Search Results

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

The provided text describes the submission for an Insulin Pen Needle for 510(k) clearance, intending to prove substantial equivalence to a predicate device, not an AI/ML-based medical device. Therefore, many of the requested criteria related to AI/ML model evaluation (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable to this submission.

However, I can extract information regarding the device's performance criteria and how its compliance was demonstrated through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, focusing on the relevant sections for a non-AI/ML device:

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

The acceptance criteria for the Insulin Pen Needle are primarily based on compliance with established international standards for medical devices, specifically needles and injection systems. The reported device performance is that it complies with these standards.

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

The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." However, it does not specify the sample sizes used for these non-clinical tests. The tests were performed to demonstrate compliance with international standards, which typically involve specific sample size requirements as part of the test methodology outlined in those standards. The data provenance is internal testing performed by the manufacturer (Wenzhou Beipu Science & Technology Co., Ltd) implicitly in China, as that is their location. These would be prospective tests performed specifically for this submission.

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 as this is a physical medical device, not an AI/ML model requiring expert annotation for ground truth. Compliance with performance standards is typically measured by laboratory testing according to defined protocols, not expert consensus on images or data.

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

Not applicable for a physical device's performance testing. Test results are typically objective measurements against a defined standard.

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 device.

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

Not applicable. This is not an algorithm. The "standalone" performance here refers to the device's inherent performance as measured by physical and biological tests against established standards.

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

The "ground truth" for this device's performance is compliance with established, objective, and predefined engineering, materials, and biological standards (e.g., ISO, ASTM, USP). This is demonstrated through laboratory testing, not human expert interpretations or clinical outcomes data in the way an AI model would be validated.

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.

Ask a specific question about this device