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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 Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit (K943189). The Medrad Disposable MRI Kit with Check valve has the same intended use as the predicate device - to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates in an MR application. The kit may consist of one or all of the following:

• 2- 65 ml syringes (K935668)
• 96" Low Pressure Connector Tube/T-connector assembly (K943189) .
• . Fluid Delivery Device (Spike) - (K810624)
• Normally closed check-valve B. Braun/Burron (K790062) ●
• Female/Female Luer Adapter B.Braun/Burron (K942391) .
  The only difference between this kit and the predicate device is that this kit contains a normally closed check valve and a female/female luer Adapter. Device Verification and Validation Testing has been performed.
  The normally closed check-valve is a attached to the 96" LLPCT at the Tconnector (K943189) and is used to restrict flow in one of two directions. The device is normally closed requiring a minimum amount of force to open. The check-valve attaches to the 'A' syringe and remains closed during saline flush from the 'B' syringe to prevent contrast trickle during this process.
  The Female/Female Luer Adapter is a disposable device used to provide a fluid path between two vessels with male luer terminations. This device can be compared to the Medrad Ouick Fill Tube (K800823) which is also a filling device.
  All other components of the kit are identical to those in K943189.
  The devices are sterilized using Ethylene Oxide gas. Validation is performed according to AAMI guidelines.

Here's an analysis of the provided text regarding the Medrad Disposable MRI Kit with Check Valve, focusing on acceptance criteria and the supporting study information:

It's important to note that this document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, the level of detail regarding comprehensive studies and acceptance criteria is different from what might be found in a full efficacy study report for a new drug or high-risk medical device. The focus here is on demonstrating that the new device does not raise new issues of safety or effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly present acceptance criteria in a quantitative, pass/fail table format, nor does it detail a standalone study proving the device meets specific performance metrics with numerical results for each criterion regarding its primary function (fluid delivery). Instead, it demonstrates substantial equivalence by comparing features and performing validation tests related to manufacturing and safety attributes.

However, we can infer some "acceptance criteria" based on the validation tests performed and the comparison to the predicate devices. The "reported device performance" is primarily stated as compliance with established standards and equivalence to the predicate.

• Predicate Device Characteristics: The existing Medrad Qwik-Fit MRI Disposables Kit (K943189) and its components serve as a ground truth for substantial equivalence, specifically for features that are identical or closely matched.
• Functional Specifications: The intended behavior of the check-valve (restricting flow, preventing trickle) and the luer adapter (fluid transfer) define the functional "ground truth" against which device performance is validated internally.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product.

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

This is not applicable for the same reason as point 8.

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