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The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids.
The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features barcode identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with reagents and reaction constituents. The system analyzes up to 72 samples per run with up to 24 analytes per sample. Major hardware components include a reagent compartment, and reagent cranes, reaction module, sample carousel and crane, sample hydropheumatics, electronics, and power supplies.
Acceptance Criteria and Study for IMMAGE™ Immunochemistry System
This report summarizes the acceptance criteria and the study that demonstrates the IMMAGE™ Immunochemistry System meets these criteria, based on the provided text.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the IMMAGE™ Immunochemistry System are implicitly defined by its ability to demonstrate "Substantial Equivalence" to existing predicate devices. This equivalence is primarily shown through method comparison and imprecision studies. While explicit numerical acceptance criteria for slope, intercept, correlation coefficient (r), and %CV are not stated in the document as pre-defined "acceptance criteria," the reported performance values are presented to demonstrate substantial equivalence. Therefore, the reported performance metrics can be considered as the evidence meeting the underlying requirement for substantial equivalence.
Table 1: Acceptance Criteria (Implicit) and Reported Device Performance
| Performance Metric | Implicit Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance | Comments |
|---|---|---|---|
| Method Comparison | Determined by comparing the IMMAGE System to predicate devices. Strong correlation and slopes/intercepts close to 1 and 0, respectively, indicate substantial equivalence. | ||
| Slope | Close to 1.0 (indicating proportional agreement with predicate) | 0.9789 - 1.1108 (Range across analytes) | All slopes are close to 1.0, demonstrating proportional agreement. |
| Intercept | Close to 0.0 (indicating no significant constant bias) | -10.06 - 8.05 (Range across analytes) | Most intercepts are close to 0, indicating minimal constant bias. Transferrin/serum has the largest negative intercept, while Complement C3 has the largest positive. |
| Correlation Coefficient (r) | High (e.g., >0.95, indicating strong linear relationship) | 0.940 - 0.998 (Range across analytes) | All 'r' values are high, indicating a strong linear relationship with the predicate methods. The lowest 'r' is for Rheumatoid Factor (0.940), which is still generally considered a strong correlation in these types of studies. |
| Within-run Imprecision (%CV) | Low (indicating good precision and reproducibility) | 1.1% - 7.2% (Range across analytes and levels) | All %CVs are relatively low, demonstrating good within-run precision for all tested analytes across different concentration levels. The highest %CV is Digoxin, Level 2 (7.2%). |
2. Sample Size and Data Provenance
- Test Set Sample Size: For the estimated within-run imprecision study, a sample size of N=80 measurements was used for each analyte at each of three different levels (e.g., Apolipoprotein A Level 1, Level 2, Level 3 each had N=80). The text does not explicitly state the sample size for the method comparison study (slope, intercept, r).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission in the US (Beckman Instruments, Inc., Brea, California), it is highly probable the studies were conducted in the US, likely within a laboratory setting. The nature of these studies (method comparison and imprecision) typically involves prospective collection of samples for dedicated analytical runs.
3. Number and Qualifications of Experts for Ground Truth
This type of device (an immunochemistry analyzer) does not typically rely on human expert consensus for "ground truth" in the same way an imaging AI device would. The "ground truth" for the test results is established by the performance of the predicate devices themselves, which are already cleared for clinical use and whose accuracy is accepted. The "experts" implied here would be clinical laboratory professionals following standard testing protocols. No specific number or qualifications of experts are mentioned for establishing the ground truth, as it's defined by the established analytical methods of the predicate devices.
4. Adjudication Method
Not applicable for this type of device performance study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish a gold standard, such as in diagnostic imaging. For quantitative analytical devices, the "truth" is determined by the reference measurement method (predicate device) and analytical precision.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. MRMC studies are primarily relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists, pathologists) and where the AI assists or replaces that interpretation. The IMMAGE™ Immunochemistry System is an automated analytical instrument; its performance is compared to other instruments, not human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Method Comparison Study Results" and "Estimated Within-run Imprecision" directly represent the standalone performance of the IMMAGE™ Immunochemistry System, demonstrating its analytical capabilities (accuracy relative to predicates and precision) without human intervention in the result generation or interpretation process beyond operating the instrument. The device itself provides quantitative measurements.
7. Type of Ground Truth Used
The type of ground truth used for the method comparison study is the results obtained from established predicate devices. For analytical precision, the ground truth is statistical measurements based on repeated analyses of control materials or patient samples, where the "true" value is an accepted reference or a statistically derived mean.
8. Sample Size for the Training Set
The document does not provide information on a "training set" or its sample size. This is because the IMMAGE™ Immunochemistry System is an analytical instrument, not a machine learning or AI algorithm in the contemporary sense that would require a distinct "training set" for model development. The data presented relates to the validation of the finalized system.
9. How Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no explicit mention of a "training set" in the context of this device's submission. The "ground truth" for device validation is based on comparison to predicate methods and established analytical principles.
§ 862.2700 Nephelometer for clinical use.
(a)
Identification. A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.(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.