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The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.

BAIXIN Disposable Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.

The provided text describes the acceptance criteria and the summary of testing for the BAIXIN™ Disposable Syringe. It focuses on the device's adherence to ISO 7886-1:1993, a consensus standard for sterile hypodermic syringes.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Ltd." which implies that the device met all the listed acceptance criteria. No specific numerical results are provided for the "Reported Device Performance" column beyond the criteria themselves.

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

• Sample Size: The document does not specify the sample size used for the testing. It only mentions "All materials used in the fabrication... were evaluated".
• Data Provenance: The testing was performed by Anhui Kangda Medical Products Co., Ltd. in China. The data would be considered retrospective in the context of this 510(k) submission, as the tests were conducted prior to the 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 to this type of device. The "ground truth" for a disposable syringe is established by objective physical and chemical testing against a recognized standard (ISO 7886-1:1993), not by expert consensus or interpretation of complex data.

4. Adjudication Method for the Test Set

This information is not applicable. The testing involves objective measurements against predefined thresholds from a standard, not subjective interpretations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical image analysis or diagnostic devices where human readers interpret results, and an AI's impact on their performance is being evaluated. This is not applicable to a disposable syringe.

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

No, a standalone (algorithm-only) performance evaluation was not done. The device is a physical medical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurements and chemical/biological tests against the specific requirements and limits defined in the international consensus standard ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of testing a physical medical device like a disposable syringe. This concept applies to machine learning algorithms.

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

This information is not applicable for the same reason as #8.

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