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The YUE PFONG® Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.

The YUE PFONG® Safety Syringe (3ml) is sterile, single-use, disposable , Non-reusable, Manual , Retractable, 3ml Piston Syringe, provided with needle attached in place., which is used for injection of fluids into the body. (Needle Spec. including 1'/2" or shorter, 18-28 gauge). The YUE PFONG® Safety Syringe (3ml) consist of the following major components. 1 Plunger , 2 Barrel , 3 Piston, @ adaptor , $ O- Ring , 6 Needle & Needle Hub, 7 Needle Sheath.

This 510(k) summary describes a YUE PFONG® Safety Syringe (3ml). It is important to note that this document is for a medical device (syringe) and not a software algorithm, so some of the requested categories (e.g., training set, expert adjudication, MRMC study) are not applicable in the context of this submission. The "study" here refers to bench testing and simulated use studies for the physical device.

Here's a breakdown of the provided information, tailored to the context of a physical medical device submission:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the numerical sample size for the test set. It mentions "bench testing & simulated use study."

• Sample Size: Not specified numerically.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the submission is from YUE PFONG International Industrial Co., Ltd. in Taiwan, which implies the testing likely originated there or was conducted according to international standards. The studies would be considered prospective as they are specifically conducted to demonstrate compliance for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable to a physical medical device submission for a syringe. "Ground truth" in this context would refer to objective measurements and adherence to engineering and biological standards, not expert human interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable to a physical medical device submission for a syringe. The assessment is based on objective testing against established standards.

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 is not applicable as the device is a physical syringe, not an AI or software-driven diagnostic tool.

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

This is not applicable as the device is a physical syringe, not a software algorithm. The "standalone performance" of the syringe refers to its ability to perform its function (inject fluid, prevent sharps injury) independently, which is assessed through bench and simulated use testing.

7. The Type of Ground Truth Used

For a physical device like a syringe, the "ground truth" is defined by:

• Objective Measurements: Conformance to the physical, chemical, and sterilization specifications outlined in the referenced ISO and USP standards.
• Functional Performance: Successful operation during "bench testing & simulated use study" according to its intended use (e.g., proper retraction mechanism function, fluid delivery, sharps injury prevention).

8. The Sample Size for the Training Set

This is not applicable as the device is a physical syringe, not a machine learning model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for a physical medical device.

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