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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 US legally marketed angiographic injectors.

The subject devices are identical to all models of predicate devices of K192657. It includes disposable syringes, connection tube, J shape tube and spike. Labeling of subject device now includes pediatrics in the patient population.

This document is a 510(k) summary for Sterile High-pressure Angiographic Syringes for Single-use. It primarily focuses on demonstrating substantial equivalence to a predicate device (K192657) and does not contain information about a study proving specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for AI/ML technologies.

This type of submission typically demonstrates the device meets a set of performance standards or specifications, rather than a "study that proves the device meets the acceptance criteria" in the way a clinical trial or AI performance study would. The acceptance criteria here relate to physical, chemical, and biological properties, as well as compatibility.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details, are not applicable to this type of device submission.

Here's the available information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests and standards that the device complies with, along with some performance 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 does not specify sample sizes for the individual non-clinical tests (e.g., number of syringes tested for pressure, number of samples for biocompatibility).
• Data provenance: Not explicitly stated, but the submission is from Shenzhen Boon Medical Supply Co., Ltd. in China, suggesting the tests were likely conducted in China. The submission itself is dated August 13, 2021, and received August 23, 2021, implying these are retrospective test results for device validation.

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)

• This is not applicable. The "ground truth" for this medical device (angiographic syringes) involves meeting engineering specifications and biological safety standards, not diagnostic interpretations that require expert consensus. The compliance is against defined standards (e.g., ISO, ASTM, USP) and internal specifications.

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

• This is not applicable for this type of device. Adjudication methods are typically used in clinical studies for diagnostic accuracy, where disagreements between readers or algorithms need resolution. Here, the tests yield objective pass/fail results against established criteria.

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

• This is not applicable. The device is a physical medical instrument (syringe), not an AI/ML diagnostic or assistive tool.

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

• This is not applicable. The device is a physical medical instrument (syringe), not an AI/ML algorithm.

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

• The "ground truth" in this context is defined by international and national standards (e.g., ISO 10993, ASTM F88, USP 41) and the device's own engineering specifications (e.g., maximum pressure resistance, volume, material properties). Compliance is measured against these objective criteria.

8. The sample size for the training set

• This is not applicable. There is no AI/ML component, therefore no "training set."

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

• This is not applicable. There is no AI/ML component, therefore no "training set" ground truth.

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