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Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

The proposed devices include 2 models of plastic, disposable syringes and 5 connection tubes of different specifications. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes are used to connect the syringe and the catheter. The tubes are also available in three configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe), they can withstand maximum pressure of 400 psi. The proposed devices are used with the J shape tube / spike cleared in K151960.

The provided FDA 510(k) summary (K182289) describes the substantial equivalence of Sterile High-pressure Angiographic Syringes for Single-use to a predicate device, focusing on mechanical and material properties rather than AI/algorithm performance. Therefore, most of the requested information regarding AI acceptance criteria, study design (MRMC, standalone), ground truth establishment, and training/test set details for AI models is not applicable to this document.

The document primarily addresses the physical and functional characteristics of a medical device (syringes and connection tubes) and its compliance with relevant international standards.

However, based on the non-clinical tests described, we can infer a form of acceptance criteria and the "study" (non-clinical testing) that proves the device meets these criteria.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (Non-AI Medical Device)

Explanation of "Study" Proving Acceptance Criteria (Non-Clinical Testing):

The "study" here refers to non-clinical bench testing conducted to verify the device's technical specifications and compliance with relevant standards.

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

   • Sample Size: Not explicitly stated as a number of units tested. The document mentions "The test samples of syringe 100104 and 100114 with accessories are tested for liquid leakage and flow characteristics." This implies a series of physical tests on multiple units of the specified models. Regulatory submissions for devices of this nature typically involve testing a statistically representative sample size, but the exact number isn't provided in this summary.
   • Data Provenance: The tests were conducted internally by the manufacturer, Shenzhen Baoan Medical Supplies Co., Ltd. (China). The data is retrospective in the sense that it was collected as part of product development and validation prior to submission.

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

   • Not Applicable. For a medical device like a syringe, "ground truth" is established through engineering specifications, material science, and performance standards, not through expert consensus on medical images or diagnoses. The "truth" is whether the device meets the physical and functional requirements (e.g., does it leak at 400 psi? Does it conform to luer taper dimensions?). These are objective measurements not requiring expert clinical adjudication.

3. Adjudication Method for the Test Set:

   • Not Applicable. As mentioned above, the tests are objective, measurable physical and mechanical tests. There is no subjective interpretation requiring adjudication by multiple readers or experts.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is a clinical study design typically used for diagnostic devices (like imaging AI) to assess the impact of a new technology on human reader performance. This document concerns a physical device (syringe), not a diagnostic tool or AI.

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

   • No. This is not an AI/algorithm. This question is irrelevant to the device described.

6. The Type of Ground Truth Used:

   • Engineering Specifications and International Standards: The ground truth for this device's performance is defined by adherence to established international standards (ISO 594-1, ISO 594-2, ISO 7886-1, ISO 7886-2, ISO 10993 series) and the manufacturer's own design specifications (e.g., target resistant liquid leak pressure). This is a physical/mechanical "ground truth."

7. The Sample Size for the Training Set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are based on engineering principles and established device standards, not trained data.

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

   • Not Applicable. Again, this is not an AI/machine learning device. "Ground truth" for manufacturing and design would be derived from engineering drawings, material specifications, and regulatory requirements rather than labeled training data.

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