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This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.

The GRIPPER® Micro needle is comprised of the inserter and the infusion site with extension tubing and a standard luer fitting; there are versions either with or without needless access connector y-site. The inserter incorporates a sharp trocar needle and retractor arm. The infusion site incorporates a small septum and an attached blunt cannula. When fully assembled, the inserter and infusion site are combined with the trocar needle inserted through the septum and blunt cannula. After insertion of the cannula and trocar into the implanted port, the inserter retractor arm is activated removing the trocar needle from the cannula and infusion site septum leaving the blunt cannula in the implanted port. The trocar needle tip is captured in the inserter to prevent needle stick injury, and the inserter is discarded. Upon removal of the infusion site from the implanted port, the blunt cannula is designed to further prevent needle stick injury that may result from rebounding action during infusion site extraction.

The provided text describes the GRIPPER® Micro 1.25 Inch Needle, which is an intravascular administration set designed to administer or withdraw fluids from implanted ports while preventing accidental needlestick injuries.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 500 activations.
• Data Provenance: The study was a "Simulated Use Study" conducted in accordance with FDA Guidance. This implies a prospective study involving human participants in a controlled, simulated environment, rather than retrospective real-world data. The country of origin for the data is not explicitly stated, but given the FDA guidance and the submitter's address in St. Paul, MN, it is highly probable the study was conducted in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The text does not specify a number of "experts" used to establish ground truth in the traditional sense of diagnostic assessment.
• Instead, the "ground truth" for the simulated use study was the successful capture of the trocar tip in the capture zone. This is an objective, binary outcome.
• The participants in the study were "Health care professionals... experienced in accessing and de-accessing implantable portals." Their role was to perform the simulated activities, not to adjudicate or establish a diagnostic ground truth.

4. Adjudication method for the test set

• There was no explicit adjudication method described in the text for the simulated use study.
• The outcome (successful capture of the trocar tip) appears to be an objective, directly observable event rather than one requiring expert interpretation or consensus. It likely involved a pass/fail assessment recorded for each activation.

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, an MRMC comparative effectiveness study was not done. This device is a medical needle, not a diagnostic imaging AI system. The study focused on the physical performance and safety features of the device during simulated use, not on human interpretation or AI assistance.

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

• No, a standalone algorithm performance study was not done. This device is a physical medical device. The "simulated use study" involved human healthcare professionals interacting with the device to evaluate its performance and safety features.

7. The type of ground truth used

• For the simulated use study, the ground truth was objective device performance: successful capture of the trocar tip in the capture zone. This is a direct outcome measure of the safety feature's functionality.

8. The sample size for the training set

• The concept of a "training set" is not applicable to this device or its evaluation. This is a physical medical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

• Not applicable (as explained in point 8).

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This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.

The GRIPPER® Micro needle is compromised of the inserter and the infusion site with extension tubing and a standard luer fitting; there are versions either with or without needless access connector y-site. The inserter incorporates a sharp trocar needle and retractor arm. The infusion site incorporates a small septum and an attached blunt cannula. Fully assembled, the inserter and infusion site are combined with the trocar needle inserted through the septum and cannula. After insertion of the cannula and trocar into the implanted port, the inserter retractor arm is activated removing the trocar needle from the cannula and infusion site septum leaving the blunt cannula in the implanted port. The trocar needle tip is captured in the inserter to prevent needle stick injury, and the inserter is discarded. Upon removal of the infusion site from the implanted port, the blunt cannula is designed to further prevent needle stick injury that may result from rebounding action during infusion site extraction.

The provided document is a 510(k) Premarket Notification for a medical device (GRIPPER® Micro Needle), not an AI/ML device. Therefore, none of the requested information regarding acceptance criteria, study details, ground truth, or expert involvement for an AI/ML product is present in the document.

The document states:

• "The GRIPPER® Micro needle met all established acceptance criteria for performance testing and design verification testing." (Section IX.A)
• "Based upon the information provided; the GRIPPER® Micro needle meets all acceptance criteria for performance testing and design verification testing. Therefore, this product is considered acceptable for human use." (Section IX.C)
• "Clinical studies for the GRIPPER® Micro needle was deemed not necessary due to its similarity in materials, design and function to current Smiths Medical MD, Inc. devices." (Section IX.B)

This indicates that the acceptance criteria are related to "performance testing and design verification testing" for the physical device, and these criteria were met. However, the specific details of these criteria (e.g., fluid flow rate, needle strength, resistance to bending, etc.) and the studies proving they were met are not included in this summary.

Therefore, I cannot populate the requested table and answer the study-specific questions as they pertain to AI/ML device evaluations. The document focuses on the regulatory submission for a physical medical device based on substantial equivalence to a predicate device.

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