope. There is no algorithm to be tested in a standalone fashion.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests:

• Biocompatibility: Ground truth is defined by the absence of toxicity, irritation, or sensitization as per the criteria outlined in ISO 10993 standards.
• Electrical Safety & Performance: Ground truth is compliance with the requirements of IEC 60601-2-18.
• Endoscope Standards: Ground truth is compliance with the requirements of ISO 8600-1 and ISO 8600-5.
• Image Quality Performance: Ground truth is established by quantitative measurements (e.g., depth of field, geometric distortion) and comparison to the predicate device's performance, ensuring similar or improved characteristics that meet clinical needs.
• Sterilization Efficacy: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.

The overall "ground truth" for the submission is the determination of Substantial Equivalence to the predicate device based on these engineering and performance standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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