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The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

The device is intended for single-use, and is supplied sterile, single-use air/water and suction valves help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single patient use item. The air/water valve is designed to be attached to the air/water port of the endoscope and the suction valve to the suction port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.

The provided document is a 510(k) premarket notification for the SmartStart™ Air/Water and Suction Valves. It aims to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, this document does not contain the information requested in the prompt regarding acceptance criteria and the comprehensive study details for a device meeting those criteria.

Specifically, the document focuses on demonstrating that the SmartStart™ valves perform similarly to already approved devices. It does not provide:

• A table of distinct acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the device's clinical performance.
• Details of a study proving the device meets specific performance acceptance criteria beyond basic physical and functional tests (like air/water flow and leakage).
• Information on sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for clinical efficacy.
• Details regarding training sets for an AI/algorithm-based device, as this is a medical device and not an AI-driven software.

The performance testing section (8.3) mentions "acceptance criteria for air flow, water flow and leakage," but it does not specify what those criteria are or provide detailed results from a study that quantifies the device's performance against these criteria. It simply states that the device "will perform in accordance with the acceptance criteria."

This type of submission relies on comparative analysis with existing predicate devices, focusing on technical characteristics, indications for use, and a limited set of non-clinical performance and safety tests (sterilization, shelf-life, biocompatibility, and basic functional tests).

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