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The Clickfine and Penfine Classic Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

The subject devices are sterile, non-pyrogenic, single use pen needles designed to be used with commercially available pen-injectors. The back end of the needle punctures the rubber injection port of the drug reservoir in the pen. When the injection is needed, the needle is inserted into the chosen site and the pen-injector delivers the fluid through the needle. The materials of construction, (siliconized stainless-steel needle encased in a polypropylene hub with a polypropylene protective cap) as well as the sterile packaging (a polypropylene outer protective container and the peel tab) which provides the sterile barrier and the manufacturing (which includes radiation sterilization) are unchanged from the currently marketed devices. They subject devices will be marketed in the same sizes as the predicate devices - 32 and 31 gauges and 4, 4.5, 5, 6, 8, 10, and 12 mm lengths.

This FDA 510(k) summary focuses on the substantial equivalence of a medical device (pen needle) to a predicate device, rather than the performance of an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the tests. It states "All samples tested" for both breakage and stiffness, implying that a sufficient number was tested to meet the requirements of the specified ISO standards, but the exact number isn't provided. Data provenance is not applicable here as it's a physical device performance test, not a data-driven model.

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

Not applicable. Ground truth for physical device performance is established by standardized measurement methods defined by international standards (ISO). No human expert consensus for "ground truth" in this context is mentioned.

4. Adjudication method for the test set

Not applicable. The tests are pass/fail based on objective measurements against ISO standards. No adjudication method is described.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The ground truth for the device's performance (breakage and stiffness) is defined by the objective measurement criteria and methodologies outlined in the referenced ISO standards (ISO 9626:2016).

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device; there is no "training set" or corresponding ground truth establishment process.

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