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The Sunmed Control Syringes is intended to inject contrast media or saline for angiographic procedures.

The Sunmed™ Control Syringes using dynamics principle, by means of the interference fit between the plunger with piston and the barrel, using the aspirating or driving force generated by manual function to draw or inject angiography medicament or saline for clinical disposable use.
The Sunmed™ Control Syringes is a single-use device that consists of two different structures: one is the standard type; the other is locking plunger type.
The volume of two type control syringes that to be offered in 10ml, 12ml.
The sunmed™ Control Syringes are available with rotating male luer and fixed male luer.
The sterilization method of the Sunmed™ Control Syringes is Ethylene Oxide sterilization.

This document is a 510(k) premarket notification for the Sunmed™ Control Syringes. It describes the device and claims substantial equivalence to predicate devices, but it does not describe a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document discusses "acceptance criteria" only in a very general sense, referring to standard non-clinical tests for medical devices like biocompatibility, sterility, and bench testing, to demonstrate substantial equivalence to a predicate device. There is no mention of an algorithm, AI, or software performance evaluation.

Therefore, I cannot provide the requested information regarding AI device performance, sample sizes, ground truth establishment, or expert involvement, as these elements are not present in the provided text.

Here's a breakdown of why I cannot fulfill the request based on the provided text:

• No AI or Algorithm: The device is a "Sunmed™ Control Syringes," a physical medical device intended to inject contrast media or saline. This is not an AI or algorithm-based device.
• No "Device Performance" in the AI sense: The document assesses physical characteristics (pressure rating, clarity, sterility, etc.) against predicate devices, not AI performance metrics like sensitivity, specificity, or AUC.
• No Study Design for AI: There's no mention of training sets, test sets, ground truth, expert adjudication, or MRMC studies, all of which are relevant to AI device evaluations.

The document's purpose is to demonstrate substantial equivalence for a physical device, not to evaluate an AI's diagnostic or predictive capabilities.

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