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The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.

The Navi™ Needle-free Blood Collection Device is a sterile packaged single use product designed to be attached to an already placed peripheral intravascular catheter (PIVC) system. The device is comprised of an inner flow tube with an atraumatic tip attached to a plunger that is advanced and retracted with the use of a slider. The slider extends through the proximal end of the housing and is connected to the plunger. A male cannula is positioned at the distal end of the housing with Luer clips configured to connect to a PIVC system. The inner flow tube is intended to be advanced distally through the PIVC into a patient blood vessel establishing fluid communication between the blood vessel and the collection assembly. The inner flow tube is designed to extend beyond the distal end of the PIVC. A lateral flexible tube with a female Luer connected to the housing provides a connection point for an evacuated tube holder or syringe to obtain a blood sample. Once complete, the inner flow tube is fully retracted back into the housing, and the device is removed from the PIVC system. The device is available in three sizes (20 GA, 22 GA and 24 GA) that are compatible with the corresponding PIVC.

I am sorry, but the provided FDA 510(k) Clearance Letter for the Navi™ Needle-free Blood Collection Device (K244047) does not contain any information regarding acceptance criteria or the study data that proves the device meets specific performance criteria related to the device's efficacy in blood collection (e.g., blood volume, sample quality, success rate, etc.).

The document primarily focuses on:

• Regulatory classification and equivalence: Comparing the Navi™ device to a predicate device (PIVO™ Pro Needle-free Blood Collection Device, K230865) based on indications for use, intended use, and technological characteristics.
• Safety and basic performance testing: Listing applicable standards and types of tests performed (e.g., pressure leak, vacuum leak, kink resistance, biocompatibility, sterilization, packaging integrity) to demonstrate that the differences from the predicate device do not raise new questions of safety or effectiveness.
• Design and material comparisons: Highlighting similarities and differences in components, dimensions, and materials between the subject and predicate devices.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or to provide details on:

• Sample sizes used for a test set proving efficacy/performance, or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Whether MRMC or standalone (algorithm-only) studies were done, or their effect sizes.
• The type of ground truth used for performance validation.
• Sample size for the training set or how its ground truth was established, as this device is a physical medical device, not an AI/ML-based diagnostic or imaging device that typically has "training sets" and "test sets" in the context of data-driven performance validation.

The document states that "The Navi™ Needle-free Blood Collection Device was tested to demonstrate all product requirements and user needs were met." and "The test data obtained demonstrate that the Navi™ Needle-free Blood Collection Device meets requirements and user needs, and the device is substantially equivalent to the predicate device cleared under K230865." However, it does not explicitly report the quantitative results of these tests against specific numerical acceptance criteria for a "device performance" in the way you've framed the request (e.g., a specific success rate for difficult IV access, or a quantifiable improvement in blood collection efficiency). The tests mentioned (e.g., pressure leak, flow rate, hemolysis) are more fundamental engineering and safety performance tests rather than a clinical efficacy study with acceptance criteria often seen for diagnostic devices.

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