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

The Clickfine 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 needles are used by peeling back the peel tab and snapping or screwing the hub onto the threaded end of the pen injector. 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 insulin 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 removed, safely discarded and replaced with a new needle.

This submission (K131125) is an administrative change to revise the Indications for Use for the Clickfine Pen Needle to align with predicate devices, allowing for Over-the-Counter (OTC) marketing for all compatible injection pens. As such, no new performance data was required or submitted to demonstrate safety and effectiveness. The FDA concluded substantial equivalence based on the administrative nature of the change and the existing clearance of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this was an administrative submission and no new performance and safety data were required or submitted, there are no specific acceptance criteria or reported device performance metrics in this document. The device did not undergo a new study to establish performance against new criteria.

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

Not applicable. No new performance studies were conducted.

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

Not applicable. No new performance studies were conducted.

4. Adjudication Method for the Test Set:

Not applicable. No new performance studies were conducted.

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

No. This was an administrative change, not a comparative effectiveness study.

6. If a Standalone Performance Study Was Done:

No. This submission did not involve a standalone performance study. The substantial equivalence was based on existing predicate devices.

7. The Type of Ground Truth Used:

Not applicable. No new performance studies were conducted. The "ground truth" for this submission was the existing clearances and intended uses of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. No new studies involving training sets were conducted.

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

Not applicable. No new studies involving training sets were conducted.

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The Clickfine pen needle is intended for the hypodermic injection of insulin into the body when attached to an injection pen.

The Ypsomed Clickfine 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 needles are used by peeling back the peel tab and suapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the peninjector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin 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 removed, safely discarded and replaced with a new needle.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Clickfine Pen Needle, formatted as requested:

Acceptance Criteria and Device Performance for Clickfine Pen Needle

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 explicitly state the specific sample sizes used for testing against the ISO standards. It generally refers to "relevant assessments" and "verifications." The data provenance is internal to Ypsomed AG, implying it's company-generated data, but the country of origin of the actual tests or whether it was retrospective or prospective is not specified.

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

This information is not provided in the document. The "ground truth" here would be the objective measurements and adherence to the technical specifications outlined in the ISO standards, not expert human interpretation.

4. Adjudication method for the test set

This is not applicable as the "adjudication" is based on objective measurements against the quantitative and qualitative requirements of the listed ISO standards, not on human interpretation or consensus.

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

A multi-reader multi-case (MRMC) study is not relevant or mentioned in this document. This device is a physical medical device (hypodermic pen needle), not an AI-powered diagnostic or assistive technology.

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

This is not applicable. The device is a physical pen needle, not an algorithm. Performance is assessed through physical and material testing.

7. The type of ground truth used

The "ground truth" used for this device is the objective technical specifications and performance requirements outlined in the referenced international standards (ISO 11608-2:2012, ISO 9626:1991/Amd.1:2001, ISO 7864:1993). This would involve laboratory testing and measurements to ensure the needle meets criteria for things like sterility, dimensions, material strength, penetration force, and compatibility.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this traditional medical device. No machine learning or AI algorithm development is described.

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

This is not applicable, as there is no training set for this device.

Ask a specific question about this device

The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.

The Ypsomed Clickfine 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 needles are used by peeling back the peel tab and snapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the peninjector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug 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 removed, safely discarded and replaced with a new needle.

The provided document describes the "Clickfine Pen Needle" and its substantial equivalence to a predicate device (K102108). The information focuses on regulatory compliance based on established international and internal standards rather than a typical clinical study with acceptance criteria often seen for AI/ML devices or diagnostic tools.

However, based on the provided text, I can extract the relevant information regarding performance and safety criteria, which serve as acceptance criteria for this device, and the "study" (referencing the assessments performed).

Here's the breakdown of the requested information:

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 specify a "test set" sample size in the context of a clinical trial or algorithm evaluation. The performance and safety data are derived from "relevant assessments specified in the following international and internal standards and protocols." These standards (ISO 11608-2, ISO 9626, ISO 7864) typically involve laboratory testing of device components and finished products according to defined sampling plans, but the specific sample sizes used in Ypsomed's internal testing are not disclosed in this summary.

Data provenance: Given that Ypsomed AG is located in Switzerland, it can be inferred that the internal testing and data generation likely originated from Switzerland. The studies are prospective in the sense that they are validations and verifications performed on manufactured devices to ensure they meet specified standards.

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)

This type of information is not relevant or provided in the context of this device and its regulatory submission. The "ground truth" for a pen needle is its compliance with engineering and material standards, which is assessed through defined laboratory tests, not expert consensus on interpretations.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies or diagnostic evaluations, where human interpretation is involved. For a physical medical device like a pen needle, performance is assessed through objective, standardized physical and material tests.

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-assisted diagnostic or interpretation device that would involve human readers.

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

Not applicable. This is not an algorithm-based device. Its performance is inherent in its physical and material properties.

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

The "ground truth" for the Clickfine Pen Needle's performance and safety is its adherence to the technical specifications defined in the international standards:

• ISO 11608-2:2012: Focuses on the performance and safety of the needle unit in injection systems.
• ISO 9626:1991/Amd.1:2001: Specifies requirements for stainless steel tubing used in medical devices, including dimensional accuracy and material properties.
• ISO 7864:1993: Covers requirements for sterile hypodermic needles for single use, including sterility, sharpness, and cannula integrity.

Compliance with these standards, verified through objective testing methodologies, serves as the "ground truth."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a 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, no ground truth needed to be established for it.

Ask a specific question about this device

The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.

The Yosomed Clickfine 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 needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the pen injector. 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 insulin 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 removed, safely discarded and replaced with a new needle.

Acceptance Criteria and Device Performance Study for Clickfine Pen Needle

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes used for each of the tests. The studies involved testing the Ypsomed Clickfine Pen Needles against various international and internal standards and protocols.

The data provenance is from Ypsomed AG, a company based in Switzerland, indicating that the testing was conducted by or under the supervision of the manufacturer. The studies are assumed to be prospective, as they were conducted to demonstrate compliance and equivalence for the modified device.

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

This information is not provided in the document. The studies were based on compliance with established international and internal standards, which typically have predefined objective criteria for evaluation rather than relying on expert consensus for ground truth on a case-by-case basis.

4. Adjudication Method for the Test Set

This information is not explicitly stated. Given that the acceptance criteria are based on compliance with international and internal standards, the adjudication would likely involve direct measurement and comparison against predefined thresholds or specifications outlined in those standards, rather than an expert adjudication method like 2+1 or 3+1.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a physical medical device (pen needle), and its performance evaluation focuses on physical, mechanical, and biological properties, not on interpretation by human readers.

6. If a Standalone Performance Study Was Done

Yes, standalone performance studies were done. The "Performance and Safety Data" section explicitly states that Ypsomed "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." This implies that the device's performance was evaluated independently against established criteria in these standards.

7. The Type of Ground Truth Used

The ground truth used for these studies was based on the requirements and test methods specified in the cited international standards (ISO 11608-2, ISO 9626, ISO 7864, ISO 10993-1) and internal protocols. These standards define objective, measurable criteria for the performance, safety, and biological compatibility of pen needles. For example, "puncture resistance" and "seal integrity" would have quantifiable thresholds or specifications within these standards or internal protocols that the device's measurements needed to meet.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The Clickfine Pen Needle is a physical medical device, not an algorithm or AI model that requires a training set.

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

This information is not applicable. The device is a physical medical device and does not utilize a training set in the way AI or machine learning models do.

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The Clickfine pen needle is intended for the hypodermic injection of insulin into the body when attached to a peninjector.

The Ypsomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for insulin administration. Each needle is individually packaged in a sealed protective container with peel tab. The pen needles are used by peeling back the peel tab and snapping the while per table threaded end of the pen injector. 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 insulin 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 insulin through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

The provided text describes the 510(k) summary for the Ypsomed Clickfine Pen Needle. This document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving new acceptance criteria for a novel AI-powered medical device.

Therefore, many of the requested points regarding AI, ground truth, experts, and specific clinical study designs are not applicable or cannot be extracted from this text. The information below is based only on the provided document.

Here's the information that can be extracted from the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states "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."
• However, specific sample sizes for these tests are not provided in the document.
• The data provenance (e.g., country of origin, retrospective/prospective) is not specified in the document.

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

• This information is not applicable as the document describes testing against international standards for a physical medical device, not an AI or imaging device requiring expert ground truth in the traditional sense. The "ground truth" here is the pass/fail criteria of the specified standards.

4. Adjudication method for the test set:

• This is not applicable for the type of testing described (compliance with international standards for a physical device). The tests would likely have objective pass/fail criteria based on measurements.

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:

• This is not applicable. The device is a pen needle, not an AI-powered diagnostic tool. No AI component is mentioned.

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

• This is not applicable. The device is a pen needle, not an algorithm.

7. The type of ground truth used:

• For the physical tests described, the "ground truth" is defined by the acceptance criteria and test methods specified in the cited international standards (e.g., ISO 11608-2, ISO 9626, ISO 7864, ISO 10993-1), as well as internal standards and protocols. Implicitly, functional equivalence to the predicate device (Disetronic Penfine Insulin Injection Pen Needles, K013782) also serves as a comparative benchmark.

8. The sample size for the training set:

• This is not applicable as the device is a physical pen needle, not an AI or machine learning model. There is no concept of a "training set" in this context.

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

• This is not applicable for the reasons stated in point 8.

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