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The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.

Note: The provided text describes a submission for a chemical assay (Cholinesterase Liquid), not an AI-powered device or an image-based diagnostic. Therefore, many of the requested criteria related to AI, ground truth, expert review, MRMC studies, and training/test sets are not applicable to this type of submission and are not mentioned in the documentation. The description focuses on demonstrating substantial equivalence of a modified in-vitro diagnostic assay to a previously cleared one.

Acceptance Criteria and Device Performance

The acceptance criteria for this device revolve around demonstrating substantial equivalence to a predicate device for its intended use and performance characteristics, specifically after adapting it to new analyzer systems.

Due to the nature of this submission (modification of an IVD assay to run on different analyzers), the acceptance criteria are implicitly met when the comparative performance studies show acceptable correlation.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study was a comparative performance study aimed at demonstrating the substantial equivalence of the modified Sentinel Cholinesterase Liquid assay when run on the Abbott AEROSET® and ARCHITECT® c8000® Analyzers, compared to the previously cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the comparative performance studies (method comparison studies). It states "comparative performance studies were conducted" but does not detail the number of samples or patients included. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is not applicable as the device is an in-vitro diagnostic assay for quantitative determination of cholinesterase, not an AI or image-based diagnostic requiring expert interpretation for ground truth. The "ground truth" for method comparison in an IVD context is typically the results obtained from a reference method or a legally marketed predicate device.

4. Adjudication Method:
This is not applicable for the reasons stated above. There is no expert adjudication process described for the performance of a quantitative chemical assay.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. This is definitively not applicable as this device is a laboratory assay, not an AI or imaging device involving human readers.

6. If a standalone (algorithm only without human-in-the loop performance) was done:
The device itself is standalone in the sense that it is a quantitative assay performed by an analyzer. Its performance is evaluated intrinsically through comparison to a predicate, not in interaction with a human "in the loop" in a diagnostic workflow like an AI algorithm might be. So, yes, the performance assessed is of the assay independent of immediate human interpretative input in a diagnostic decision-making context.

7. The Type of Ground Truth Used:
For the comparative performance studies, the "ground truth" was established by the results obtained from the legally marketed predicate device, Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717, and also by the AEROSET system's results being used as a comparator for the ARCHITECT c8000 system. This is a common approach for demonstrating substantial equivalence of IVD modifications.

8. The Sample Size for the Training Set:
Not applicable. This device is a chemical assay, not a machine learning algorithm that requires a "training set." The development of the assay itself would have involved method optimization and validation, but not in the context of a "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.

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