(126 days)
The IMMAGE Immunochemistry System Apoliooprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.
The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE Immunochemistry System. They are intended for use in the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples.
The provided document describes the safety and effectiveness of the IMMAGE Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents. The study is a comparison to predicate devices, focusing on method comparison, stability, and imprecision.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for each performance metric, but the "Summary of Performance Data" section implies that the presented results demonstrate substantial equivalence to the predicate devices. For a more formal acceptance criteria, one would typically expect predefined thresholds for slope, intercept, r-value, and imprecision (%CV). However, for the purpose of this analysis, we will interpret "device performance" as the reported results, benchmarked against the predicate devices.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (IMMAGE APA Reagent) | Reported Device Performance (IMMAGE APB Reagent) |
|---|---|---|---|
| Method Comparison | |||
| Slope | Close to 1 (indicating proportional agreement) | 0.998 | 1.030 |
| Intercept | Close to 0 (indicating no constant bias) | 1.86 | -1.34 |
| Correlation (r) | High (indicating strong linear relationship) | 0.983 | 0.991 |
| Stability | |||
| Shelf-life | 24 months (consistent with predicate performance) | 24 months | 24 months |
| On-board/Open Container Stability | 14 days (consistent with predicate performance) | 14-day on board | 14 open container stability |
| Calibration Stability | 14 days (consistent with predicate performance) | 14 day calibration stability | 14 day calibration stability |
| Imprecision | |||
| Within-run %CV (Level 1) | Low %CV (indicating good reproducibility) | 5.5 | 3.2 |
| Within-run %CV (Level 2) | Low %CV | 3.2 | 2.5 |
| Within-run %CV (Level 3) | Low %CV | 2.9 | 2.5 |
Note: The "Acceptance Criteria" column above is inferred based on the goal of showing "substantial equivalence" to existing commercial distribution devices. For a regulatory submission, explicit numerical thresholds would typically be defined beforehand.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states the "Number of Results" for the imprecision study as 80 for each level (Level 1, Level 2, Level 3) for both APA and APB reagents. This sums to 240 measurements for APA and 240 for APB, totaling 480 individual results for the imprecision study. The sample size for the method comparison study (which produces the slope, intercept, and r-value) is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is implied to be a prospective study conducted by Beckman Instruments, Inc. for the purpose of demonstrating device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a diagnostic reagent and system for quantitative determination of apolipoproteins, not an imaging device or a diagnostic algorithm requiring human expert interpretation. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the conventional sense (e.g., radiologists interpreting images) does not directly apply here.
- Ground Truth Establishment: For in vitro diagnostic devices like this, "ground truth" is typically established by comparing the new device's results against a well-characterized and often established reference method (the predicate device in this case) or gravimetrically prepared standards for imprecision and linearity studies. The "experts" would be the laboratory personnel performing the experiments and verifying instrument calibration and control material concentrations. Their qualifications would typically involve appropriate clinical laboratory training and experience.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., image reading) where disagreement among experts needs resolution. This concept does not apply to the quantitative measurement of apolipoproteins by an immunochemistry system. The results are numerical values, and any discrepancies would be investigated through quality control, calibration checks, or re-testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for assessing the impact of a new diagnostic tool on human reader performance, particularly in fields like radiology where subjective interpretation is key. This document describes a quantitative in vitro diagnostic device, where the comparison is system-to-system, not human-reader-to-human-reader or human-reader-with-AI vs. human-reader-without-AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (method comparison, stability, imprecision) represent standalone performance of the IMMAGE™ Immunochemistry System and its reagents. These studies evaluate the analytical performance of the device itself, providing quantitative results without direct human intervention in the result generation process (beyond initiating tests and quality control). The "human-in-the-loop" aspect for such a device would be a laboratory technician operating the instrument and interpreting the numerical output, but the performance data here is about the device's accuracy and precision in generating those numbers.
7. The Type of Ground Truth Used
For the method comparison study, the "ground truth" was essentially the measurements obtained from the predicate devices (Beckman Apolipoprotein A-1 Reagent on the ARRAY and Beckman Apolipoprotein B Reagent on the ARRAY). The study aimed to demonstrate substantial equivalence by showing a strong correlation and agreement between the new IMMAGE system and the established predicate.
For the imprecision study, the "ground truth" for the mean concentration values would be based on assigned values of control materials (e.g., derived from manufacturers' assays or reference methods), with the goal of demonstrating consistent and reproducible measurements around those values.
8. The Sample Size for the Training Set
The document does not describe the development of an algorithm or AI model that would require a "training set." This device is an immunochemistry system with specific reagents, not a machine learning or AI-based diagnostic tool. Therefore, the concept of a "training set" in this context is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there is no "training set" for this type of device. The ground truth for validating the analytical performance involves comparison against established predicate methods and control materials with known values, as detailed in point 7.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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 § 862.9.