(66 days)
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Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Bayer ADVIA® 1650 System's Cholinesterase method:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA 1650) |
|---|---|---|
| Imprecision | ||
| Level 1 CV (U/L) | Predicate: 4.3% (at 4350 U/L) | 1.1% (at 4235.86 U/L) |
| Level 2 CV (U/L) | Predicate: 4.0% (at 6310 U/L) | 0.9% (at 6978.97 U/L) |
| Level 3 CV (U/L) | Not available for predicate | 1.1% (at 12318.49 U/L) |
| Correlation | ||
| Serum (r) | Implied high correlation (predicate K913198, K912217) | 0.994 (Y=1.325X+228.69) |
| Plasma vs Serum (r) | Implied high correlation | 0.984 (Y=0.973X+130.33) |
| Interference | Implied minimal interference | |
| Bilirubin (unconjugated, 25 mg/dL) | Implied acceptable % change | -0.70% |
| Bilirubin (conjugated, 25 mg/dL) | Implied acceptable % change | +0.95% |
| Hemoglobin (520 mg/dL) | Implied acceptable % change | +0.44% |
| Lipids (Intralipid, 520 mg/dL) | Implied acceptable % change | -0.13% |
| Analytical Range | Implied similar to predicate | 1,500 - 30,000 U/L |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for each metric. Instead, the demonstration of "substantial equivalence" to the predicate device (Kodak Vitros 250/ Cholinesterase) implies that the performance of the new device (ADVIA 1650 Cholinesterase) should be comparable to or better than the predicate. For imprecision, the ADVIA 1650 clearly shows lower CVs, indicating better precision than the predicate. For correlation and interference, the results are presented as positive data points supporting equivalence.
2. Sample Sizes Used for the Test Set and Data Provenance
- Imprecision: Not explicitly stated as "test set," but the data suggests it's from a study.
- Three levels were tested for the ADVIA 1650 Cholinesterase. The sample size for each level to calculate the CV is not specified (e.g., number of replicates).
- Two levels were reported for the Kodak Vitros 250 Cholinesterase. The sample size for each level to calculate the CV is not specified.
- Correlation:
- Serum: N = 58
- Plasma vs Serum: N = 40
- Interfering Substances: Not explicitly stated as "test set," but for each interfering substance, "control" and "test sample" values are provided, implying at least two measurements for each. The overall number of samples (e.g., healthy or spiked) for this study is not detailed.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in vitro diagnostic device for human serum/plasma, the samples would be human biological specimens. The study was conducted by Bayer Diagnostics, a multinational company.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in vitro diagnostic tests like Cholinesterase, the "ground truth" is typically established by the reference method or comparison method itself, rather than expert interpretation of results. The Cholinesterase activity is a measurable analyte, and the focus is on the accuracy, precision, and correlation of the new device's measurement against a validated comparator, not subjective expert assessment.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of medical images or clinical outcomes where there might be disagreement among reviewers, requiring a consensus or tie-breaker. For an in vitro diagnostic test measuring a specific analyte concentration, the "ground truth" or reference is the quantitative value from a comparison system.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostics that depend on human interpretation, where the goal is to assess how a device (often AI-assisted) impacts the diagnostic performance of multiple readers across various cases. The Cholinesterase assay is a quantitative laboratory test, not an imaging or interpretive diagnostic.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, this entire study represents a standalone (algorithm only) performance assessment. The ADVIA 1650 Cholinesterase system is an automated in vitro diagnostic device. The performance metrics (imprecision, correlation, interference, analytical range) presented are the direct output and performance characteristics of the instrument and its associated reagents, without human interpretive involvement in the measurement itself. The "algorithm" here refers to the chemical reactions and photometric measurements performed by the ADVIA 1650 system.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation was the comparison to a legally marketed predicate device/method: the Kodak Vitros 250/ Cholinesterase.
- For correlation studies, the measurements obtained from the Kodak Vitros 250 were effectively treated as the reference or "ground truth" against which the ADVIA 1650 results were compared.
- For imprecision, the inherent variability of the predicate served as a benchmark for what's acceptable.
- For interference, the "control" sample (without interferent) served as the baseline to assess the effect of the interfering substance.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" for the ADVIA 1650 Cholinesterase method. This is understandable because the device is a chemical assay system, not an AI/ML algorithm that typically requires a distinct training phase on data.
If there were any internal development or optimization studies done during the method's development by Bayer, those would have used various samples, but they are not detailed in this 510(k) summary, which focuses on validation data against a predicate.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the context of AI/ML is not discussed, the method for establishing "ground truth" for a training set is not applicable and not provided. The development of the Cholinesterase reagent and instrument parameters would be based on established biochemical principles and extensive internal R&D, rather than a data-driven training process with externally established ground truth labels common in AI/ML.
§ 862.3240 Cholinesterase test system.
(a)
Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.