(132 days)
Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. The test methodology is a colorimetric method based on that described by Jendrassik and Grof (1938). Total bilirubin is determined in the presence of caffeine, which releases albumin bound bilirubin, by the reaction with diazotized sulphanilic acid.
This document describes the performance testing of the Poly-Chem 90 Total Bilirubin device, a reagent/test system for quantitative in vitro measurement of total bilirubin in human serum.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (from context, implicit) | Reported Device Performance (Poly-Chem 90 Total Bilirubin) |
|---|---|---|
| Precision (Intraassay %CV) | Lower is better (compared to predicate) | 0.23% to 1.65% (samples from 0.50 to 25.71 mg/dL) |
| Precision (Interassay %CV) | Lower is better (compared to predicate) | 4.29% to 5.40% (samples from 0.50 to 25.71 mg/dL) |
| Measuring Range (Linearity) | Comparable or improved to predicate | 0.07 - 27.5 mg/dL |
| Sensitivity (Limit of Quantitation) | Lower is better (not explicitly stated, but generally desired) | 0.08 mg/dL (10% CV) |
| Interference (Hemoglobin) | Acceptable level (no significant interference) | 600 mg/dL (highest level tested with no interference) |
| Interference (Triglyceride) | Acceptable level (no significant interference) | 554 mg/dL (highest level tested with no interference) |
| Method Comparison (Slope vs. Predicate) | Close to 1.0 (indicating agreement) | 0.98 (95% CI: 0.98 to 0.99) |
| Method Comparison (Intercept vs. Predicate) | Close to 0.0 (indicating agreement) | -0.03 (95% CI: -0.04 to -0.01) |
| Method Comparison (Correlation Coefficient, r) | Close to 1.0 (indicating strong correlation) | 0.9998 |
Note on Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating "substantial equivalence" to the predicate device (Poly-Chem Total Bilirubin, K973995). Therefore, the reported device performance is compared to the predicate's performance to establish this equivalence. While specific numerical acceptance criteria are not explicitly listed as pass/fail thresholds, the statistical results (e.g., correlation coefficient, confidence intervals for slope and intercept) are used to support the claim of substantial equivalence.
2. Sample Sizes used for the test set and the data provenance:
- Precision: No explicit sample size is given for the precision runs beyond "Sample 1", "Sample 2", "Sample 3" across two instruments. Each "sample" likely represents multiple replicates over several days to determine within-run and between-run variability. The values presented are means, SDs, and CVs, implying multiple measurements. The origin is not specified, but it's likely from internal lab testing given the nature of a 510(k) submission for a diagnostic reagent.
- Linearity, Sensitivity, Interference: No specific sample sizes are given, but these are typically determined through laboratory experiments using controlled samples.
- Method Comparison: 82 samples were used for comparison with the predicate device.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission for an in vitro diagnostic, this data would be from controlled laboratory studies, likely using human serum samples. The country of origin is not specified, but the manufacturer is based in the United Kingdom. It is a prospective study as it involves new testing of the Poly-Chem 90 and comparison to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. This is an in vitro diagnostic (IVD) reagent for measuring a quantitative analyte (Total Bilirubin). The "ground truth" for method comparison and performance characteristics is established by a reference method or the predicate device itself, not by expert interpretation of images or clinical cases.
4. Adjudication method for the test set:
Not applicable. As an IVD for quantitative measurement, there is no need for expert adjudication. The comparison is against established laboratory methods or a predicate device.
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 is a chemical reagent and instrument system, not an AI-assisted diagnostic imaging tool that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. This device inherently operates in a "standalone" manner. The Poly-Chem 90 analyzer, using the Poly-Chem 90 Total Bilirubin reagent, provides a quantitative measurement directly. There isn't a "human-in-the-loop" interpretation step in the same way as with an imaging AI system. The performance characteristics (precision, linearity, sensitivity, comparison to predicate) are all measures of the algorithm/reagent's accuracy and reliability in providing the numerical result.
7. The type of ground truth used:
- Method Comparison: The "ground truth" for the method comparison study was established by the predicate device, Poly-Chem Total Bilirubin (K973995). The results from the new device (Poly-Chem 90) were compared to the results obtained from the predicate device on the same samples.
- Other performance metrics (Precision, Linearity, Sensitivity, Interference): These are inherent performance characteristics determined against established laboratory practices and analytical standards. For example, linearity is assessed by testing known concentrations, and sensitivity by calculating limits of detection/quantitation based on statistical methods from repeated measurements of low-concentration samples.
8. The sample size for the training set:
Not applicable. This device is a chemical reagent-based diagnostic system, not an AI/machine learning model that requires a "training set." The performance is characterized through traditional analytical validation methods.
9. How the ground truth for the training set was established:
Not applicable. As stated above, there is no "training set" for this type of device.
§ 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.