(44 days)
The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.
The IMMAGE Immunochemistry System B2M Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of beta-2-microglobulin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
The Beckman IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent is intended for the quantitative determination of human beta-2-microglobulin in serum by rate nephelometry. The study provided focuses on demonstrating substantial equivalence to a predicate device through method comparison, stability, and imprecision experiments, rather than establishing acceptance criteria against a specific clinical performance threshold.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for each performance metric. Instead, it presents the results of studies and implies that these results demonstrate substantial equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Demonstrate substantial equivalence to the predicate device | Data presented (though not fully legible in the provided snippet) suggests comparison to Array System Beta-2-Microglobulin reagent. The summary states "Equivalence is demonstrated through method comparison..." |
| Shelf-life Stability | Meet product claim | 24 month shelf-life |
| Open Container Stability | Meet product claim | 14 day open container stability |
| Calibration Stability | Meet product claim | 14 day calibration stability |
| Within-Run Imprecision | Low variability at different concentration levels (typical for IVD) | Level 1: Mean 0.34 mg/dL, SD 0.029 mg/dL, %CV 8.5 (N=80) |
| Level 2: Mean 1.65 mg/dL, SD 0.045 mg/dL, %CV 2.7 (N=80) | ||
| Level 3: Mean 3.43 mg/dL, SD 0.099 mg/dL, %CV 2.9 (N=80) |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Study: The snippet of the table for method comparison is largely unreadable. It's impossible to determine the sample size from the provided text.
- Imprecision Study (Within-Run): A sample size of N=80 was used for each of the three levels tested.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Typically, such studies for device submission are prospective and conducted in clinical laboratory settings.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The IMMAGE Immunochemistry System B2M Reagent is an in-vitro diagnostic (IVD) device that quantitatively measures a biomarker (Beta-2-Microglobulin). The "ground truth" for such devices is typically established by reference methods or validated comparative methods, not by expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as it pertains to subjective interpretations or classifications, which is not the nature of this quantitative IVD device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images, often with and without AI assistance. The Beckman IMMAGE system is a laboratory instrument for quantitative biomarker measurement.
6. Standalone (Algorithm Only) Performance Study
The provided document describes the performance of the entire device system (reagent with the IMMAGE Immunochemistry System), not just an isolated algorithm. The "algorithm" in this context is the rate nephelometry methodology, which is an integral part of the measurement system. Therefore, a standalone algorithm-only performance study as understood in the context of AI tools is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by quantitative measurements derived from comparison to a predicate device (Array System Beta-2-Microglobulin (B2M) reagent) and through internal analytical performance studies (stability, imprecision). For quantitative assays, "ground truth" often refers to the true concentration of the analyte, frequently determined by validated reference methods or the performance of a legally marketed predicate device.
8. Sample Size for the Training Set
This information is not explicitly stated and is likely not applicable in the context of traditional IVD device development for chemical reagents and equipment. The IMMAGE Immunochemistry System B2M Reagent uses a nephelometric methodology. This is a physics-based measurement technique, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a system involves calibrating the instrument with known standards to establish a calibration curve. Sample preparation and testing involves real patient samples (test set), but not algorithm training.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" with established ground truth in the machine learning sense for this traditional IVD device. The calibration of the system would involve using known calibrator materials (e.g., Beckman Calibrator 2, mentioned in the Intended Use) with assigned values, which act as the "ground truth" for the instrument's calibration curve.
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.