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510(k) Data Aggregation
(42 days)
MODIFICATION TO ALKP
The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Alkaline Phosphatase is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.
The provided text describes specific performance characteristics of the AlkP (Alkaline Phosphatase) assay, focusing on its substantial equivalence to a previously cleared device. Here's a breakdown of the acceptance criteria and study details based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison (AEROSET vs. Hitachi 717) | Acceptable correlation with Roche Alkaline Phosphatase assay on Hitachi 717 | Pooled data: Correlation coefficient = 0.999, Slope = 1.06, Y-intercept = -0.12 U/L |
| Method Comparison (ARCHITECT c8000 vs. AEROSET) | Acceptable correlation with AEROSET System | ARCHITECT c8000 Systems (3): Correlation coefficients = 1.000, 1.000, 1.000; Slopes = 0.99, 0.99, 0.98; Y-intercepts = -2.89, -1.67, 1.21 U/L respectively |
| Precision (Original vs. Modified Parameters) | Equivalent precision performance between original and modified parameters (p-values > 0.05 from F-test) | F-test yielding p-values > 0.05, demonstrating equivalent precision |
| Precision (AEROSET - 20 day studies) | Not explicitly stated, but established by equivalent performance to original, previously cleared assay. | Level 1 Total %CV: 3.2%; Level II Total %CV: 2.5% |
| Precision (ARCHITECT c8000 - 20 day studies) | Not explicitly stated, but established by equivalent performance to original, previously cleared assay. | Level I Total %CV: 4.1% to 5.7%; Level II Total %CV: 1.9% to 2.2% |
| Linearity | Not explicitly stated, but assumed to be within clinically acceptable ranges. | Linear up to 4,555 U/L |
| Limit of Quantitation (Sensitivity) | Not explicitly stated, but assumed to meet clinical needs. | 4.6 U/L |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For the AEROSET system method comparison with Hitachi 717: 40 samples were run on each of the three AEROSET systems, for a total of 120 samples.
- For the ARCHITECT c8000 system method comparison with AEROSET system: The number of samples is not explicitly stated in the provided text, only that three ARCHITECT c8000 Systems were used. (It's possible it was also 40 samples per system, but not specified).
- For 20-day precision studies: The number of samples for each level of control material is not specified, only that "two levels of control material" were used.
- For 5-day precision studies: The number of samples for each control material level with original and modified parameters is not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study seems to be conducted by the manufacturer, Abbott Laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study involves an in vitro diagnostic assay for quantitative determination of a biomarker (alkaline phosphatase). The "ground truth" or reference is established by established, cleared predicate devices (Roche Alkaline Phosphatase assay on Hitachi 717 Analyzer and the AEROSET System itself), not by human expert consensus or interpretation of images.
4. Adjudication method for the test set
Not applicable. As noted above, this study does not involve human interpretation or subjective assessment that would require an adjudication method. The comparisons are quantitative measurements against predicate devices.
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 an in vitro diagnostic device study, not an AI-assisted diagnostic imaging or human-in-the-loop study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the modified AlkP assay. The results (correlation, slope, intercept, precision, linearity, limit of quantitation) directly reflect the analytical performance of the device itself.
7. The type of ground truth used
The "ground truth" in this context is the quantitative measurement obtained from legally marketed predicate devices. Specifically:
- For the AEROSET system, the predicate was the Roche Alkaline Phosphatase assay on the Hitachi 717 Analyzer.
- For the ARCHITECT c8000 System, the predicate was the AEROSET System (which itself was compared to the Hitachi 717).
8. The sample size for the training set
Not applicable. This is a traditional in vitro diagnostic assay with modifications to existing parameters, not a machine learning model that requires a "training set" in the conventional sense. The "training" here would be the development and optimization process by R&D engineers, not a data-driven model training.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The development and optimization of such assays typically rely on extensive chemical and biological experimentation, calibration using reference materials, and iterative improvements to assay formulation and parameters, rather than a labeled training dataset.
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