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The Stat Medical Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin. This is the same intended use as previously cleared for the Stat Medical Pen Needle, K042917.

The Stat Medical Pen needle consists of 4 parts, the needle hub, the needle protector and the outer cover. The cannula is manufactured from 304 stainless steel. The cannula is produced into three sizes for the device (the 29g 12.7 mm (1/2 in), 31g 5mm (3/16 in) and the 31g 8mm (5/16 in). The cannula length and inner diameter are a constant for these three sizes, which differ in the outer diameter of the cannula.

The hub is molded from medical grade polypropylene, and medical grade silicon. The needle is glued into place in the hub and is coated with a medical grade silicon/lube. The silicone oil/lube is non-toxic, pyrogen free, and free from contamination. After assembly, the hub and needle assembly are tested, packaged, and sterilized.

The Stat Pen Needle is provided sterile via EO sterilization and is for Single Use only.

The modification to the original filing is the correction of where the silicon coating is applied to the device, and a change in the product labeling to include the identification of the silicon coating. Product labeling may be found in section 9 of this submission.

This document is a 510(k) summary for a medical device (Stat Medical Pen Needle), not a study analyzing device performance against acceptance criteria in the context of AI/ML or comparative effectiveness. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or provide performance data from a study for the device. It focuses on demonstrating substantial equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a 510(k) submission document for a physical medical device, not an AI/ML-driven study. There is no "test set" in the context of evaluating algorithm performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no "ground truth" to establish in this context as it's not an AI/ML study. The determination of device characteristics and substantial equivalence is based on engineering specifications and comparison to a predicate device, not expert consensus on data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no test set for 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:

Not applicable. This is not an MRMC comparative effectiveness study involving human readers and AI.

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

Not applicable. This is not a study of an algorithm; it's a submission for a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. There is no ground truth in the context of an AI/ML study mentioned here. The "truth" for this device revolves around its physical properties, manufacturing processes, and adherence to safety and performance standards equivalent to a predicate device.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is not an AI/ML study.

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

Not applicable. There is no training set and therefore no ground truth establishment for a training set.

Summary of Device and 510(k) Filing Information (from the document):

• Name of Device: Stat Medical Pen Needle / Super-Fine Pen Needle
• Common Name: Sterile disposable hypodermic needle
• Intended Use: For use with a pen injector device for the subcutaneous injection of insulin.
• Description: Consists of a needle hub, needle protector, outer cover, and a cannula made of 304 stainless steel. Available in 29g 12.7mm, 31g 5mm, and 31g 8mm. The hub is molded from medical grade polypropylene and silicon. The needle is silicon coated, glued, tested, packaged, and sterilized by EO.
• Modification: Correction of where the silicon coating is applied and a change in product labeling to include identification of the silicon coating.
• Substantial Equivalence Claim: Based on same indication for use, same operating principle, incorporation of same materials, same sterilization and packaging, and same basic design as a predicate device (K042917).
• Regulatory Status: Cleared via 510(k) (K092016) on October 2, 2009. Classified as Class II, product code FMI (Hypodermic single lumen needle).

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