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The Nipro SafeTouch PSV Scalp Vein Set with Safety Device is intended to insection into a patient's vascular system (for single use) as an indwelling device to administer fluids intravenously or to sample blood. Secondly, it is designed with an active sharp feature that requires physical action by the clinician to prevent needlestick incidents.

The SafeTouch PSV Scalp Vein Set with Safety Device is a safety intravascular administration set. It incorporates a safety mechanism that requires physical action by the clinician, to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries after use.

The basic structure of the device consists of a 25G X ¾ inch needle, needle hub with incorporated safety mechanism, wing unit, micro bore tubing, a clamp and female luer connector with cap. It is supplied sterile for single use only, non-pyrogenic, non-toxic, is not made with DEHP and does not contain natural rubber latex.

The provided document is a 510(k) Summary for a medical device (Nipro SafeTouch PSV Scalp Vein Set with Safety Device) and does not contain information about the development or validation of an AI/ML powered device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, data provenance, expert ground truth establishment, MRMC studies, standalone algorithm performance, or training set details as none of this information is present in the document.

The document states:

• "Clinical tests: This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission." This explicitly confirms that clinical validation studies (which would involve human readers and potentially AI assistance if it were an AI device) were not conducted.
• The tests conducted were "Non-clinical tests" focused on the physical and mechanical properties of the device (e.g., Gauging test, Liquid leakage test, Mechanical strength of unions, Flow rate, Penetration force of needle, Safety mechanism-Return force after locked, etc.). These are standard engineering and performance tests for medical hardware, not AI model validation.
• The purpose of this submission is to demonstrate "substantial equivalence" to a predicate device (Nipro SafeTouch Scalp Vein Set - K011297) based on physical characteristics, operational mode, basic scientific technology, and intended use, verified through non-clinical performance testing.

In summary, the request for information on AI/ML validation studies cannot be fulfilled from this document because it describes a traditional medical device, not an AI/ML-powered one.

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