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The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.

Also, the VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with rhinolaryngeal stroboscopes, is intended to observe the intralaryngeal phenomenon of phonation (speech) for endoscopic observation to examine the correct functioning of the vocal apparatus (glottis) and to examine voice disorders.

The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables efficient operation to meet the clinical needs of the ENT field; the device has been cleared by FDA for use with OLYMPUS urology/gynecology endoscopes (including CYF-VH, CYF-VHR, URF-V2, URF-V2R, URF-V3. URF-V3R. WA2T400A. WA2T412A. WA2T430A. WA2T43WA. WA2T470A. WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, CYF-5, CYF-5R, URF-P6, URF-P6R, URF-P7, URF-P7R and HYF-XP) under K241371.

The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head.

The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500) with Foor Holder (MAJ-2552), and five (5) optional accessories: an HDMI cable (MAJ-2551); the OTV-S500 Upgrade Pack Strobe (MAJ-2547), which activates the stroboscopy function of the OTV-S500; an Air Microphone (MAJ-2548); a Throat Microphone (MAJ-2549); and the Microphone Extension Cable (MAJ-2550).

The OLYMPUS OTV-S500 is compatible with the following OLYMPUS ENT endoscopes: ENF-VH, ENF-VH2, ENF-V3, ENF-V4, ENF-VT3, ENF-XP, ENF-GP2, WA4KS400, WA4KS430, WA4KS431, WA4KS445, WA4KS446, WA4KS471, WA4KS471, WA96100A and WA96105A.

The provided text is a 510(k) Summary for the OLYMPUS OTV-S500 (VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500).

The 510(k) Summary states that no clinical data were collected to support the performance of the subject device. Therefore, a study proving the device meets acceptance criteria in a clinical setting is not available from this document.

However, the document does describe non-clinical performance data and acceptance criteria based on standard compliance and specified tests.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly mentions performance testing, but does not provide specific acceptance criteria in numerical or qualitative form alongside reported device performance for each criterion. Instead, it states that "all testing passed/met the acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document refers to "Performance Testing Bench" with the subject device and compatible endoscopes, but does not specify the number of devices or endoscopes tested. Data provenance (country of origin, retrospective/prospective) is also not mentioned for the non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described tests are non-clinical, bench-top performance, electrical safety, and software validation tests, which do not typically involve human expert establishment of ground truth in the same way clinical or diagnostic studies do. The "truth" for these tests comes from objective measurements against defined standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed for ground truth.

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 MRMC study was done. The document explicitly states: "No clinical data were collected to support performance of the Subject device." The device itself is a video system center for endoscopes, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of an "algorithm only" performance. The OLYMPUS OTV-S500 is a hardware device (video system center) with embedded software. The software validation tests mentioned would assess the functionality and safety of the embedded software itself, which is part of the device's standalone operation. However, this is not a standalone "algorithm" in the typical sense of a diagnostic AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests described, the "ground truth" or reference for performance is established by technical standards and specifications. For instance:

• Performance Testing Bench: ISO standards (e.g., ISO 8600-3:2019 for Field of View, ISO 15739:2017 for Image Noise and Dynamic Range), and internal product specifications (e.g., for Brightness, Latency, etc.). The FDA Color Performance Review (CPR) Tool for Endoscopy Devices would provide a standard reference for color analysis.
• Electrical Safety/EMC Testing: Compliance with various IEC/ANSI AAMI standards (e.g., ES60601-1, IEC 60601-1-2).
• Software Validation/Cybersecurity: Compliance with IEC 62304, ISO 14971, and FDA guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. As no clinical data was collected and the device is a hardware system with embedded software, there's no mention of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable due to the absence of a training set as described above.

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