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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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This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or cather inserted into a vein. Additionally, this device is intended to serve as an injection site for other influsion fluids. This device is intended to be used only by trained professionals in a clinical or hospital environment.

The KippMed I.V. Manifold is substantially equivalent to the Braun Safesite Manifold, Minor differences in design specifications have been listed in Table One. Both devices are intended to provide connections to an I.V. Administration Set. Both devices provide a multi-port connector with a female leur-lock adapter, three normally closed backcheck valves and a connection adapter. The inlet connection adapter for both devices includes a free-spinsing hub/leur lock to connect to I.V. lines. Both devices are sterile and nonpyrogenic.

This document (K970255) describes an I.V. Manifold, a low-risk medical device. The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically associated with studies for higher-risk devices, particularly those involving AI/ML components or complex diagnostic functions with human interpretation.

For this I.V. Manifold, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device and confirming basic safety and performance requirements, not on diagnostic accuracy, reader performance, or AI efficacy.

Here's a breakdown based on the provided text, addressing your points where applicable, and explaining why others are not relevant for this type of submission:

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

For this device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device in terms of design, materials, intended use, and meeting basic safety standards (sterilization, biocompatibility). The "reported device performance" refers to the device meeting these equivalence points and safety validations.

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

This information is not applicable and not provided in the document. The "tests" for this device are primarily related to:

• Sterilization validation: This typically involves laboratory testing on a statistically significant sample of devices to demonstrate the Sterility Assurance Level (SAL). The specific sample size or provenance is not detailed in this summary but would be part of the full validation report.
• Biocompatibility testing: This involves in vitro and potentially in vivo tests on the raw materials and finished components. Specific sample sizes for these material tests are not in the summary.
• Bench testing for functional equivalence: This would confirm aspects like leak integrity, flow rates, and connection strength. The document mentions "minor differences in design specifications" and a comparison in "Table 1," implying such testing was done, but details are not provided. These are typically laboratory tests.

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. There is no concept of "ground truth" or "expert readers" in the context of an I.V. manifold submission. This device performs a mechanical function, not a diagnostic one requiring human interpretation of data.

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

Not applicable for the same reasons as point 3.

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 an I.V. manifold; it does not involve AI, human readers, or diagnostic interpretation.

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 (expert consensus, pathology, outcomes data, etc)

Not applicable. The "truth" for this device is its physical integrity, sterility, biocompatibility, and functional equivalence to its predicate. These are established through validated testing methodologies, not expert consensus on diagnostic findings or clinical outcomes data in the way you might see for an AI diagnostic device.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore has no "training set."

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

Not applicable for the same reasons as point 8.

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