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The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.

The Sterile Hypodermic Syringe for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of a hypodermic needle and a luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle gauge (refer to Table 1).

The provided document is a 510(k) Summary for a Sterile Hypodermic Syringe with needle for Single Use. This type of device is a physical medical instrument, not a software or AI/ML-based device.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device
• Study data proving an AI/ML device meets acceptance criteria
• Sample sizes for test sets (in the context of AI/ML)
• Number of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Training set details (sample size, ground truth establishment)

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical tests (e.g., biological evaluation, sterility, mechanical performance) and comparison of technical characteristics, as summarized in the "Non-Clinical Test Conclusion" and "Substantially Equivalent (SE) Comparison" sections.

In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and performance study as requested. It pertains to a physical medical device.

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