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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 endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS DUODENOSCOPE with an instrument channel with a minimum diameter of @4.2mm.

The XCHF-B180Y1, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct. The XCHF-B180Y1 is basically identical to the predicate device, Olympus XCHF-BP Type 160F Choledochoscope, hereinaffer referred to as XCHF-BP160F in intended use, specifications, performance. The optical system of the XCHF-B180Y1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

The provided document is a 510(k) premarket notification for a medical device, the OLYMPUS XCHF-B180Y1 Choledochoscope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical study to establish acceptance criteria and performance against those criteria. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them.

Here's a breakdown of why the requested information is absent based on the document:

• No acceptance criteria or device performance table: The document's closest equivalent to a performance table is the "Comparison of Specifications" (Table 13-2) which compares the subject device's technical specifications (e.g., Field of View, Depth of Field, Outer Diameter) to a predicate device. This is not a comparison of clinical performance or a statement of acceptance criteria for clinical outcomes.
• No mention of a test set, data provenance, experts, or adjudication method: These elements are characteristic of a clinical study designed to evaluate device performance against specific endpoints, which is not what a 510(k) submission typically requires for substantial equivalence. The document is comparing technical specifications and intended use.
• No MRMC comparative effectiveness study: The document does not describe any human reader study or any comparison of human readers with or without AI assistance. The device is an endoscope, not an AI-powered diagnostic tool.
• No standalone algorithm performance: As stated, this is a physical medical device (an endoscope), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
• No type of ground truth mentioned: Ground truth is established for clinical endpoints, which are not being assessed in this 510(k) comparing technical specifications for substantial equivalence.
• No sample size for the training set or how ground truth was established for it: Again, these are concepts relevant to algorithm development and validation, not the submission for a physical endoscope demonstrating substantial equivalence.

In summary, the provided 510(k) document is for a traditional medical device (a choledochoscope) and demonstrates substantial equivalence by comparing its technical specifications and intended use to a legally marketed predicate device. It does not include information about clinical acceptance criteria or a study designed to prove the device meets such criteria.

The core of this 510(k) is found in "Table 13-2. Comparison of Specifications" and the accompanying text: "The XCHF-B180Y1 is similar to the predicate device XCHF-BP160F in specifications except for the material and optical system." and "When compared to the predicate device, the XCHF-B180Y1 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This is the "proof" the device meets the criteria for substantial equivalence, which is the regulatory hurdle for a 510(k), not a direct clinical performance study.

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