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These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected to the pen. The needle cap cover is intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

This document describes a 510(k) submission for the Comfort EZ Pen Needle, a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of AI-based diagnostic performance. Therefore, many of the requested elements for describing a study proving a device meets acceptance criteria related to AI or diagnostic accuracy are not applicable.

Based on the provided text, the device in question is a Comfort EZ Pen Needle, which is a medical device for drug delivery (insulin) and not a diagnostic AI system. Therefore, the typical acceptance criteria and study designs relevant to AI/diagnostic performance (such as sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this document.

The "study" described in this 510(k) summary is a set of bench tests and demonstrations of substantial equivalence to existing predicate devices, as is standard for many medical devices, particularly those for which equivalence can be shown based on design and performance characteristics rather than complex diagnostic interpretation.

Here's an attempt to address the points based on the provided text, noting where the requested information is not relevant to a pen needle:

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

Since this is a non-AI, non-diagnostic device, the acceptance criteria are based on physical and functional properties, and the performance is reported against these.

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

• Sample Size: Not explicitly stated for each bench test. Bench tests typically involve a specific number of units to ensure statistical significance for the particular test being conducted (e.g., a certain number of needles for mechanical force testing, or samples for sterility testing). The document does not provide these specifics.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is standard for internal product development and testing of a device rather than a clinical study with patient data. The tests would be performed in a controlled laboratory environment.

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

• Not Applicable. This device does not involve diagnostic interpretation or "ground truth" established by human experts in the way an AI diagnostic device would. Bench tests follow established laboratory protocols and standards (e.g., ISO standards for pen compatibility, AAMI standards for sterility). Compliance with these standards serves as the "ground truth" for device performance.

4. Adjudication method for the test set:

• Not Applicable. There's no human interpretation or subjective assessment that would require 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. This is not an AI or diagnostic device, so an MRMC study is not relevant.

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

• Not Applicable. This is not an algorithm or AI device. The "performance" described is the physical and functional performance of the pen needle itself.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by international standards (e.g., ISO "Type A" for pen compatibility), manufacturing specifications, and industry best practices for medical device safety and efficacy (e.g., biocompatibility standards, sterility assurance levels). It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device's ground truth would be.

8. The sample size for the training set:

• Not Applicable. This device does not involve machine learning or a "training set."

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

• Not Applicable. There is no training set for this type of device.

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