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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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The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

All of the subject device pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The subject device pen needles are used by peeling back the peel tab. The hub of the currently marketed Clickfine Pen Needle is snapping or screwing onto the threaded end of the pen injector. The modified Penfine Classic Pen Needle is attached to pen injectors with only a "screwing" motion. For all needles the back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the fluid is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then unscrewed for the pen injector, discarded and replaced with a new needle before the next injection.

This FDA 510(k) summary describes the "Clickfine Pen Needle" and "Penfine Classic Pen Needle" by Ypsomed AG. The document details the device's intended use and demonstrates its substantial equivalence to a predicate device.

Here's an analysis of the provided text based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several tests and associated clauses from international standards (ISO 11608-2, ISO 9626/A1, ISO 7864) which serve as the acceptance criteria. The reported device performance is that "The verifications have shown evidence that the subject device pen needles meet the acceptance criteria of these standards." and "Based on the results it can be concluded that the device performance is acceptable for the product." While the specific quantitative results for all tests are not provided in this summary, the criteria themselves are detailed.

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "appropriate verification and/or validation activities" were performed.

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

This type of information is not relevant or applicable for the device described (hypodermic single lumen needles). The performance is assessed against engineering and material standards, not against expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective measurements against established engineering and material standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for a medical device like a pen needle, which is evaluated based on its physical and functional properties against technical standards. MRMC studies are typically used for diagnostic devices that involve human interpretation of images or other data.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The studies performed were "standalone" in the sense that they evaluated the device itself against established engineering and material standards. There is no "algorithm" or "human-in-the-loop" aspect for a hypodermic needle's performance. The tests described are laboratory-based assessments of the physical and mechanical properties of the needles.

7. The Type of Ground Truth Used

The ground truth for this device is based on established international engineering and material standards (ISO 11608-2, ISO 9626/A1, ISO 7864). These standards define objective, measurable criteria for the performance, dimensions, and material properties of hypodermic needles.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML-based system that requires "training data." Its performance is evaluated through physical tests and measurements.

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

Not applicable, as there is no "training set" for this type of device.

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