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0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling. total parenteral nutrition, or hemodialysis.

0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:

• 2.5 mL in 3 mL Syringe
• 3 mL in 10 mL Syringe
• 5 mL in 10 mL Syringe
• 10 mL in 10 mL Syringe
  The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.

The provided text does not describe an acceptance criteria or a study proving that a device meets the acceptance criteria for a medical device that utilizes artificial intelligence (AI). The document is a 510(k) premarket notification for a 0.9% Sodium Chloride Injection, USP (a saline vascular access flush). This is a physical, sterile medical product, not an AI-driven device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be extracted from this document.

The document discusses non-clinical testing performed for the saline solution and prefilled syringes, which includes:

• Raw material qualification
• Stability Studies
• Sterilization validation
• Extractables/Leachables

These tests are standard for a sterile drug product/device combination and are not related to AI performance. Biocompatibility testing was deemed not required because the products were considered the same as predicate devices, except for the source of the sodium chloride raw material.

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