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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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The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular of The ChekZip - Needle Ketractaons into a patient and is intended to prevent needle stick subcutaneous injection of medications into a patient and is intended on the subcutaneous injection of medications into a partificant (1) Needle Retractable injuries. It is currently available in Imal for withdrewing blood In addition when the injuries. It is currently available in this only and simbleding blood. In addition, when the Safely Syringe 13 not intenably the syringe is prevented.

The ClickZip™ Needle Retractable Safety Syringe is sterile, single-use, disposable and nonreusable, needle retractable safety syringe, provided with various size of needle. The products are supplied in many sizes i.e. 1, 3 and 5 ml.

The prompt provided describes a 510(k) premarket notification for a medical device called the "ClickZip™ Needle Retractable Safety Syringe." This document outlines the device's characteristics, intended use, and claims of substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria, as one would typically find for performance testing.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:

• Intended Use: Used for intramuscular or subcutaneous injection of medications to prevent needle stick injuries, and not for withdrawing blood.
• Design, Technological, and Operational Characteristics: Sterile, single-use, disposable, non-reusable, and supplied with various needle sizes (1, 3, and 5 ml).
• Compliance with Recognized Standards: The document states that the device "has been shown to meet internationally recognized standards for syringe performance i.e. ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11135. These include physical specification, chemical specification, and biocompatibility and sterilization specification."

There is no detailed information regarding a specific study conducted with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. The 510(k) process often relies on demonstrating equivalence through comparison to a legally marketed predicate device that has already established safety and effectiveness, rather than requiring extensive de novo clinical or performance studies for every new submission, especially for devices with well-understood risks like syringes.

Therefore, I cannot populate the table or answer most of the specific questions because the provided text does not contain this level of detail about a performance study with acceptance criteria.

Based on the provided text, here is what can be inferred and what is explicitly missing:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided in the document. The document mentions compliance with ISO standards, which would imply testing, but does not detail the sample sizes or provenance of any such test data.

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)

• Not applicable / Not provided. The document describes a medical device, not a diagnostic algorithm that relies on expert consensus for ground truth.

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

• Not applicable / Not provided. This is not relevant for the type of device and performance information presented.

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

• No. This is not an AI/diagnostic imaging device.

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

• No. This is not an AI/diagnostic imaging device.

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

• Not applicable / Not provided. For a syringe, performance is typically assessed against engineering specifications, material properties, and functional tests outlined in international standards, not against "ground truth" as conceptualized for diagnostic devices.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device.

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

• Not applicable / Not provided. This is not an AI/machine learning device.

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