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The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The Sterile Hypodermic Syringe is a sterile, single-use, polypropylene syringe that consists of the barrel, plunger, and stopper and is assembled with a hypodermic needle.

The Sterile Hypodermic Needle is a single lumen needle made of austenitic steel, consisting of a protective cap, a needle seat and a needle tube connection.

This document describes the FDA 510(k) premarket notification for a Sterile Syringe for Single Use (with Needle) and a Sterile Hypodermic Needle for Single Use by Jiangsu Zhiyu Medical Instrument Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K201284).

However, the provided text does not contain details about a study conducted to prove the device meets acceptance criteria in the context of an AI/human reader performance study. The document is a regulatory submission for a physical medical device (syringes and needles) and focuses on demonstrating substantial equivalence through bench testing (per ISO standards) and biocompatibility testing.

Therefore, I cannot provide the information requested in your prompt regarding:

• A table of acceptance criteria and reported device performance related to AI/human reader studies. The acceptance criteria discussed pertain to physical properties and safety of the syringe/needle, not diagnostic performance.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for ground truth establishment for an AI study.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study results (AI vs. without AI assistance).
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for an AI study.
• Sample size for the training set (for an AI model).
• How ground truth for the training set was established (for an AI model).

The document explicitly states: "No clinical study is included in this submission." This further confirms that no studies involving human reader performance comparisons or algorithm-only performance for diagnostic purposes (the typical context for MRMC or standalone AI studies) were conducted or submitted.

What the document DOES provide regarding acceptance criteria and performance:

The acceptance criteria for these devices are based on adherence to recognized international and US standards for medical devices, primarily ISO standards and USP. The "study" proving the device meets these criteria refers to bench testing, biocompatibility testing, and sterilization validation.

Here's a summary of the actual acceptance criteria and performance demonstrated (not a diagnostic AI study):

1. Table of Acceptance Criteria and Reported Device Performance (as per the document):

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

• For physical and performance testing, the sample sizes would be based on the specific ISO standards and industry best practices for device testing, typically involving a statistically significant number of units to ensure consistency and reliability. The exact numbers are not provided in this summary document.
• Data provenance: This is a submission from Jiangsu Zhiyu Medical Instrument Co., Ltd. in China. The tests are internal company tests conducted to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth and their qualifications:

• Not applicable in the context of this document. Ground truth for this type of device is established by adherence to engineering specifications and performance standards through laboratory testing, not expert clinical interpretation of images or patient data.

4. Adjudication method for the test set:

• Not applicable. Adjudication is relevant for subjective assessments, typically in clinical readings or AI ground truth labeling. Bench testing results are objective measurements against defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states: "No clinical study is included in this submission."

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

• No. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" for this device's performance is defined by the specifications and acceptable limits set forth in the referenced ISO and USP standards. This includes, for example, specific force required to move a plunger, volume accuracy, needle sharpness, and biocompatibility limits. It is established through physical measurements and laboratory assays.

8. The sample size for the training set:

• Not applicable. This device does not use a training set as it is not an AI/ML device.

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

• Not applicable.

In summary, the provided document is for a conventional medical device (syringes and needles) seeking 510(k) clearance based on substantial equivalence to a predicate device, demonstrated through rigorous bench testing and adherence to recognized performance and safety standards, not through AI performance studies.

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