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The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Syringes for Single Use with/without Needle are three-piece, sterile, single use hypodermic syringes with a 6% (Luer) male connector/lock fitting in various sizes. Each syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Sterile syringes for single use with/without needle). This document describes the device, its intended use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.

However, the document does not describe a study involving an AI/algorithm-driven device with human-in-the-loop performance, nor does it detail acceptance criteria and performance for such a device in the way requested by your prompt. The device cleared is a manual medical device (syringes), not an AI-powered diagnostic or therapeutic tool.

Therefore, many of the requested details regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.

Below is a breakdown of the relevant information found in the document, framed as closely as possible to your prompt's structure, along with clear statements about what information is not available given the nature of the cleared device:

Analysis of Acceptance Criteria and Study for the Sterile Syringes for Single Use with/without Needle

The acceptance criteria and study detailed in the provided FDA 510(k) summary pertain to the physical, chemical, and biological performance of a manual medical device (sterile syringes), not an AI-powered system. As such, information regarding AI-specific criteria, human reader improvement with AI assistance, or expert consensus on AI outputs is not present.

The study proves the device meets the acceptance criteria through demonstrating substantial equivalence to a legally marketed predicate device, primarily by showing compliance with recognized international and national standards for syrings and needles.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally established by compliance with a comprehensive set of recognized industry standards. The reported device performance is that it "meets the requirements" or "complies with" these standards.

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

The document does not specify exact sample sizes for each test mentioned (e.g., how many syringes were tested for each performance criterion). It generally states that "The Sterile Syringes for Single Use with/without Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body."

• Data Provenance: The testing was conducted by or on behalf of the manufacturer, Zhejiang Kangkang Medical-Devices CO., Ltd., based in China. The data would therefore originate from China and pertain to laboratory testing of the manufactured device. The studies described are prospective laboratory tests performed specifically for this submission.

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

This information is not applicable as the evaluation is based on compliance with harmonized standards for physical and chemical properties of a device, not on clinical interpretation or ground truth established by medical experts for diagnostic accuracy. The "ground truth" here is the pass/fail result against established standard specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical trials involving human interpretation of medical images or data, not for laboratory compliance testing of a physical medical device. The "adjudication" is the assessment of compliance with the specified test methods and criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists, pathologists). The device under review is a manual syringe, which does not involve human readers in this context or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This concept is completely irrelevant to a manual medical device like a syringe.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the specified physical, chemical, and biological requirements and test methods outlined in the referenced international and national standards (e.g., ISO 7886-1, ISO 10993, USP , etc.). For instance, for sterility, the ground truth is achieving a Sterility Assurance Level (SAL) of $10^{-6}$. For dimensions, the ground truth is meeting the specified dimensional tolerances. This is entirely lab-based and objective measurement.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (syringe), not an AI algorithm that requires a "training set."

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

This information is not applicable for the same reason as above. There is no AI training set.

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