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The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.

The PIVO™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes compatible with 20 and 22 gage PIV's, respectively.

The provided document is a 510(k) premarket notification for a medical device called PIVO™, a blood specimen collection device. It details the device's characteristics, indications for use, and a comparison to its predicate device, TIVA™.

However, the document does not contain information related to a study proving the device meets acceptance criteria for an AI-powered medical device, or any acceptance criteria related to AI/algorithm performance. The acceptance criteria mentioned are for a physical medical device, PIVO™, comparing its performance characteristics to a predicate device (TIVA™) after material and component changes.

Therefore, I cannot extract the information required by your prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm.

The document discusses:

• Device Performance Testing:
  • Clamp functional testing
  • Leak testing
  • Dimensional testing
  • Joint strength testing
  • Performance testing
  • Flow rate testing
  • Biocompatibility testing (per ISO 10993-1, -4, -5, -10, -11)
• Summary of Substantial Equivalence: It states that the changes made to PIVO™ (formerly TIVA™) do not raise new questions regarding safety and efficacy, and that PIVO™ is equivalent to the predicate device based on identical indications for use, principles of operation, fundamental scientific technology, and performance specifications. It explicitly states: "The changes made were tested using the same acceptance criteria as the predicate device and provide objective evidence that there are no new risks and the device is substantially equivalent."

Based on the provided text, the device is a physical blood collection device, not an AI or algorithm-driven device. Thus, your request for an AI acceptance criteria table or details about an AI study (sample size, experts, adjudication, MRMC, standalone, ground truth, training set) cannot be fulfilled from this document.

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