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The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries.

In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.

The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. is sterile, single-use, disposable and non-reusable, needle retractable safety syringe, provided with various size of needle.

The provided document is a 510(k) summary for the ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. This document establishes substantial equivalence to predicate devices based on similarities in intended use, design, technological, and operational characteristics, and references adherence to international standards. It does not contain information about a specific diagnostic study with acceptance criteria and device performance metrics, as is typical for AI/ML-based medical devices.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or available in this document.

However, I can provide available information regarding the device's performance summary based on the provided text.

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)

This information is not provided in the document. The document refers to meeting international standards (ISO standards), which implies performance testing, but does not detail the sample sizes, data provenance, or specific study designs for these tests.

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 information is not provided in the document. The document describes compliance with technical standards, not a diagnostic study involving expert ground truth establishment.

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

This information is not provided in the document.

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) comparative effectiveness study is not applicable to this device. The ClickZip™ Needle Retractable Safety Syringe is a physical medical device designed for insulin injection and needle stick prevention, not an AI/ML diagnostic tool involving human readers or interpretation.

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

This is not applicable to this device. The ClickZip™ Needle Retractable Safety Syringe is a physical medical device and does not involve an algorithm.

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

This is not applicable in the context of a diagnostic ground truth. For this type of device, "ground truth" would refer to the physical and functional characteristics meeting engineering specifications and safety requirements as defined by the ISO standards and the device's intended use (e.g., successful needle retraction, prevention of re-use, sterility, biocompatibility). These are verified through various physical, chemical, and biological tests, not typically through expert consensus on diagnostic images or pathology.

8. The sample size for the training set

This is not applicable to this device. There is no AI/ML algorithm involved.

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

This is not applicable to this device. There is no AI/ML algorithm involved.

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