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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.

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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.

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The Subcutaneous Infusion Sets with Indwelling Catheters are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.

The general description, operation, construction and use of the Maersk Medical Pureline™ Subcutaneous Infusion Sets With Indwelling Catheters has not changed as a result of the modifications. They remain sterile, non-pyrogenic, single use subcutaneous infusion sets designed to be used with commercially available infusion devices. There are two basic components provided for each device. The first is a stand-alone subcutaneous indwelling catheter. This catheter is provided as an integral assembly with a Teflon cannula, adhesive backed fixation tape, an iniection port and the female portion of a proprietary plastic "click-lock" connector. The catheter assembly comes with a stainless steel insertion cannula. The insertion cannula is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion cannula is come to the user inserted through the injection port and the inner lumen of the Teflon catheter with the needle end protruding past the tip of the catheter. The male connector is locked to the female connector on the indwelling catheter. A needle protector is assembled over the Teflon catheter and the insertion cannula. A separate male portion of the proprietary connector without the insertion cannula is provided in the package. This component is used to attach to the female connector of the catheter after the indwelling Teflon cannula has been inserted and the steel insertion cannula has been withdrawn. The connector protects the indwelling catheter when the infusion set is not attached. The second component of the Maersk Medical Subcutaneous infusion Set with Indwelling Catheter is the infusion set. The infusion set is comprised of a co-extruded tube with a female luer lock connector at the pump end and a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. In order to maintain the sterility of the infusion path, a male luer cap covers the female luer lock connector and the male "click-lock" connector comes attached to a mating female connector. The sets come packaged in blister packs sealed with paper lid stock.

The provided text is a 510(k) summary for the "Maersk Medical Pureline™ Subcutaneous Infusion Set." It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding a device performance study, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, with clear indications where information is not available:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample size: Not specified.
   • Data provenance: Not specified. The study is described as "biocompatibility testing and component security testing," but no details on data origin or study design (retrospective/prospective) are provided.

2. 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/Not specified. The document refers to "testing" (biocompatibility and component security) rather than a study requiring expert-established ground truth in a clinical assessment sense.

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

   • Not applicable/Not specified. There is no mention of adjudication, as the tests are for biocompatibility and component security, not a diagnostic or clinical assessment requiring human expert consensus.

4. 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 a medical device (infusion set) and not an AI/imaging device. Therefore, an MRMC study is not relevant and was not performed.

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

   • No. This is a medical device (infusion set) and not an AI/algorithm-based device. Therefore, standalone algorithm performance is not relevant and was not assessed.

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

   • The "ground truth" equivalent here would be the established safety and performance standards for biocompatibility and component security for such devices. The document states "The results of the biocompatibility testing and component security testing showed the device is substantially equivalent to the unmodified device," implying comparison to established benchmarks or the predicate device's performance. Specific types of ground truth like pathology or outcomes data are not mentioned in this context.

7. The sample size for the training set:

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

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

   • Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.

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