Search Results

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

Fine Ject insulin pen needle consists of a Sterile Cap, needle hub, which can be fixed with needle and blister paper. The sterile cap has function to sustain sterilization of 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 with pen. The needle cap covers intended to provide physical protection to the needle tube.

Fine Ject insulin pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in variougauge sizes (29G, 30 G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). Fine Ject insulin pen needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.

The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge.

This document describes the premarket notification (510(k)) for the Fine Ject Insulin Pen Needle. It details the device's characteristics, comparison to predicate devices, and non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the provided information, focusing on the requested categories. It's important to note that this 510(k) summary is for a medical device (insulin pen needle), not an AI/ML powered device, so many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable. I will address each point as best as the provided text allows.

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 the exact sample sizes used for each non-clinical performance test (e.g., for ISO standards compliance, biocompatibility, sterilization, shelf-life). These are typically determined by the testing protocols for each standard.

The data provenance is from non-clinical testing conducted by Twobiens Co., Ltd. in Korea. The document doesn't explicitly state "retrospective" or "prospective" for these tests, but non-clinical laboratory testing is typically conducted prospectively to meet specific requirements.

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 is not applicable to this type of medical device submission. Ground truth established by medical experts (like radiologists) is relevant for diagnostic AI/ML products, not for physical medical devices like insulin pen needles. The "ground truth" here is compliance with established international standards for device design, materials, and performance, which is verified through laboratory testing.

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 used in studies involving human readers or evaluators for diagnostic agreement, which is not relevant for the non-clinical testing of a physical device.

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-powered device, and no MRMC comparative effectiveness study was conducted or is relevant.

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.

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

The "ground truth" in this context is the compliance with recognized international standards (ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-1). This is established through specific laboratory tests and measurements designed to verify that the device meets the defined performance and safety criteria outlined in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

Ask a specific question about this device