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Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.

The provided document is an FDA 510(k) premarket notification for an Insulin Syringe. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device, which is implied by your detailed request.

The document describes typical non-AI medical device testing, such as:

• Bench Testing: Verifies physical performance characteristics (e.g., needle tube length, bond strength, leakage, fit of plunger, dead space, penetration force, particulate contamination).
• Biocompatibility Testing: Assesses biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogens).
• Sterilization and Shelf-life Testing: Validates sterilization method and confirms shelf life.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria, performance metrics (like sensitivity, specificity, AUC), sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or training set details because this information is not present in the provided text. The device in question is a physical insulin syringe, not an AI/ML-based diagnostic or therapeutic device.

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