(29 days)
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
| Acceptance Criteria (from Standards) | Device Performance (Reported) |
|---|---|
| ISO 11608-2:2012 | |
| Needle based injection systems for medical use - Requirements and test methods -- Part 2: Needles | "The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards: ISO 11608-2:2012... The verifications have shown evidence that the Clickfine 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." |
| ISO 9626:1991/Amd.1:2001 | |
| Stainless steel needle tubing for the manufacture of medical devices | "The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards: ...ISO 9626:1991/Amd.1:2001... The verifications have shown evidence that the Clickfine 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." |
| ISO 7864:1993 | |
| Sterile hypodermic needles for single use | "The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards: ...ISO 7864:1993... The verifications have shown evidence that the Clickfine 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." |
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.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).