(74 days)
The IMMAGE Immunochemistry System AlphaMacroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha macroglobulin by rate nephelometry. Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.
This is an in vitro diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, and training set information, are not applicable.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
The submission primarily focuses on establishing "substantial equivalence" to a predicate device, as opposed to defining explicit performance acceptance criteria with numerical targets. Equivalence is demonstrated through "method comparison, stability, and imprecision experiments."
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state numerical acceptance criteria. Instead, it refers to the demonstration of "substantial equivalence" through method comparison, stability, and imprecision experiments. Therefore, the "Reported Device Performance" is inferred from the results presented as part of demonstrating this equivalence, rather than direct numerical comparisons to pre-defined thresholds.
| Performance Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Substantial equivalence to predicate device (Beckman Alpha₂-Macroglobulin (AMG)) | Data presented supports substantial equivalence (detailed results not explicitly provided in extract, but stated as sufficient). |
| Stability | Acceptable stability over time | Stability study results presented (detailed results not explicitly provided in extract, but stated as sufficient). |
| Imprecision | Acceptable level of measurement variability | Imprecision study results presented (detailed results not explicitly provided in extract, but stated as sufficient). |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: Not explicitly stated in the provided text for method comparison, stability, or imprecision studies. The tables showing "Method Comparison Study Results," "Stability Study Results," and "Estimated Imprecision" are largely corrupted and do not provide clear numerical data on sample sizes.
- Data Provenance: Not explicitly stated. Given that it's a Beckman Instruments submission, it's likely internal company data, but the geographical origin or whether it's retrospective or prospective is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is an in vitro diagnostic device measuring a quantitative analyte, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for such devices typically refers to the true concentration of the analyte, often determined by reference methods or gravimetric preparation of calibrators/controls.
4. Adjudication Method
- Not Applicable. As this is an in vitro diagnostic device measuring a quantitative analyte, an adjudication method (like 2+1 or 3+1 used for expert consensus in image interpretation) is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is an in vitro diagnostic device, not an AI/ML system that assists human readers. Therefore, an MRMC study is not relevant.
6. Standalone Performance Study (Algorithm Only)
- Yes, in spirit. The performance data presented (method comparison, stability, imprecision) assesses the "algorithm only" in the sense that it measures the performance of the IMMAGE Immunochemistry System AMG Reagent as a standalone diagnostic assay on the IMMAGE system, without human interpretive input that would be common in AI/ML clinical decision support. The device is intended for quantitative determination by rate nephelometry, which is an automated process.
7. Type of Ground Truth Used
- For Method Comparison: The ground truth is established by the predicate device (Beckman Alpha₂-Macroglobulin (AMG) using the Array System) or another established method against which the new device's results are compared.
- For Stability and Imprecision: The ground truth is typically the known concentration of the analyte in control materials or patient samples, or the expected measurement derived from robust, repetitive testing.
8. Sample Size for Training Set
- Not Applicable. This is an in vitro diagnostic device with reagents and a defined measurement principle (rate nephelometry), not a machine learning algorithm that requires a "training set" in the AI/ML sense. Data is used for characterization, calibration, and validation rather than training a model.
9. How Ground Truth for Training Set Was Established
- Not Applicable. See reasoning for "Sample Size for Training Set."
§ 866.5620
Alpha -2-macroglobulin immunological test system.(a)
Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.(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.