(8 days)
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurement of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the conjugated bilirubin is oxidized to biliverdin. The resulting decrease in absorbance at 444 nm is directly proportional to the concentration of total bilirubin.
The provided 510(k) summary describes the Abbott Laboratories TBil (Total Bilirubin) assay, an in vitro diagnostic device for the quantitative determination of total bilirubin in human serum or plasma.
This submission is a traditional 510(k) for a new device, not an AI/ML powered device. The document explicitly states that the device is an in vitro diagnostic assay and describes its chemical principle (oxidation of conjugated bilirubin to biliverdin). Therefore, many of the questions regarding AI/ML device validation (e.g., sample sizes for test/training sets, number of experts, adjudication methods) are not applicable.
Here's an analysis of the provided information, focusing on the relevant acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Performance of TBil Assay | Predicate Device (Johnson & Johnson Vitros™ Total Bilirubin) Performance |
|---|---|---|---|
| Method Comparison | Correlation Coefficient | 0.994 | N/A (implied benchmark for correlation) |
| Slope | 1.055 | N/A (implied benchmark for slope = 1) | |
| Y-intercept | 0.009 mg/dL | N/A (implied benchmark for Y-intercept = 0) | |
| Precision | Total %CV (Level 1/Panel 101) | 5.6% | N/A (stated as "similar Performance Characteristics" for both) |
| Total %CV (Level 2/Panel 102) | 4.3% | N/A | |
| Linearity | Upper Limit | Up to 23.38 mg/dL | N/A (difference between assay ranges noted, but specific predicate range not given) |
| Sensitivity | Limit of Quantitation | 0.13 mg/dL | N/A |
Study Proving Device Meets Acceptance Criteria:
A "comparative performance study" was conducted using the Abbott AEROSET™ System. This study compared the performance of the Abbott TBil assay with the predicate device, the Total Bilirubin on the Johnson & Johnson Vitros™ System. The results, as presented in the table above, demonstrated "acceptable correlation" and other performance characteristics, leading to the conclusion of "substantial equivalence."
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the comparative performance studies (method comparison or precision studies).
- Data Provenance: The document does not specify the country of origin of the data. It implies the studies were conducted by Abbott Laboratories. The studies appear to be prospective in nature, as they involve actively "conducting" comparative performance studies and precision studies for the new device.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This is an in vitro diagnostic assay based on a chemical reaction, not an AI/ML device relying on expert image or data interpretation. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation is not applicable. The "ground truth" for method comparison would be the results obtained from the predicate device (Johnson & Johnson Vitros™ System), which is also a quantitative measurement system.
4. Adjudication Method for the Test Set
As this is a quantitative chemical assay and not an AI/ML device with subjective interpretations, adjudication methods are not applicable. The comparison is based on numerical agreement between the new device and the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers in interpreting complex data (e.g., medical images). The Abbott TBil assay is an automated in vitro diagnostic assay that provides a quantitative measurement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device is an automated in vitro diagnostic assay. Its performance, as described by linearity, sensitivity, and precision, represents its standalone performance without human interpretation in the loop beyond operating the instrument and collecting the sample. The "method comparison" also evaluates its standalone performance against another standalone device.
7. The Type of Ground Truth Used
The "ground truth" for the method comparison was the quantitative measurements obtained from the legally marketed predicate device (Johnson & Johnson Vitros™ System for Total Bilirubin). For precision, the ground truth refers to the intrinsic variability of the assay itself, demonstrating reproducibility around a given (control) concentration.
8. The Sample Size for the Training Set
This is an in vitro diagnostic assay that performs a chemical reaction, not an AI/ML device that requires a training set. Therefore, the concept of a "training set" in the context of machine learning is not applicable.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.