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The proposed and the predicate device are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.

The Paramax® Ammonia and Ammonia Blank Reagent and DuPont aca Ammonia and Ammonia Blank Reagent are GLDH enzymatic method.

This 510(k) summary describes a device for in vitro diagnostic use, specifically a reagent for measuring ammonia levels. The information provided is very limited, focusing primarily on a comparison study for substantial equivalence rather than a detailed performance study with explicit acceptance criteria for diagnostic accuracy.

Here's an attempt to extract and infer information based on the provided text, while acknowledging its limitations:

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

Explanation of Implied Criteria: For in vitro diagnostic devices seeking 510(k) clearance, a common approach to demonstrating substantial equivalence is to show that the new device's measurements correlate strongly with a legally marketed predicate device. While explicit "acceptance criteria" are not stated, the high correlation coefficient (0.986) and the regression equation (slope of 0.980, intercept of -8.8) are presented as evidence of equivalence. A correlation coefficient of 0.986 is generally considered very strong in clinical chemistry, and a slope close to 1 with a small intercept suggests good agreement.

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

• Sample size used for the test set: 197 samples
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not applicable. This study compares the new device's measurements to an existing predicate device, not to an expert-established ground truth for diagnostic accuracy (e.g., disease presence). The "ground truth" in this context is the measurement obtained by the predicate device.

4. Adjudication method for the test set

• Not applicable. This was a direct comparison of quantitative measurements from two devices, not a process of adjudicating subjective interpretations.

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 in vitro diagnostic reagent, not an AI-powered image analysis tool or a device intended for direct interpretation by human readers in a diagnostic capacity that would involve MRMC studies.

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

• Yes, implicitly. The performance described is for the device (reagent) and its associated analyzer (Paramax® system) in producing a quantitative ammonia value. There is no human interaction described that modifies or influences the final numerical result provided by the system.

7. The type of ground truth used

• Comparative measurement to a predicate device: The "ground truth" for this study was the measurement generated by the DuPont aca Ammonia and Ammonia Blank Reagent system (the predicate device). This is a common approach for demonstrating substantial equivalence for IVD devices aiming for 510(k) clearance.

8. The sample size for the training set

• Not applicable. This submission describes a correlation study comparing a new reagent to a predicate; it does not explicitly mention "training" of an algorithm. The reagents themselves are chemical formulations, not algorithms that require training data.

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

• Not applicable for the same reasons as #8.

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