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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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The proposed device is intended for the injection of contrast media or saline. This syringe use with US legally marketed angiographic injectors.

The proposed devices are available in packs, which may include different configurations of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube. J shape tube, which is used to draw contrast media/ saline into the syringe barrel. Spikes, which are used to draw contrast media/saline into the syringe barrel.

The provided document is a 510(k) premarket notification for a medical device: "Sterile High-pressure Angiographic Syringes for Single-use". This type of submission focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.

As such, the document does not describe a study to prove the device meets acceptance criteria in the way you've outlined for an AI-powered diagnostic device. Instead, it details non-clinical tests to show the proposed device performs comparably to the predicate and meets relevant engineering standards.

Therefore, many of your requested points regarding Acceptance Criteria and Study Proof (especially related to AI, MRMC, expert consensus, and ground truth establishment) are not applicable to this 510(k) submission for a non-AI medical device.

However, I can extract the relevant information from the document regarding the "acceptance criteria" (in the sense of standards compliance and comparative performance) and the "study" (non-clinical tests) that proves these criteria are met.

Here's a breakdown based on the provided document:

Device: Sterile High-pressure Angiographic Syringes for Single-use

Device Type: Non-AI Medical Device (Angiographic Syringes)

Study Purpose: To demonstrate Substantial Equivalence (SE) to a predicate device (Shenzhen BaoAn Medical Supplies Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use, K151960) through non-clinical testing and comparison.

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

For a non-AI device like this syringe, "acceptance criteria" primarily refer to adherence to recognized international standards and demonstration of comparable performance to a predicate device. "Reported device performance" is the outcome of non-clinical tests demonstrating compliance.

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

• Sample Size: The document does not explicitly state the number of units/samples used for each non-clinical test (e.g., how many syringes were tested for seal strength, or how many batches for endotoxin). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The specific number of test replicates/samples would typically be detailed in the full test reports, which are not part of this summary document.
• Data Provenance: The tests are non-clinical (laboratory/bench testing) performed to verify compliance with standards. The company "Youwo (Guangzhou) Medical Device Co., Ltd." is based in Guangzhou, P.R. China, implying the testing was conducted in China, likely at their own facilities or certified labs in China. The data is entirely lab-generated, not from human subjects. The nature of the testing is prospective, in the sense that the tests were performed specifically for this submission on new device samples.

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 non-AI, non-diagnostic medical device. There is no concept of "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance of these syringes is defined by the objective pass/fail criteria of the recognized engineering and biocompatibility standards (e.g., is the seal strong enough? Is there pyrogen presence?). Compliance is measured by laboratory equipment and established protocols, not expert human review of an image or signal.

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

• Not Applicable. As per point 3, there's no human diagnostic interpretation to adjudicate. Test results are objective measurements against pre-defined thresholds from 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 not an AI diagnostic tool, nor is it intended to assist human readers in interpreting medical cases. No MRMC study was conducted.

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

• Not Applicable. This is not an algorithm or AI device. Standalone performance refers to the device's ability to meet its specifications independently, which is what the non-clinical tests implicitly demonstrate (e.g., a syringe's seal strength is measured independently of human operation).

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

• Standards-Defined Ground Truth: The "ground truth" here is the adherence to internationally recognized performance and safety standards (e.g., ISO, ASTM, USP). The device is "true" if it passes the specified tests according to the criteria defined within those standards. For example, a "true" biocompatible device produces no cytotoxicity according to ISO 10993-5. This is determined by laboratory measurements and chemical/biological assays, not clinical outcomes or expert diagnostician consensus.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device. There is no training set.

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

• Not Applicable. This is not an AI/machine learning device. No ground truth for a training set was established.

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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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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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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 are available in packs, which may include different configurations of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1.

The provided document is a 510(k) summary for the Shenzhen Baoan Medical Supplies Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use. This type of submission is for medical devices, and the "acceptance criteria" and "device performance" primarily refer to compliance with recognized standards and biocompatibility, rather than clinical efficacy or diagnostic accuracy.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various international and national standards that the device complies with, which serve as the acceptance criteria for its non-clinical performance and safety. The reported device performance is that it "complies with" these standards.

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

The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications..." and lists various standards for these tests. However, it does not specify the sample sizes used for these non-clinical tests (e.g., number of syringes tested for seal strength or internal pressurization). The data provenance is generally from laboratory testing performed by the manufacturer to demonstrate compliance with the listed standards. No country of origin is explicitly stated for the testing itself, but the manufacturer is based in China. The data is prospective in the sense that the manufacturer conducted these tests to support the 510(k) submission.

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

This type of information is not applicable to this 510(k) submission. The document focuses on the engineering and material safety aspects of a medical device (angiographic syringes), not on diagnostic accuracy where expert ground truth would be established. The "ground truth" here is compliance with established engineering and biological safety standards, which are verified through objective testing methods rather than expert consensus on images or case outcomes.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. Adjudication methods like "2+1" typically refer to the process of resolving discrepancies in expert interpretations (e.g., in reading medical images). Since no expert interpretations are involved in establishing the "ground truth" for these engineering and biological tests, no such adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is relevant for assessing the clinical utility or diagnostic effectiveness of devices, often involving human readers interpreting medical data. This syringe device is a non-active, sterile, single-use product, and its evaluation focuses on its physical and biological integrity, not its interaction with clinical interpretation.

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

Not applicable. This device is a physical medical product (angiographic syringe), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily based on compliance with recognized national and international consensus standards for medical device physical performance, sterility, and biocompatibility. This involves objective measurements against predefined thresholds and specifications outlined in standards like ISO 7886, ISO 10993, ASTM F88, etc.

8. The Sample Size for the Training Set:

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device, not an AI/ML product. The manufacturer did not develop this device using machine learning.

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

The concept of a training set and its ground truth is not applicable for this device submission.

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