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Sterile hypodermic single use syringe with needle or without needle:
The Sterile Hypodermic syringe with needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Sterile hypodermic safety syringe (clip type) for single use with needle or without needle:
The sterile hypodermic safety syringes for single use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. A fler injection, the anti-needle stick feature is manually activated to aid in the prevention of accidental needle stick injuries.

Sterile hypodermic safety syringes (needle retractable type) for single use with needle:
The needle retractable safety syringe is to be used for intra-muscular or subcutaneous injections into a patient and is intended to prevent needle stick injuries. Needle retractable safety syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.

Sterile hypodermic needle for single use:
The Sterile Hypodermic needle intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The syringe consists of a plunger & gasket that's fits tightly within a cylindrical tube called a barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take-in and expel liquid or gas through a discharge nozzle at the front (open) end of the barrel. The open end of the syringe may be fitted with a hypodermic needle, a nozzle or tubing to help direct the flow into and out of the barrel. It has three different models of syringe along with needle as below:

• 1. Sterile Hypodermic Syringe with/ without needle for single use
• 2. Sterile Hypodermic Safety Syringe (Clip Type) with/ without needle for single use
• 3. Sterile Hypodermic Safety Syringe (Needle Retractable Type) with needle for single use
• 4. Sterile Hypodermic Needle for single use

In safety syringes a safety feature available, which is activated either manually or automatically. In clip type safety syringe, a clip is attached to the barrel and it is activated manually after use of syringe, which helps to prevent needle stick injury. In retractable type safety syringe a needle retract after use of syringe, which helps to prevent needle stick injury. This feature is activated when plunger is pressed to expel the contents, the base of the plunger attached with the needle and pulling back of the plunger will cause the needle to retract in to the barrel of the syringe.

The provided text is a 510(k) summary for hypodermic syringes and needles. It does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving its performance. The document pertains to traditional medical devices (syringes and needles) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and biocompatibility testing, rather than AI/ML related performance metrics.

Therefore, I cannot extract the information required in your request about acceptance criteria and study details for an AI/ML device from this specific document. The request's template (acceptance criteria table, sample size for test/training, number/qualifications of experts, adjudication, MRMC study, standalone performance, ground truth, effect size) is designed for AI/ML device evaluations, which are not present in this 510(k) summary.

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