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

The subject device, Disposable Insulin Pen Needle, is a single-use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, inner sheath, outer sheath, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The subject device is not intended for neonates, newborn infants or children. The subject device is used in conjunction with following pen injector during clinical use.

This document is a 510(k) Summary for a Disposable Insulin Pen Needle. It does not describe an AI/ML medical device, but rather a physical, single-use medical device. Therefore, the questions related to AI/ML device performance, such as MRMC studies, training/test sets, and ground truth establishment, are not applicable.

The acceptance criteria and proof of "performance" for this device are demonstrated through non-clinical bench testing to show compliance with various international standards and substantial equivalence to a predicate device.

Here's an interpretation based on the provided document, restructured to address the questions where applicable for a non-AI/ML device:

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

For a physical device like a pen needle, "acceptance criteria" are generally compliance with relevant standards and demonstration of substantial equivalence to a predicate device. The "reported device performance" refers to the results demonstrating this compliance.

• ISO 10993-5:2009 (Cytotoxicity)
• ISO 10993-10:2010 (Irritation and skin sensitization)
• ISO 10993-11:2006 (Systemic toxicity)
• ASTM F756-13 (Hemolytic properties) | Patient-contact materials meet requirements of these standards |
  | Sterility Assurance Level (SAL) | EO sterilized, SAL: 10^-6 |
  | Single Use Compliance | Designed and labeled for single use |
  | Labeling Compliance | Conforms with 21 CFR 801 |
  | Substantial Equivalence to Predicate Device (K152824) | Achieved through non-clinical bench testing and comparison of technological characteristics |

2. Sample sized used for the test set and the data provenance

The document states "Non-clinical tests were conducted..." but does not specify the sample sizes for these tests. Data provenance is implied to be from the manufacturer's internal testing in China (Jiangsu Caina Technology Co., Ltd. is based in China), as is typical for 510(k) submissions focusing on bench testing. The tests are "non-clinical," meaning they are not performed on human subjects and are simulated or lab-based.

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

This question is not applicable as there is no "ground truth" in the context of an AI/ML system or a clinical test set in this document. The "ground truth" for a physical device is its adherence to a standard's specifications as verified by laboratory testing.

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

This question is not applicable for the type of bench testing described. Adjudication methods are relevant for human expert review, typically in clinical studies or image interpretation.

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 question is not applicable. This document details the submission for a physical medical device (pen needle), not an AI-assisted diagnostic or therapeutic device.

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

This question is not applicable as it pertains to AI/ML algorithms.

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

As explained in point 3, the concept of "ground truth" for this device relates to compliance with established international and ASTM standards as measured through instrumental and chemical analyses in a laboratory setting. There is no biological or expert consensus ground truth defined in the context of this device's performance evaluation for a 510(k).

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

This question is not applicable. There is no "training set" or "ground truth" for a training set.

In summary: The provided document is a 510(k) summary for a Disposable Insulin Pen Needle. Its "acceptance criteria" and "proof of performance" are entirely based on non-clinical bench testing and adherence to recognized international and ASTM standards, along with demonstrating substantial equivalence to a previously cleared predicate device. The concepts of AI/ML performance evaluation, such as training/test sets, human readers, ground truth establishment by experts, and MRMC studies, are not relevant to this type of device submission.

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