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The Medline Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, this safety syringe is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse.

The Medline Retractable Safety Syringe is a retractable type piston syringe, designed to aid in the prevention of needle stick injuries. This single-use, disposable syringe consists of the following components:

1. Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user in affach a needle.
2. Plunger - Once the plunger is fully depressed, it engages the needle assembly. As the plunger is retracted, the needle assembly is retracted into the barrel. Once the plunger is fully retracted and locked in place, the plunger is snapped off leaving the needle in the barrel of the syringe.
3. O-Ring - The O-ring minimizes the risk of leakage around the adapter.
4. Gasket - The gasket maintains the fluid in the barrel between the adapter and plunger.
5. Luer Lock or Needle Holder - The luer lock facilitates passage of the fluid, while holding the needle in place.
6. Hub Holder - Engages the plunger after the injection.
7. Locking Ring - A plastic insert at the top of the barrel. After the injection, the health care professional retracts the plunger with the needle into the barrel. Once the plunger is fully retracted, the plunger is locked into position at the top of the barrel. This safety mechanism makes sure the needle cannot be pushed back out the tip of the barrel.
8. Needle - Pre-attached single lumen stainless steel needle which penetrates the patient's skin to inject/withdraw fluid. (1ml syringe only)
9. Short Cap - Protective cover for the needle tip. Removed upon use. (1ml syringe only)
10. Big Cap - Protective cover for the plunger. (1ml syringe only)
    The Medline Retractable Safety Syringe functions in a manner similar to standard syringes for fluid injection/withdrawal. After use, the health care professional fully depresses the plunger to engage the luer assembly. Once the luer assembly is engaged, pulling back the plunger causes the adapter and the attached needle to be withdrawn into the safety of the barrel. This retraction into the barrel of the syringe can be visually confirmed. In this position against the flange, single-handed lateral pressure on the plunger results in a controlled fracture of the plunger. Once this safety mechanism has been activated, the syringe is permanently disabled and the needle is completely secured within the barrel. Both the syringe and plunger are discarded in a Sharp's container.

This document describes a 510(k) submission for the Medline Retractable Safety Syringe, a medical device designed to prevent needlestick injuries. The submission focuses on substantial equivalence to predicate devices rather than a complex clinical study proving novel performance. Therefore, many of the requested sections related to clinical study specifics (such as MRMC studies, training set details, and expert qualifications for ground truth) are not applicable or explicitly stated in this type of regulatory submission for this device.

Here's the breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The "testing" mentioned refers to compliance with international standards (ISO standards), which typically involve laboratory testing of device attributes on a batch-by-batch or statistically representative sample basis. The sample size for these engineering and materials tests is not provided. Data provenance is not applicable as this describes physical product testing, not patient data.

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

Not applicable. Ground truth as typically defined for clinical studies or AI algorithm evaluation (e.g., expert consensus on medical images) is not relevant for this type of device submission and its associated testing. The "ground truth" for compliance with ISO standards is the standard itself and its specified test methods and acceptance limits.

4. Adjudication method for the test set

Not applicable. No expert adjudication process for clinical data is described.

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 is a physical medical device (syringe), not an AI algorithm for diagnostic interpretation. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

Not applicable. This is a physical medical device.

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

For the compliance testing against ISO standards, the "ground truth" is defined by the objective metrics and specifications within those standards (e.g., force required for retraction, leakage rates, material specifications). For the claim of substantial equivalence, the "ground truth" is the performance and technological characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. There is no "training set."

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