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The Clickfine AutoProtect Pen Needle for use with pen injector devices for the injection of fluids, including insulin and exenatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

The pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of fluids. Each needle is individually packaged in a sealed protective container with a peel tab.

The pen needle is used by peeling back the peel tab and snapping or screwing the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the skin, the safety shield glides into the housing enabling the needle to penetrate the skin barrier and the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism is activated. The pen-injector delivers the medicinal product through the needle.

After the injection, in order to remove the needle from the skin, the user withdraws the pen injector from the skin. As the pen and needle is withdrawn from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (providing passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.

This document describes a 510(k) premarket notification for the "Clickfine AutoProtect Pen Needle" (K152514). The purpose of this submission is to expand the range of needle lengths to include a 5 mm needle. The document references various ISO standards and internal protocols for performance testing to demonstrate substantial equivalence to the predicate device.

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

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

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

The document does not explicitly state the sample sizes for each specific test or the country of origin of the data. However, it indicates that the testing was conducted as part of "Design Control Activities" by Ypsomed AG, which is a Swiss company. The testing is prospective in nature, as it is conducted to verify the performance of the modified device before it is marketed. The data provenance can be inferred as originating from Ypsomed AG's internal testing facilities, likely in Switzerland, to demonstrate compliance with international standards.

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

This is a medical device, not an AI/imaging device requiring expert adjudication for ground truth of imaging data. The "ground truth" for these tests is established by objective measurements against predefined acceptance criteria from international standards (ISO). Therefore, no human experts were used to establish a "ground truth" in the way it would be for, for example, classifying medical images. The expertise lies in the engineers and technicians performing the tests and interpreting the results against the standard requirements.

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

Not applicable in the context of this device. The testing involves objective measurements and functional assessments against standards, not subjective interpretations requiring 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 a physical medical device (pen needle), not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device. The "performance" described is the device's mechanical and functional compliance with established safety and quality standards, not an algorithm's performance.

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

The ground truth is based on established international ISO standards (e.g., ISO 11608-2, ISO 9626, ISO 7864, ISO 23908) which define specific, measurable requirements for physical and functional characteristics of hypodermic needles and sharps injury protection devices. These standards represent scientific and engineering consensus on acceptable device performance and safety.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

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The Clickfine AutoProtect Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin and exenatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

The Clickfine AutoProtect 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 pen needle is used by peeling back the peel tab and snapping the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be activated. The pen-injector delivers the medicinal product through the needle.

After the injection, in order to remove the needle from the skin, the user moves the pen injector away from the skin. As the pen and needle is moved away from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (provide passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.

The provided document for K131123 states that no performance and safety data were required because the submission was for an administrative change to revise the Indications for Use. Therefore, the document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The submission is specifically to align the Indications for Use of the Clickfine AutoProtect Pen Needle with those of the predicate device, the BD AutoShield Pen Needle (K060007), to allow for Over-The-Counter (OTC) marketing for all compatible injection pens. The document explicitly states: "As this was an administrative change, no performance and safety data were required to be submitted in support of the change."

As a result, I cannot provide the requested information.

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The Clickfine AutoProtect pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen. Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

The Ypsomed Clickfine AutoProtect 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 pen needle is used by peeling back the peel tab and snapping the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be activated. The pen-injector delivers the medicinal product through the needle. After the injection, in order to remove the needle from the skin, the user moves the pen injector away from the skin. As the pen and needle is moved away from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (provide passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect pen needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent iniection, another disposable needle must be used.

The provided text is a 510(k) summary for a medical device (Clickfine AutoProtect Pen Needle) and describes its safety and effectiveness based on compliance with various standards, rather than a study comparing its performance against specific acceptance criteria with quantifiable metrics. Therefore, it is not possible to fully answer your request in the format you provided, as the document does not contain the specific statistical results, sample sizes for test sets, expert qualifications, or adjudication methods typically found in a clinical study report for AI/CAD devices.

However, I can extract the information that is present and indicate where information is missing.

Here's an attempt to structure the available information, noting the missing elements:

Device: Clickfine AutoProtect Pen Needle

Description of Device: The Ypsomed Clickfine AutoProtect Pen Needle is a sterile, non-pyrogenic, single-use needle designed for use with pen-injectors to administer prescribed fluids. Its key feature is an automatic safety shield that covers the needle after withdrawal from the skin to minimize the risk of accidental needle-stick injury. Once locked, the needle cannot be reused, and a red indicator confirms activation of the safety lock.

Intended Use: The Ypsomed Clickfine AutoProtect Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen. Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.

1. Table of Acceptance Criteria and Reported Device Performance

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Material Composition | ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of medical devices (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 9626:1991Amd.1:2001...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Sterility & Single Use | ISO 7864:1993 Sterile hypodermic needles for single use (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 7864:1993...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 10993-1:2009...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Seal Integrity | Seal Integrity of Sterile Barrier (Specific criteria not provided in summary) | "Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices. The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [Seal Integrity of Sterile barrier]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Sharps Injury Protection (Safety Mechanism) | ISO/FDIS 23908 (N156) Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, catheters, introducers for catheters and needles used for blood sampling (Specific metrics not provided in summary, but implies successful activation and locking) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO/FDIS 23908 (N156)...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |
| Simulated Use (Sharps Injury Prevention) | Simulated Use Studies per FDA Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features, dated August 9, 2005 (Specific metrics like activation rate, accidental sticks not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [Simulated Use Studies per FDA Guidance...]"

"The verifications have shown evidence that the Clickfine AutoProtect Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product." |

As this is a 510(k) for a physical medical device and not an AI/CAD system, several of your requested points are not applicable or the information is not provided because such studies are not typically performed for this type of device.

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

• Sample size: Not specified. The document states "Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols." The specific number of devices tested for each standard is not provided.
• Data provenance: Not explicitly stated, but implying tests were conducted in accordance with international standards (ISO) and FDA guidance, likely in a controlled laboratory setting or clinical simulation. It is a prospective assessment of newly produced devices.

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

• Not applicable in the context of device performance testing against engineering standards. "Ground truth" here refers to the specifications and requirements defined by the referenced ISO standards and FDA guidance. Experts would be involved in developing those standards and subsequently in conducting and interpreting the tests, but no specific number or qualifications are mentioned for this particular submission.

4. Adjudication method for the test set:

• Not applicable in the context of device performance testing against engineering standards. Testing against standards is typically objective measurement against predefined technical specifications.

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 device is a physical pen needle with an automatic safety mechanism, not an AI/CAD system that assists human readers in interpreting medical images or data.

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

• Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance refers to the device's inherent functional characteristics, specifically its ability to perform injections and activate its safety mechanism as designed. This was assessed through compliance with the listed standards and simulated use studies.

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

• The "ground truth" for this device's performance is established by the requirements and test methods defined in the cited international standards (ISO) and FDA guidance documents. These standards set the benchmarks for sterility, material properties, mechanical function, biocompatibility, and sharps injury prevention features. Compliance is demonstrated through objective physical and biological testing.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML model, this question is irrelevant.

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