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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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Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

BAIXIN™ Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. This device is sterile and for single use only.

The provided text describes the acceptance criteria and the summary of testing for the "BAIXIN™ Intravascular Administration Set". However, it does not detail a study in the context of AI/ML devices or clinical trials that would typically involve a "test set," "training set," "ground truth experts," or "MRMC comparative effectiveness studies." The document is a 510(k) summary for a medical device that conforms to recognized consensus standards, specifically ISO 8536-4-2007.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and review process described.

Here's the information that can be extracted or inferred:

Acceptance Criteria and Reported Device Performance

Note on Reported Device Performance: The document states, "Anhui Kangda Medical Products Co., Ltd. has established that its family of syringes conform to the FDA recognized consensus standard, ISO 8536-4-2007, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed. Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Ltd." The "Summary of Testing" lists the requirements, implying that the device met these requirements without explicitly providing numerical results for each test within this summary. Therefore, "Conforms (Implied)" is used as the reported performance.

1. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. The document refers to "All materials used in the fabrication... were evaluated," but does not give a specific sample size for each test.
• Data Provenance: Not explicitly stated, but the manufacturer is Anhui Kangda Medical Products Co., Ltd. in P. R. China. The testing was conducted to conform to ISO 8536-4-2007. The tests are likely performed by the manufacturer or a contracted lab in China.

2. 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 and submission. The "ground truth" for this device is defined by the technical specifications and performance criteria outlined in the ISO standard, and demonstrated through physical, chemical, and biological testing, rather than expert interpretation of medical images or data.

3. Adjudication method for the test set:

• Not applicable. This concept relates to disagreement resolution among experts in medical image interpretation or clinical diagnosis, which is not relevant for the conformance testing of an intravascular administration set.

4. 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:

• No, this was not done. MRMC studies are used for evaluating diagnostic or screening devices, particularly those involving human readers (e.g., radiologists) and potentially AI assistance. This device is a fluid administration set, not an AI/ML diagnostic tool.

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

• Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:

• The "ground truth" for this device is established by technical specifications, chemical analysis, physical testing, and biological assays (e.g., sterility, pyrogenicity, toxicity, dimensional correctness) as defined by the international consensus standard ISO 8536-4-2007.

7. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" as this is not an AI/ML device.

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