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The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.

The provided text describes a 510(k) premarket notification for "NIPRO Disposable Syringe with or without needle." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study design for a novel device. Therefore, much of the requested information (sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission and is not present in the provided text.

The core of this submission is a comparison of technical characteristics and performance to legally marketed predicate devices, with the goal of showing they are "substantially equivalent."

Here's the information that can be extracted or derived from the provided text, with explanations where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Not Applicable. The document describes performance tests to demonstrate substantial equivalence to voluntary standards, but it does not detail a specific "test set" or study in the manner requested (e.g., a clinical trial or a performance study with a distinct sample size of patients/cases). The "performance tests" are likely internal engineering and quality testing to ensure the device meets specified manufacturing and product standards rather than a clinical performance study.
• Data Provenance: Not specified, but likely refers to internal testing data generated by Nipro Medical Corporation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This type of information is relevant for studies where expert consensus or interpretation is used to establish "ground truth" (e.g., in diagnostic devices). For a disposable medical device like a syringe, "ground truth" typically relates to its physical and functional performance meeting established engineering and safety standards, rather than expert interpretation of data.

4. Adjudication Method

• Not Applicable. As no expert review or "ground truth" adjudication process in the requested sense is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is typically done for diagnostic imaging devices or algorithms where human readers are making interpretations. It is not relevant for a disposable hypodermic syringe.

6. Standalone (Algorithm Only) Performance Study

• No. Syringes are mechanical devices; there is no embedded algorithm. "Standalone performance" here refers to the device's physical function. The document states that "Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes," which implies standalone testing of the device's physical properties and function. However, no specific metrics or study details are provided beyond this general statement.

7. Type of Ground Truth Used

• For the performance tests mentioned, the "ground truth" would be established by engineering specifications, recognized voluntary standards (e.g., ISO standards for syringes), and relevant regulatory requirements for physical and mechanical performance (e.g., plunger force, leak-tightness, sterility, material compatibility). The document states the device "meet voluntary standards for syringes," implying these standards serve as the "ground truth" for performance.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not part of a disposable syringe. Device validation for manufacturing would involve process validation and testing of production lots, rather than a "training set."

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

• Not Applicable. See point 8.

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