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The AMON method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista™ System.

The Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge is an in vitro device intended to measure ammonia levels in plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Ammonia (AMON) Flex® reagent cartridge (K863840), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Ammonia (AMON) Flex® reagent cartridges are the same as those contained in the Ammonia (AMON) Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the device, nor does it alter the fundamental scientific technology of the device.

The provided text is a 510(k) summary for a medical device (Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device.

Therefore, much of the requested information cannot be found in the provided text. The document is about a packaging change for an already cleared device, allowing it to be used on a new instrument system. The "study" mentioned is comparative testing to demonstrate substantially equivalent performance to the predicate device.

However, I can extract what is available:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as it's a submission for a packaging change and not a new diagnostic algorithm. The primary "criterion" for this submission is substantial equivalence to the predicate device.

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

• Sample size: Not specified in the provided text. The document mentions "comparative testing described in the protocol included in this submission," but the protocol details (including sample size) are not part of this summary.
• Data provenance: Not specified (e.g., country of origin of data, retrospective or prospective).

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

This information is not applicable and not provided in the context of this 510(k) submission. This submission is for an in vitro diagnostic device (a reagent cartridge), whose "ground truth" would typically refer to the accuracy of its measurement capability against known standards or reference methods. The evaluation here is for chemical measurement performance, not expert-interpreted images or clinical decisions.

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

This information is not applicable and not provided. Adjudication methods like 2+1 are typically used for expert consensus in image interpretation or clinical outcomes, which is not the nature of this device's evaluation.

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 as the device is an in vitro diagnostic reagent cartridge for chemical analysis, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device itself is the "algorithm" (the chemical assay). The performance is inherent to the assay and the instrument system it runs on. The "standalone" performance is its ability to accurately measure ammonia levels. The document states "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance" regarding this, but the specific performance metrics (e.g., accuracy, precision) are not detailed in the summary.

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

The "ground truth" for an in vitro diagnostic for ammonia levels would typically be:

• Reference methods for ammonia measurement.
• Known concentration standards.
• Correlation with clinically relevant ammonia levels in patient samples, often compared to an existing, cleared diagnostic device (the predicate).

While not explicitly stated as "ground truth," the comparison to the Dimension® AMON Flex® reagent cartridge (K863840) serves as the primary reference point (predicate device) for establishing equivalent performance.

8. The sample size for the training set:

This is not applicable as this is not an AI/machine learning device with a training set.

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

This is not applicable as this is not an AI/machine learning device with a training set.

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