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The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder.
The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.

Device Description

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AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Lithium method, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data rather than explicit pre-defined "acceptance criteria" in a go/no-go fashion. However, we can infer performance targets or expectations based on the predicate device's performance and the regression analysis.

Performance Metric	Acceptance Criteria (Inferred/Predicate)	Reported Device Performance (ADVIA IMS)
Imprecision (Total CV%)	Comparable to or better than predicate device (ThermoTrace)
- Level ~1.00 - 1.15 mmol/L	ThermoTrace: 3.9%	2.3%
- Level ~2.06 - 2.49 mmol/L	ThermoTrace: 3.6%	1.8%
Correlation (with CDC Flame)	Strong correlation (R close to 1, small Syx)	R = 0.997, Syx = 0.06 mmol/L
Correlation (with ThermoTrace)	Strong correlation (R close to 1, small Syx)	R = 0.997, Syx = 0.05 mmol/L
Interference (Bilirubin unconjugated)	Clinically insignificant effect	6% change at 30 mg/dL Bilirubin
Interference (Bilirubin conjugated)	Clinically insignificant effect	-2% change at 30 mg/dL Bilirubin
Interference (Hemoglobin)	Clinically insignificant effect	-2% change at 1000 mg/dL Hemoglobin
Interference (Lipids/Triglycerides)	Clinically insignificant effect	-9% change at 500 mg/dL Lipids
Analytical Range	Adequate for clinical use (e.g., matching predicate)	0.10 - 3.00 mmol/L

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Correlation Studies: 49 samples (N=49) for both the comparison with CDC Flame and ThermoTrace systems.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a 510(k) submission, which typically involves internal validation testing by the manufacturer. Assuming typical practices, the samples were likely collected prospectively for the purpose of the study, and the origin is probably related to the manufacturer's testing facilities (e.g., within the US or a region where Bayer operates).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

None applicable. This is an in vitro diagnostic device for measuring a chemical analyte (Lithium). "Ground truth" for clinical decisions or image interpretation by experts is not relevant here. The ground truth for the comparison studies is established by reference methods or predicate devices (CDC Flame, ThermoTrace).

4. Adjudication Method for the Test Set:

None applicable. As detailed in point 3, there are no "experts" in the sense of clinical decision-makers adjudicating results. The comparison methods act as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is not relevant for this type of in vitro diagnostic device, which directly measures a chemical concentration rather than assisting human readers in interpreting complex diagnostic information (like medical images).

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

Yes. The entire submission details the standalone performance of the ADVIA IMS Lithium method. The "device" is the algorithm/system for measuring lithium. There isn't a human-in-the-loop component in the measurement process itself, although a human interprets the numerical results for patient management. The data presented for imprecision, correlation, and interference are all standalone performance metrics.

7. The Type of Ground Truth Used:

Reference Method/Predicate Device Measurements:
- For the correlation study with "Comparison System (X) CDC Flame," the ground truth for lithium concentration was established by the Centers for Disease Control (CDC) Flame Photometer, which is a recognized reference method.
- For the correlation study with "Comparison System (X) ThermoTrace," the ground truth was established by the predicate device, the ThermoTrace Lithium method.
- For imprecision and interference studies, the ground truth is often established by precise gravimetric or volumetric preparation of known concentrations, confirmed by a reference method.

8. The Sample Size for the Training Set:

Not explicitly stated/not applicable in the same way as AI/ML. This device is a traditional immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the common sense for model development. The development process would involve method development, reagent formulation, and analytical validation rather than machine learning training.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As described above, this is a traditional in vitro diagnostic assay, not an AI/ML system requiring a training set with established ground truth labels for learning. The "ground truth" during development would be based on known chemical concentrations and performance against established analytical standards.

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