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

The provided text is a 510(k) Summary for a medical device (Sterile High-pressure Angiographic Syringes for Single-use). It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in a clinical setting.

Therefore, I cannot provide information regarding:

• Acceptance Criteria and Reported Device Performance for clinical outcomes: The document focuses on performance specifications (e.g., pressure, sterility, biocompatibility) of the device components, not clinical performance metrics or specific acceptance criteria for a clinical study.
• Sample size for the test set and data provenance: No clinical test set is described. The "test set" here refers to samples used for non-clinical engineering and biological tests.
• Number of experts and qualifications, and adjudication method: These pertain to clinical studies with a ground truth established by experts, which is not applicable here.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This is a type of clinical study not performed or referenced in this document.
• Effect size of human readers with/without AI assistance: This is irrelevant as the device is a syringe and connection tube, not an AI-assisted diagnostic tool.
• Standalone (algorithm only without human-in-the-loop performance): This is also irrelevant for this type of medical device.
• Type of ground truth used: Ground truth, typically defined by expert consensus or pathology in a clinical context, is not applicable here. The "ground truth" for these non-clinical tests is adherence to established engineering and biological standards.
• Sample size for the training set and how the ground truth for the training set was established: These concepts are related to machine learning and AI, which are not relevant to the described device.

What the document does provide in relation to "acceptance criteria" and "study that proves the device meets the acceptance criteria" (within the scope of a 510(k) for a physical medical device):

The document details a series of non-clinical tests performed to demonstrate that the proposed device meets established performance standards and is substantially equivalent to a predicate device. These standards effectively act as the "acceptance criteria" for the device's design and manufacturing.

Here's a summary of the non-clinical acceptance criteria (standards/tests) and the reported performance:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)

2. Sample size used for the test set and the data provenance:

• The document does not specify the exact sample sizes (number of units) used for each non-clinical test. It generally states that "Non clinical tests were conducted."
• The data provenance is from non-clinical laboratory testing performed by the manufacturer (Shenzhen Boon Medical Supply Co., Ltd) in China, as per the sponsor identification. These are not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth in this context refers to established engineering and biological standards (e.g., ISO, ASTM, USP), not expert clinical adjudication. Compliance with these standards is determined by trained technicians/engineers through validated testing methods.

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

• Not applicable. This concept relates to multi-expert clinical review, which is not relevant for non-clinical device testing verifying adherence to standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is not relevant to a sterile syringe product.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" for proving it meets "acceptance criteria" is adherence to recognized international and national standards for medical device performance, biocompatibility, and sterility (e.g., ISO 7886, ISO 594, ISO 10993, ASTM F88, USP monographs).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

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