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The EVIS EXERA 160A system consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

EVIS EXERA Xenon Light Source Olympus CLV-160A: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA Video System Center Olympus CV-160A: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5, XGIF-H160Y2: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

EVIS EXERA Colonovideoscope XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).

The EVIS EXERA 160A System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

The primary components of the subject system, which are part of this submission, are:

• EVIS EXERA Xenon Light Source Olympus CLV-160A,
• EVIS EXERA Video System Center Olympus CV-160A,
• EVIS EXERA Gastrointestinal Videoscopes XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2.
• EVIS EXERA Colonovideoscopes XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L

The EVIS EXERA Xenon Light Source Olympus CLV-160A is intended for endoscopic diagnosis, treatment and video observation. The CLV-160A is basically identical to the predicate device, EVIS Universal Light Source CLV-U40, with the exception that the CLV-160A has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI) employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A. In comparison to conventional white light observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

The EVIS EXERA Video System Center Olympus CV-160A is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-160A Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images.

The provided document is a 510(k) summary for the Olympus EVIS EXERA 160A System, which is a premarket notification to the FDA for medical devices. This type of document is intended to demonstrate substantial equivalence to a predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study with quantitative performance metrics.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way you've outlined for things like AI/ML models. It focuses on demonstrating that the new device is as safe and effective as previously cleared devices.

Here's why your requested information isn't present in this type of submission and what information is available:

• Acceptance Criteria and Reported Device Performance: This document describes comparisons of specifications between the new device and its predicate devices (Tables 16-3 to 16-10). It highlights similarities in intended use, specifications, performance, and materials, with the key difference being the addition of the Narrow Band Imaging (NBI) function. It asserts that the clinical literature supports the safety and efficacy of NBI imaging in endoscopy, but it does not provide a specific table of acceptance criteria a new study had to meet for the overall system or its NBI function.
• Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth: These details are typically associated with performance studies, especially for new diagnostic algorithms or AI/ML components. The provided document is for a hardware system (endoscopic video imaging system) and focuses on demonstrating substantial equivalence through comparison to existing products and referencing existing clinical literature. It does not describe a specific clinical performance study with these parameters for the EVIS EXERA 160A System itself. The NBI function is presented as an additional feature, and its safety and efficacy are supported by "clinical literatures" (plural), implying existing published research rather than a de novo study conducted for this 510(k).

Conclusion from the document:

The conclusion explicitly states: "When compared to the predicate devices, the EVIS EXERA 160A System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the system." This is the core of a 510(k) submission – to show that the new device is substantially equivalent to already legally marketed devices, rather than establishing entirely new performance metrics via a dedicated study.

In summary, the provided 510(k) summary is not a clinical study report that would answer your specific questions about acceptance criteria and performance study details. It is a regulatory submission for substantial equivalence.

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