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510(k) Data Aggregation
(355 days)
IMMAGE® Immunochemistry Systems IGMLC Reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of immunoglobulin M in human serum or cerebrospinal fluid (CSF) by rate nephelometry.
CSF Cal (Cerebrospinal Fluid Protein Calibrator), when used in conjunction with Beckman Coulter Low Concentration Immunoglobulin A (IGALC) and Low Concentration Immunoglobulin M (IGMLC) reagents is intended for use on Immage for the calibration of these reagents.
The IMMAGE System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator is intended for the quantitative determination of human Immunoglobulin M in serum and cerebrospinal fluid (CSF) by rate nephelometry.
The IMMAGE Immunochemistry System (cleared under K962294) is a high throughput, random access analyzer that uses rate nephelometry methodology to measure human immunoglobulin M concentration in serum and CSF samples. The IMMAGE Immunochemistry System automatically dilutes and delivers sample to the reaction cuvette along with reagents and other reaction constituents.
During the reaction, particle bound anti-IgM antibody binds to IgM molecules in the sample via an antigen-antibody reaction. This results in the formation of insoluble complexes causing an increase in light scatter. The rate of increase in light scattered from the particles suspended in solution is directly proportional to the concentration of immunoglobulin M in the sample.
The rate nephelometer measures the increase in the intensity of light scattered by particles suspended in a cuvette. The light source for the rate nephelometer is a 670 nm wavelength laser. The detector is placed at a 90° angle from the incident beam to measure light increase. At the end of the reaction, the system mathematically calculates the rate of change of the scatter signal.
Here's an analysis of the acceptance criteria and study as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Sample Type | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Method Comparison | ||||
| Slope | CSF | 1.0 +/- 0.10 | 0.963 | Pass |
| Intercept | CSF | = 0.95 | 0.997 | Pass |
| Slope | Serum | 1.0 +/- 0.10 | 1.048 | Pass |
| Intercept | Serum | N/A | 5.70 | Pass |
| R | Serum | >= 0.95 | 0.997 | Pass |
| Precision | (See detailed results below) | Pass | ||
| CSF1 Mean | CSF | N/A | 0.196 mg/L | N/A |
| CSF1 Total CV | CSF | N/A | 15.64% | N/A |
| CSF2 Mean | CSF | N/A | 2.49 mg/L | N/A |
| CSF2 Total CV | CSF | N/A | 2.85% | N/A |
| CSF3 Mean | CSF | N/A | 8.81 mg/L | N/A |
| CSF3 Total CV | CSF | N/A | 4.30% | N/A |
| Serum1 Mean | Serum | N/A | 38.5 mg/L | N/A |
| Serum1 Total CV | Serum | N/A | 10.84% | N/A |
| Serum2 Mean | Serum | N/A | 1250.1 mg/L | N/A |
| Serum2 Total CV | Serum | N/A | 2.85% | N/A |
| Serum3 Mean | Serum | N/A | 1935.8 mg/L | N/A |
| Serum3 Total CV | Serum | N/A | 3.28% | N/A |
Note: The document only provides Acceptance Criteria for the Method Comparison study. Although detailed precision results are reported, explicit acceptance criteria for these were not stated in the provided text. The document generally states that "Equivalence is demonstrated through method comparison, linearity, and imprecision, and sensitivity experiments," implying the precision results were considered acceptable for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Method Comparison: 80 for CSF and 80 for Serum.
- Sample Size for Precision Study: Each of the 6 samples (3 CSF, 3 Serum) was tested 80 times ("N = 80"). This likely indicates 80 replicates per sample.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The device is a quantitative immunoassay system, and the ground truth for such devices is typically established by reference methods or standards, not by expert interpretation. The term "ground truth" as it relates to expert consensus is usually applicable to diagnostic imaging or pathology, which is not the case here.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are interpreting images or clinical data, and their interpretations need to be reconciled to establish a consensus ground truth. This device is a fully automated immunoassay system that provides quantitative results.
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
This information is not provided and is not applicable to this device. An MRMC study with human readers assisting or being assisted by AI is relevant to diagnostic interpretation (e.g., radiology AI). This device is a laboratory instrument that quantifies immunoglobulin levels; it does not involve human interpretive reading in the same way.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is a standalone device performance study. The IMMAGE® Immunochemistry System is an automated system designed to quantitatively determine human Immunoglobulin M levels. The studies described (method comparison, linearity, imprecision, sensitivity) assess the performance of the algorithm/instrument system itself, without human intervention in the primary measurement process.
7. The type of Ground Truth Used
The ground truth for the method comparison study was established by comparing the results of the modified device to the "current assay" (which is the predicate device, K993547). The clinical significance section also refers to established medical literature and standards. Specifically, for calibrator traceability, it mentions improved traceability to the international standard, ERM-DA-470(k)-IFCC. Therefore, the ground truth is based on:
- Comparison to a legally marketed predicate device/current assay
- Traceability to an international standard (for calibrator)
8. The Sample Size for the Training Set
This information is not provided in the document. The term "training set" is typically used in the context of machine learning or AI algorithm development. This submission describes a re-submission of an established immunoassay system with optimizations (e.g., reagent curve fit, analytical range, traceability). While there might have been internal studies or data used to refine these optimizations, the document does not refer to them as "training sets" in the AI sense, nor does it specify their size.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not directly applicable in the context of "training set" as understood in AI/ML. As mentioned above, the submission focuses on verifying the performance of an optimized immunoassay system against an existing predicate and international standards, rather than training a novel AI algorithm.
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