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Verifine Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Additionally, after withdrawal of the Verifine Safety Type Insulin Pen Needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.

Verifine Safety Type Insulin Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin.

The Verifine Safety Type Insulin Pen Needle consists of needle tube, trigger shield, spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.

The user proceeds with inserting the needle into the skin manually. Verifine Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.

Verifine Safety Type Insulin Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.

This document is a 510(k) premarket notification for the Verifine Safety Type Insulin Pen Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria, especially points 2-9, cannot be fully provided from the given document as it does not detail a study designed to establish such performance metrics with specific acceptance criteria in the manner requested for a novel device.

The document primarily focuses on bench testing against international standards and biocompatibility testing to demonstrate that the proposed device performs comparably to the predicate and is safe.

Here's an attempt to extract the relevant information where available, with explicit notes on what is not provided by the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines acceptance criteria by compliance with recognized international standards for medical needles and sharps injury protection. It states that the device "Complied with" these standards, indicating their requirements serve as the acceptance criteria.

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

• Sample Size for Test Set: Not explicitly stated for each test. The document refers to "bench testing" and "biocompatibility testing" but does not detail the number of units tested.
• Data Provenance: Not explicitly stated, but it would be from the manufacturer's internal testing facilities as implied by the "Performance Testing Summary" and "Biocompatibility" sections. It is not described as involving external clinical data or specific geographic regions. It is a retrospective summary of testing performed by the manufacturer.

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

• Not Applicable / Not Provided. This type of information is typically relevant for studies involving subjective expert review (e.g., image interpretation). For bench testing against engineering standards and biocompatibility, the "ground truth" is established by the specifications of the standards themselves and objective measurements, not by expert consensus in the typical sense of a human-in-the-loop study.

4. Adjudication method for the test set

• Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are used for studies where multiple experts independently assess data and discrepancies need to be resolved. This document describes objective engineering and biological tests against established standards, not a subjective assessment requiring adjudication.

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 device is an insulin pen needle, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

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

• Not Applicable. Again, this is a physical medical device, not an algorithm. Standalone performance as described (algorithm only) is not relevant. The "standalone" performance here would refer to the device's ability to meet the specified performance standards on its own.

7. The type of ground truth used

• Standard Specifications and Laboratory Measurements. The "ground truth" for the performance testing is defined by the requirements and test methods outlined in the cited ISO and ASTM standards (e.g., ISO 9626 for needle tubing, ISO 11608-2 for injection systems, ISO 23908 for sharps protection, ISO 10993 series for biocompatibility). The device performance is measured against these objective, verifiable specifications in a laboratory setting.

8. The sample size for the training set

• Not Applicable / Not Provided. This refers to a "training set" in the context of machine learning or AI. This device is a physical product and does not involve AI development or training sets.

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

• Not Applicable / Not Provided. (See point 8).

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