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The Glucopro syringe is intended for use in the subcutancous infusion of insuline to tast "Inte GlucoPro (K011120) or compatible infusion set is inserted into the subcutaneous tissue of the user and it is connected to the Glucopro Syringe. The insulin is infused from an external infusion pump.

The Glucopro Syringe is a medication reservoir placed within an infusion pump and attached to an infusion set for infusion of medicine solutions, such as insulin. The materials used for the components include: stainless steel; polypropylene; and, silicone. All of these materials are typically used in medical devices.

The provided text is a 510(k) summary for the Glucopro™ Syringe, a medical device intended for subcutaneous infusion of medicine solutions, such as insulin. This document does not contain information on acceptance criteria or a study proving device performance against such criteria. It is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data from a specific study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information based on the given text.

The document primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Product Code.
• Contact Information: Manufacturer and contact person.
• Date of Summary Preparation.
• Legally Marketed Substantially Equivalent Device (Predicate Device): Disetronic Medical Systems AG, 3.15mL cartridge.
• Description of Device: Materials used (stainless steel, polypropylene, silicone) and general function (medication reservoir within an infusion pump).
• Intended Use: Subcutaneous infusion of medicine solutions, such as insulin.
• Comparison of Technical Characteristics: Stating similarity to legally marketed devices.
• FDA Correspondence: Official letter acknowledging review and determination of substantial equivalence.
• Indications for Use Statement: Specifies the use with an external infusion pump and connection to an infusion set (e.g., Insta GlucoPro) inserted into subcutaneous tissue.

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