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Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.

Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.

Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.

Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.

This document is a 510(k) clearance letter for the Shina Safety Needle, a hypodermic single lumen needle. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about the acceptance criteria or a study that proves the device meets those criteria, nor does it include details about AI/ML performance, ground truth, or study methodologies that are typically found in a clinical study report or a more detailed section of a 510(k) submission.

The document focuses solely on:

• The FDA's decision regarding substantial equivalence.
• General regulatory requirements for the device.
• Indications for Use for the Shina Safety Needle.

Therefore, I cannot provide the requested information based on the input text. The information requested typically comes from performance testing reports, clinical studies, or AI/ML validation studies, none of which are detailed in this regulatory clearance letter.

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