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These endoscope nozzle replacement kits are intended for use in replacing the nozzle on 43 models of Olympus America, Inc. gastroscopes and colonoscopes.

Each kit includes 6 nozzles, three set screws, sealant, and the necessary tools (#1 screw driver, tweezers, and magnifying glass) to replace the nozzle. Each kit will include only the nozzle size(s) and set screw size(s) appropriate for use with the Olympus of America, Inc. endoscope models currently being used by the purchaser.

This is a 510(k) premarket notification for "Endoscope Nozzle Repair Kits." This document describes a medical device, but it does not contain any information about acceptance criteria, performance studies, or clinical data in the way your request specifies.

The provided text is a summary prepared for a regulatory submission rather than a study report. It focuses on demonstrating "substantial equivalence" to a predicate device, which is a common pathway for medical devices that are similar to already legally marketed devices.

Here's why the requested information cannot be extracted from this text:

• No new performance claims: The document doesn't claim a new diagnostic or therapeutic performance for the device. It's a repair kit for an existing device.
• Focus on substantial equivalence: The core of the submission is to show that the replacement parts (nozzles, set screws, sealant) are functionally equivalent to the original manufacturer's parts. This typically relies on material compatibility, design similarity, and intended use, rather than clinical performance studies.
• No AI or diagnostic component: This is a physical repair kit, not a device that generates diagnostic output or uses AI. Therefore, concepts like receiver operating characteristics (ROC), sensitivity, specificity, ground truth, or expert review are not applicable.
• No "study" in the clinical sense: The text mentions "experience...has demonstrated that nozzle replacement is easily performed," but this is an observation from repair experience, not a structured clinical study with a protocol, endpoints, and statistical analysis as would be required for a diagnostic or therapeutic device.

Therefore, I cannot provide the requested table or details about acceptance criteria and performance studies because the provided text does not contain that information. This type of information would be found in a different section of a 510(k) submission, particularly for devices making performance claims (e.g., software as a medical device, new diagnostic tests) or for devices undergoing PMA (Premarket Approval) which requires extensive clinical trials.

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