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510(k) Data Aggregation
(66 days)
Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.
Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.
The presented document is a 510(k) summary for the IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Calibrator, submitted by Beckman Coulter, Inc. It describes the device, its intended use, comparison to a predicate device, and a summary of performance data.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, r-value, or imprecision percentages. Instead, it presents the results of method comparison and imprecision studies as evidence of substantial equivalence to the predicate device. The implied acceptance is that the device's performance is comparable to or within expected variations for such assays, as demonstrated by the presented data.
| Study Type | Metric | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|---|
| Method Comparison | Slope | Close to 1.0 | 1.06 | Indicates good correlation between the IMMAGE system and the predicate Access Total IgE system. |
| Intercept | Close to 0 | 2.75 | A small intercept indicates minimal systematic bias. | |
| r (correlation coefficient) | High (e.g., >0.95) | 0.991 | Demonstrates strong linear correlation with the predicate method. | |
| n (sample size) | Adequacy for statistical significance | 125 | Generally considered a reasonable sample size for method comparison in diagnostic assays. | |
| Imprecision | %CV (Within-Run)Level 1 | Low (e.g., typically <10-15%) | 5.8% | Indicates good reproducibility within a single run at a low IgE concentration. |
| %CV (Within-Run)Level 2 | Low | 5.1% | Indicates good reproducibility within a single run at a medium IgE concentration. | |
| %CV (Within-Run)Level 3 | Low | 5.2% | Indicates good reproducibility within a single run at a high IgE concentration. | |
| %CV (Total)Level 1 | Low | 6.7% | Reflects overall reproducibility, including run-to-run variability, at a low IgE concentration. Typically slightly higher than within-run. | |
| %CV (Total)Level 2 | Low | 6.3% | Reflects overall reproducibility at a medium IgE concentration. | |
| %CV (Total)Level 3 | Low | 7.3% | Reflects overall reproducibility at a high IgE concentration. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: n = 125 samples.
- Imprecision: For each of the three levels tested, n = 80 measurements (implying multiple replicates across multiple runs). The term "N" is used for the number of measurements, not distinct patient samples.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the samples were retrospective or prospective. Given that it's a 510(k) submission to the FDA, it's highly probable the studies were conducted in the US or under comparable standards. "Serum or plasma" is mentioned for the intended use, indicating the biological sample type.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this device. The IMMAGE® Immunochemistry System is an in vitro diagnostic (IVD) device for quantitative determination of a biomarker (Total IgE). The "ground truth" for this kind of device is established by a reference method or through highly controlled, well-characterized samples, not by expert consensus or interpretation of images/clinical data. The predicate device (Access® Total IgE) serves as the reference for the method comparison, meaning its results are considered the "ground truth" for comparative purposes.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established by a quantitative reference method (the predicate device) or by direct measurement against known standards, not by human interpretation requiring adjudication.
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 devices where human interpretation plays a significant role (e.g., radiology AI tools). The IMMAGE System is an automated in vitro diagnostic device that produces quantitative results directly.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, the studies presented (method comparison and imprecision) represent standalone performance of the IMMAGE® Immunochemistry System. The device directly measures IgE levels in samples; there isn't a "human-in-the-loop" component in terms of result generation for these performance studies. The results are generated by the device itself.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation can be described as follows:
- For Method Comparison: The results obtained from the predicate device (Access® Total IgE) were used as the comparative "ground truth" or reference. The goal was to show concordance between the new device and the established, legally marketed predicate.
- For Imprecision: The "ground truth" refers to the expected concentration of IgE in the quality control samples or patient samples used for repeated measurements. These values are typically established through rigorous characterization or use of certified reference materials if available.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. For IVD devices like this one, "training set" doesn't typically apply in the same way it does for machine learning algorithms. The development of such a system involves extensive R&D, reagent formulation, and analytical validation. However, specific "training sets" in the AI sense are not usually disclosed or relevant for traditional IVD device submissions. The performance data presented (method comparison, imprecision, linearity, stability) are part of the analytical validation, not a "training" or "test" set in an AI context.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and its associated ground truth in the context of machine learning is generally not applicable to this type of traditional immunochemistry system. The "ground truth" during the development of such assays would involve highly characterized samples, reference materials, and established analytical chemistry principles to ensure the reagents and system accurately detect and quantify the analyte (IgE).
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