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The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. It is intended to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

The TERUMO® 30 Gauge hypodermic needle is comprised of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

This document describes the 510(k) submission for the TERUMO® 30 Gauge Hypodermic Needle. This is a claim of substantial equivalence to predicate devices, not for a novel device requiring extensive clinical trials. Therefore, much of the requested information (like multi-reader multi-case studies, effect sizes, expert qualifications, and ground truth establishment for AI models) is not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly state quantitative acceptance criteria with numerical targets. Instead, performance is evaluated by demonstrating that the new device performs comparably to the predicate device and does not raise new safety or effectiveness concerns. The "reported device performance" is a qualitative statement of successful testing.

The study essentially concludes that "None of the data raises any new issues of safety and effectiveness."

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

The document does not specify the sample sizes used for each of the performance tests (Cannula Adhesion, Protector Fit, etc.). The data provenance is not explicitly mentioned as country of origin, retrospective, or prospective. However, based on the nature of the tests, they would be prospective laboratory tests conducted on samples of the newly designed 30 Gauge Hypodermic Needle.

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

Not applicable. This is a submission for a medical device (hypodermic needle), not an AI algorithm requiring expert ground truth in image interpretation or diagnosis. The "ground truth" for these performance tests is derived from standard engineering and biocompatibility testing methodologies.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process is described for the performance tests of a hypodermic needle.

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. The device is a hypodermic needle, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a hypodermic needle, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests comes from:

• Engineering Specifications: For tests like Cannula Adhesion, Protector Fit, Needle Penetration Force, Leakage, and Blocked Cannula, the ground truth is against defined engineering standards and acceptable ranges for these physical properties.
• Regulatory Standards: For sterility (ANSI/AAMI/ISO 11137-1994) and pyrogenicity (US Pharmacopoeia XXIII, LAL test), the ground truth is adherence to these established regulatory and testing standards.
• Predicate Device Equivalence: For biocompatibility, the ground truth is the established biocompatibility of the predicate device (K771203) using the same materials and sterilization methods.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for one.

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