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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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The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.

The Ecomed Disposable Angiographic Syringes are disposable syringes for use with contrast delivery systems that deliver contrast media or saline into the vascular system for the purpose of obtaining enhanced diagnostic images. The syringes are available in several sizes and configurations to ensure compatibility with US legally marketed contrast delivery systems.

The syringes are provided in kits that are configured from the following list of components:

• . Syringe(s)
• . Fill tube
• Vial Spike (small/large)
• . Transfer tubing set (length, y vs straight)

I will provide an answer assuming the request relates to the 'Ecomed Disposable Angiographic Syringes' as described in the provided text.

Based on the provided text, the device in question is the "Ecomed Disposable Angiographic Syringes," which are mechanical devices for injecting contrast media and saline. The text describes non-clinical performance (bench) tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets a specific clinical acceptance criterion with statistical performance metrics. Therefore, many of the requested fields related to diagnostic performance or human reader studies are not applicable.

Here's the information extracted from the document:

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

The document does not explicitly present a table of "acceptance criteria" with numerically reported "device performance" in the context of diagnostic accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicit in the compliance with various ISO and ASTM standards, which cover aspects like sterility, biocompatibility, packaging, and physical performance. The "reported device performance" is a general statement that the device fulfills these standards and is substantially equivalent.

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

The document does not specify the sample size for each individual test mentioned (e.g., how many syringes were subjected to leak testing). It only states that "Non-clinical performance (bench) tests conducted on the subject devices to support substantial equivalence includes comparison testing and physical performance testing." The data provenance is laboratory bench testing, not patient data, so country of origin or retrospective/prospective status is not applicable in the typical sense.

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

Not applicable. This is a bench study for substantial equivalence of a medical device (angiographic syringes), not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method for the test set

Not applicable, as it is a bench testing study, not a study requiring expert adjudication of results.

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 disposable angiographic syringe, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a disposable angiographic syringe, not an algorithm.

7. The type of ground truth used

For dimensional compatibility and physical performance tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate/reference devices, as well as the requirements set by the various ISO and ASTM standards. For biocompatibility and sterility tests, the "ground truth" would be the chemical, biological, and physical parameters defined by the relevant standards (e.g., absence of cytotoxicity, pyrogens, harmful reactions).

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model.

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

Not applicable. This is a medical device, not an AI model.

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The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Arterion Mark 7 is a software controlled medical device used to inject contrast agents from a 150ml disposable syringe. Commonly referred to as a powered injector it is designed to allow a user to fill a disposable syringe, and perform an injection with a preprogrammed volume and flow rate. The Arterion consists of three basic components or modules: a Power Unit, Display Control Unit (DCU), and an injector head.

This submission describes a medical device, the MEDRAD Mark 7 Arterion Injection System, which is a powered injector for contrast media. The provided document is a 510(k) summary and related FDA correspondence, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a primary clinical trial or performance study report.

Based on the provided text, the device is an injection system, not an AI-powered diagnostic device, therefore, many of the requested categories related to AI performance metrics, ground truth, and expert evaluation are not directly applicable.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding performance results. Instead, it lists various types of performance data bench and laboratory testing that were performed to support substantial equivalence. The "performance" in this context refers to the device's operational characteristics and safety, not diagnostic accuracy.

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

Given that this is a hardware device (injector) with software control, the "test set" does not refer to a set of medical images or patient data in the way it would for an AI diagnostic device. Instead, "testing" refers to various engineering and biocompatibility tests.

• The document does not specify sample sizes for any of the listed tests (e.g., how many disposable units were tested for biocompatibility, how many injection cycles were performed for fluid delivery testing, etc.).
• Data Provenance: The nature of these tests means they are typically performed in a controlled laboratory setting (bench testing) by the manufacturer. The document does not specify country of origin for the data or whether the tests were retrospective or prospective; these terms are less applicable to engineering verification and validation testing.

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

This question is not applicable. The device is not an AI diagnostic tool and does not generate "ground truth" through expert interpretation. The "ground truth" for its performance would be engineering specifications, established safety standards (like ISO 10993 for biocompatibility), and regulatory requirements.

4. Adjudication Method for the Test Set

This question is not applicable. There is no expert adjudication process for assessing the performance of this type of medical device in the context of this 510(k) summary. Performance is assessed against engineering specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. An MRMC study is relevant for AI diagnostic algorithms where human readers' performance is compared with and without AI assistance on a set of medical cases. This device is an injector, not a diagnostic imaging interpretation tool.

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

This question is not applicable. While the device has software, it is part of a complete injection system that requires human operation. "Standalone" performance in the AI context refers to an algorithm's diagnostic accuracy without human intervention, which is not relevant here. The software verification/validation ensures the software components function as designed within the system.

7. The Type of Ground Truth Used

For an injection system, "ground truth" refers to the established engineering specifications and safety standards that the device must meet.

• Engineering Specifications: E.g., precise fluid volume delivery, flow rate accuracy, pressure limits, mechanical durability, electrical safety parameters.
• Safety Standards: Such as those for biocompatibility (ISO 10993 series for disposables), electrical safety, and electromagnetic compatibility.
• The results of internal bench and laboratory testing are compared against these predetermined specifications and standards.

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI/ML model that learns from a "training set" of data. Its functionality is based on predefined programming and mechanical/electrical design, not on learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as #8. There is no training set or associated ground truth for a device of this nature.

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