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The intended use of this device is for the removal of 90 degree winged infusion sets, manufactured by Harmac Medical Products and having a 1-1/2" needle or shorter, from implanted ports and the containment of the used needle until placed in an appropriate sharps container. When used in this manner this device is intended to aid in the prevention of needle stick injuries.

The Harmac Medical Huber Needle Safety Device is designed as an accessory to Harmac Huber Needle Infusion Sets to assist in the removal and containment of ninety-degree Huber needles from implanted IV ports. The device consists of a single injection molded plastic component incorporating a stabilizing foot and an internal design to capture the proprietary needle hub of the Harmac Medical Infusion Set as it is slid up a receiving slot in one side. Only one version of the device will be marketed and will accommodate a range of Harmac Huber needles up to 19 gauge, 1-1/2" in length. The Huber Needle Safety Device is used by placing the open slot over the hub of the Harmac Infusion Set needle and using the foot of the device to stabilize the patient's skin via downward pressure with one hand. The other hand is used to grasp the wings of the Huber needle and draw it upward into the Safety Device. As the Huber needle reaches the top of the device the proprietary head locks into place. As the needle is drawn upwards it is also turned slightly to the side to keep the needle from protruding through the receiving slot. This method of operation requires two hands but eliminates the rebound reflex by locking the needle hub and keeping the other hand behind the device at all times. The Huber Needle Safety Device is provided as a sterile accessory packaged only with Harmac Infusion Sets. It is provided as a disposable, single use device.

The Harmac Huber Needle Safety Device's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Bench Testing: The document does not specify an exact sample size (number of devices or tests performed) for the Instron tester measurements, but it refers to "bench studies," implying multiple tests were conducted to determine average forces and standard deviations.
• Simulated Clinical Studies: Over 480 safety devices were tested.
• Data Provenance: The studies were conducted retrospectively as part of the design control phase at Harmac Medical Products, Inc. The location of the test (Harmac facilities) does not specify country of origin for data, but implies the studies were conducted internally for product development.

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

• Number of Experts: The simulated clinical studies involved "health care professionals familiar with the intended use of the device as well as the predicate device." The exact number of individual health care professionals is not specified, only that "health care professionals" participated.
• Qualifications of Experts: They were "health care professionals familiar with the intended use of the device as well as the predicate device." No further specific qualifications (e.g., years of experience, specific medical roles) are provided. They received "in-service training."

4. Adjudication Method for the Test Set:

• The document does not explicitly state an adjudication method (such as 2+1 or 3+1) for the simulated clinical studies. The health care professionals filled out a "detailed evaluation form during the study," implying direct observation and reporting of events (needle sticks, problems with safety feature) by these professionals, rather than a separate adjudication process of their findings. The outcome of 0 needle stick injuries and 0 significant problems suggests a clear-cut result rather than a need for complex adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a mechanical safety accessory, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the typical sense of medical imaging or clinical decision support. The study focused on the device's ability to prevent needle stick injuries during its intended use.

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

• N/A. This device is a physical safety accessory, not an algorithm. Its function inherently involves human interaction (removing a needle). The bench testing could be considered a "standalone" mechanical performance test in a highly controlled environment, but the simulated clinical studies involved human users.

7. The Type of Ground Truth Used:

• Bench Testing: Engineering measurements (force to engage/disengage from Instron tester).
• Simulated Clinical Studies: Direct observation and self-reporting by health care professionals regarding the occurrence of needle stick injuries and functional problems with the safety device during simulated use on port trainers. This is essentially empirical, real-world (simulated) outcome data on injury prevention and device function.

8. The Sample Size for the Training Set:

• None applicable in the context of an AI training set. This is a physical medical device, not an AI model. Therefore, there is no "training set" in the machine learning sense. The "design control phase" involves iterative design, prototyping, and testing, which refine the product but are not "training" an algorithm.

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

• N/A. As there is no AI training set, there is no ground truth established for such a set.

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