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Single use, sterile, intended use for the subcutaneous injection of U 100 Insulin only.

"Bio-Med® Soft" Insulin syringe are sterile, single use, disposable hypodermic syringes with a permanently affixed lumen needle to the tip of syringe. The syringe consists of a barrel, a plunger rod with Synthetic Rubber Gasket, and an orange colored end-cap over the needle to preserve sterility of the fluid path. In addition the "Bio-Med® Soft" Insulin syringe are non-toxic and pyrogenic free "Bio-Med® Soft" Insulin syringe are available 1.0cc (100units), 0.5cc (50units), 0.3cc (30 units) with 29G, 30G, 31G, needle thickness, 1/2:'', 5/16'' needle length, and meet the following standard: ISO 7864 Sterile, Hypodermic Needles for single use ISO 8537: 1991/Amendment 1: 2000 Sterile, Single use Syringe with/without needle For insulin

This document does not contain an AI/ML device. The provided text is a 510(k) premarket notification for the "Bio-Med® Soft Insulin Syringe," which is a traditional medical device (a piston syringe) and not an AI/ML product.

Therefore, I cannot extract information related to AI/ML device acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested. The document focuses on demonstrating substantial equivalence to predicate insulin syringes based on design, materials, manufacturing processes, and intended use, rather than algorithmic performance.

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