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510(k) Data Aggregation
(190 days)
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
The IMMAGE Immunochemistry System Complement C3 (C3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C3 by rate nephelometry.
The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C4 by rate nephelometry.
The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human complement C4 by rate nephelometry.
The IMMAGE Immunochemistry System C3 and C4 Reagents in conjunction with Beckman Calibrator 1, are intended for use in the quantitative determination of Complement C3 and Complement C4 concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.
This document describes the IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents. The information provided is for regulatory clearance (510(k) submission) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria for an entirely new technology. Therefore, the "acceptance criteria" here are implicitly tied to the performance of the predicate device and generally accepted laboratory performance standards for such assays.
Here's an analysis of the provided text in the requested format:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (C3) | Reported Device Performance (C4) |
|---|---|---|---|
| Method Comparison | Agreement with predicate method (e.g., strong correlation, slope ≈ 1, intercept ≈ 0) | Slope: 0.969, Intercept: 6.18, r: 0.994 (n=100) | Slope: 0.983, Intercept: -1.48, r: 0.984 (n=124) |
| Stability | Meet product claims for shelf-life, open-container, and calibration | 24 month shelf-life, 14 day open container stability, 14 day calibration stability | 24 month shelf-life, 14 day open container stability, 14 day calibration stability |
| Imprecision (Within-Run) | Low Coefficient of Variation (CV) | Level 1: 2.5% CV (Mean 70.3 mg/dL) | |
| Level 2: 2.9% CV (Mean 106 mg/dL) | Level 1: 3.2% CV (Mean 18.8 mg/dL) | ||
| Level 2: 3.4% CV (Mean 42.9 mg/dL) | |||
| Level 3: 2.5% CV (Mean 65.5 mg/dL) | |||
| Imprecision (Total) | Low Coefficient of Variation (CV) | Level 1: 3.0% CV (Mean 70.3 mg/dL) | |
| Level 2: 3.6% CV (Mean 106 mg/dL) | Level 1: 3.4% CV (Mean 18.8 mg/dL) | ||
| Level 2: 5.2% CV (Mean 42.9 mg/dL) | |||
| Level 3: 3.7% CV (Mean 65.5 mg/dL) |
Note: The document states "Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagents to the IMMAGE System Reagents." The specific numerical acceptance criteria (e.g., minimum 'r' value, maximum %CV) are not explicitly stated but are implicitly met by the reported results being considered sufficient for substantial equivalence.
2. Sample sized used for the test set and the data provenance
- Method Comparison Test Set Sample Size:
- Complement C3: 100 samples
- Complement C4: 124 samples
- Imprecision Study Sample Size: For both C3 and C4, 80 replicates were used per level for each precision type (within-run and total precision). This typically involves multiple runs over several days.
- Data Provenance: Not explicitly stated, but based on the manufacturer's location (Brea, California, USA) and the context of a 510(k) submission in the US, it is highly probable that the studies were conducted in the USA using human serum samples. The data is retrospective in the sense that it's analyzed after the experiments are conducted to demonstrate performance. The nature of these in vitro diagnostic (IVD) performance studies would generally be considered prospective experimentation designed to validate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of IVD device (quantitative determination of complement proteins) does not typically involve "experts" establishing a subjective ground truth for a test set. The "ground truth" for the method comparison study is the result obtained from the predicate device (Beckman's Immunochemistry Systems Complement C3 Reagent on the Array for C3, and Complement C4 Reagent on the Array for C4). These predicate devices are already established and accepted for their performance in quantifying C3 and C4.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As described above, this is an IVD device measuring quantitative analytes. Ground truth is established by a reference method (the predicate device), not through expert adjudication of images or clinical cases.
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 not an AI-assisted diagnostic device, nor does it involve "human readers" in the sense of interpreting medical images or clinical scenarios that would warrant an MRMC study. It is an automated immunochemistry system for quantitative measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (method comparison, stability, imprecision) demonstrate the "standalone" performance of the IMMAGE™ Immunochemistry System C3 and C4 Reagents when run on the IMMAGE™ system. The performance metrics are derived directly from the instrument's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the method comparison was the results obtained from the legally marketed predicate devices (Beckman Immunochemistry Systems Complement C3 and C4 Reagents on the Array System). For the stability and imprecision studies, the ground truth is inherently the true concentration of the analyte in the control/sample material, which is typically established through rigorous characterization and reference methods.
8. The sample size for the training set
This document does not describe a "training set" in the context of machine learning or AI. This is a traditional IVD device, and the method comparison and precision studies involve "test sets" for performance validation.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this traditional IVD device.
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