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The Power Injectable Infusion Set with Huber Needle is indicated for:

• Use with implanted infusion ports for continuous or intermittent infusion therapy. .
• Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
• Use with ports that are indicated for power injection of contrast media into the central . venous system. For power injection of contrast media, the maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
• Power injection of contrast media up to 325 PSI. .

The Power Injectable Infusion Set with male luer lock is indicated for:

• Use with central venous catheters for continuous or intermittent infusion therapy. .
• Infusion or withdrawal of IV fluids, blood, blood products, or drugs. ●
• Use with central venous catheters that are indicated for power injection of contrast media . into the central venous system.
• . Power injection of contrast media up to 325 PSI.

The Power Injectable Infusion Set, consists of a female luer lock, non-DEHP PVC tubing, on/off clamp, and either a male luer lock for connection to female hub central venous catheters or Huber needle for insertion into implanted port catheters.

The Power Injectable Infusion Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.

The MPS Acacia Power Injectable Infusion Set is a Class II device (product code FPA) intended for general infusion therapy and power injection of contrast media.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria with numerical targets or thresholds. Instead, it refers to general "necessary verification and validation testing" to assure "substantial equivalence" to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generically states that "All necessary verification and validation testing has been performed."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of device submission. The device is a medical accessory (infusion set) and its performance evaluation does not typically involve expert review or establishment of "ground truth" in the way a diagnostic AI algorithm would. Its performance is assessed through engineering and biocompatibility testing.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often with AI assistance. The Power Injectable Infusion Set is a physical medical device, not a diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

No, a standalone study (in the context of an algorithm) was not done. This device is a physical product and does not involve an algorithm.

7. The Type of Ground Truth Used:

This information is not applicable in the traditional sense of a diagnostic device. The "ground truth" for this device's performance would be established through a combination of engineering specifications, material science standards, and performance testing against predetermined physical and functional parameters. For example, pressure ratings, flow rates, and material integrity are tested in a controlled environment. The document implies compliance with these via "all necessary verification and validation testing."

8. The Sample Size for the Training Set:

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for this device.

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