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Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.

The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube, and spike.

Syringe: The syringes are intended to be used with an U.S. legally marketed angiographic injector.

Compatibility is shown in the Table 1 Compatibility between Syringe and Injectors. (Note: the newly added and the difference between K211564 and the proposed device is highlighted in Red.)

Connection tube: it is used to connect the syringe and the catheter. The tubes (extension tube) are also available in various configurations, which are Type B (used with single shot syringe, highlighted in Red mark), renamed "Straight tube" to "Type B" and added a new model (400204) connecting tube in the Table. The product structure, manufacturing process, product materials have not changed. Type Y and type T tube are used with dual shots syringe. The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube. (Note: the newly added and the difference between K211564 and proposed device is highlighted in Red)

J shape tube: it is used to draw contrast media/saline into the syringe barrel before installation.

Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installation. The pressure specification for the spike is provided in the following table as Table 3 Pressure Specifications for Spike (Note: this model is only used to distinguish whether it is made with or without DEHP). The product materials, manufacturing process and product structure have not changed. Spikes not made with DEHP are marked with Red. The new additions of spike models are: 700204- 1, 700204-2,700205-1, 700205-2, 700206, 700207-1, 700207-2)

This document is an FDA 510(k) summary for a medical device, specifically Single-use Sterile High-pressure Angiographic Syringes and Accessories. It outlines the comparison between the proposed device and a legally marketed predicate device to establish substantial equivalence.

Important Note: This document describes a medical device clearance process for physical hardware (syringes and accessories), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI/MRMC studies, expert consensus on images, ground truth for training/test sets, etc., are not applicable to this type of submission. The 'acceptance criteria' here refer to meeting engineering and biocompatibility standards, and 'proving the device meets the acceptance criteria' is done through non-clinical laboratory testing.

Here's an attempt to answer your questions based on the provided text, while acknowledging that many are not relevant for this device type:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily defined by adherence to recognized international and ASTM/USP standards for medical devices and the ability to withstand specified pressures. The reported performance confirms compliance with these standards and pressure specifications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states "Nonclinical tests were conducted to verify that the proposed device met all design specifications." and refers to compliance with ISO, ASTM, and USP standards. However, specific sample sizes for each non-clinical test are not disclosed in this summary. The data provenance is internal testing conducted by Shenzhen Boon Medical Supply Co., Ltd. (China). This would be prospective, laboratory-based testing of manufactured units, not retrospective analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This is a hardware medical device; no "ground truth" based on expert medical opinion (like for imaging diagnosis) is established for the purpose of these non-clinical tests. The "truth" is whether the device meets engineering specifications and safety standards as measured by laboratory equipment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. As this is a hardware device undergoing non-clinical engineering and biological safety tests, there is no adjudication process involving multiple human reviewers for a "test set" in the context of diagnostic accuracy. Test results are objective measurements against defined standards.

5. 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

Not Applicable. This device is a physical syringe and accessories, not an AI software or system that assists human readers in diagnosis. No MRMC study was performed.

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

Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is defined by international, national, and industry-recognized standards and specifications (e.g., ISO, ASTM, USP) for medical device performance, safety, and biocompatibility. Compliance is determined by objective laboratory measurements and tests against these established benchmarks.

8. The sample size for the training set

Not Applicable. As this is a hardware device, there is no "training set" in the context of machine learning or AI.

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

Not Applicable. There is no training set.

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