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It is intended for uses in any procedure in which the control of suction force is desired.

The Stryker Suction Regulator (SSR) controls the rate of suction from any product that requires suction control. It consists of an inlet tube with a suction adapter at the end, an outlet tube with a suction adapter at the end, and a handpiece. The handpiece controls suction by varying the amount of ambient air entering the tube set. As more air is let into the tube set, suction force at the inlet tube is reduced. As less air is let into the tube set, suction force is increased.

The provided text is a summary of safety and efficacy for a medical device (Stryker Suction Regulator) and does not contain information about acceptance criteria or a study proving that the device meets those criteria. Therefore, I cannot extract the requested information.

The document focuses on:

• Device Classification and Name: Listing various classifications and the proprietary name of the device.
• Device Description: Explaining how the suction regulator works.
• Material and Sterilization Standards: Mentioning biocompatibility testing (ISO 10993) and sterilization validation (AAMI ST 27, AAMI ST 32).
• Substantial Equivalence Claim: Stating that the device is equivalent to the "Arthrex Suction Regulator" and does not raise new issues.

There's no mention of specific performance metrics, acceptance thresholds, or a study that evaluates the device against such criteria.

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