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510(k) Data Aggregation
(44 days)
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 serum 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 405 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AlkP (Alkaline Phosphatase) device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the "Performance Characteristics" section, we can infer the criteria used for substantial equivalence. The primary criterion is strong correlation and similar clinical results to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Acceptable correlation with predicate device | Correlation coefficient = 0.9981 |
| Slope of method comparison close to 1 | Slope = 1.167 |
| Y-intercept of method comparison close to 0 | Y-intercept = -2.324 U/L |
| Acceptable precision (within-run, between-run, between-day) | Total %CV for Level 1/Panel 111 = 3.8% |
| Total %CV for Level 2/Panel 112 = 2.6% | |
| Linear up to a predefined maximum concentration | Linear up to 2,000 U/L |
| Acceptable sensitivity | Sensitivity = 6 U/L |
| Overall Goal: Substantially equivalent to predicate device | "The Alkaline Phosphatase assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay as demonstrated by results obtained in the studies." |
| "Both assays yield similar clinical results." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the "comparative performance studies" or "precision studies." It only refers to "two levels of control material" for precision.
The data provenance is not specified regarding country of origin. The studies appear to be retrospective in the sense that they are conducted on samples and controls to characterize the device's performance, rather than on new patient cohorts specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes an in vitro diagnostic assay, which measures a biochemical marker (alkaline phosphatase) in human serum or plasma. It does not involve human interpretation of images or other subjective data that would require a ground truth established by experts. The "ground truth" for this type of device is the actual concentration of the analyte, which is measured using a reference method or validated control materials.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device, as there is no subjective interpretation requiring adjudication among experts.
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 assay, not an AI-powered image analysis or diagnostic support tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are for the standalone performance of the AlkP assay (the device itself, which is a chemical assay run on an automated analyzer). The "algorithm" here is the chemical reaction and photometric measurement process. The "without human-in-the-loop" refers to the assay's direct measurement capability.
7. The Type of Ground Truth Used
For method comparison, the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay served as the reference standard or "ground truth" for relative performance. For precision studies, control materials with known (or established) values were used. The document implies that these control materials represented different levels of alkaline phosphatase.
8. The Sample Size for the Training Set
Not explicitly stated. For an in vitro diagnostic assay, there isn't typically a "training set" in the machine learning sense. The assay's parameters (reagent concentrations, incubation times, measurement wavelengths) are developed and optimized through R&D without a distinct "training set" as understood in AI/ML. The provided data focuses on validation (test set performance).
9. How the Ground Truth for the Training Set Was Established
Not applicable in the machine learning sense. The "ground truth" for developing and optimizing an in vitro diagnostic assay would be based on established biochemical principles, extensive laboratory testing, calibration against reference methods/materials, and analytical validation during the assay development process to ensure it accurately measures the analyte.
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