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The SureFlow™ Safety Infusion Device is a device intended to allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump.

By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks.

The SureFlow™ Safety Infusion Device is a needleless, sterile, non-pyrogenic single use intravenous fluid administration set which provides multiple access ports and regulates the directional flow of fluids for simultaneous intravenous therapy. It has 3 ports with swabable luers, integrated check valves, and pre-attached needleless injection ports all connecting to a drip chamber. A 4th port with a swabable luer and pre-attached needleless injection port allows for flushing of the chambers.

It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by eliminating the use of needles in the delivery of medications via IV infusion, thus eliminating the opportunity for accidental needlesticks.

In addition, the SureFlow™ aids in reducing nosocomial infections by not requiring a break in the fluid path once the needleless syringes are connected to the SureFlow™. The valves are swabbed prior to connection which provides an uninterrupted, sterile fluid path versus the current practice of repetitive access to the IV port with needles which are exposed to airborne contamination.

It is supplied sterile for single use only

The provided text is a 510(k) summary for the SureFlow™ Safety Infusion Device, which is an intravascular administration set. This document is a premarket notification for a medical device and describes its intended use, technological characteristics, and comparison to a predicate device.

However, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria, specifically:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How training set ground truth was established.

The document states:

• "The SureFlow™ Safety Infusion Device has been shown to be substantially equivalent to the predicate device by non-clinical performance data. The testing involved performance testing, and biocompatibility testing."
• "A summary of the technological characteristics of this device compared to the predicate device can be seen in the Comparison Table in the Specifications Section." (This section is not included in the provided text.)

Therefore, based on the provided text alone, it is not possible to answer the specific questions about the acceptance criteria and the study that proves the device meets them. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical data, rather than detailing specific performance metrics against defined acceptance criteria in the manner requested (e.g., for an AI/ML device).

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