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510(k) Data Aggregation
(149 days)
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
The IMMAGE Immunochemistry System Alpha-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha-antitrypsin by rate nephelometry.
The IMMAGE Immunochemistry System AAT Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of alpha-antitrypsin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
The provided text describes the Summary of Safety & Effectiveness for the BECKMAN IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent. This document is a 510(k) Notification, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through a clinical trial with acceptance criteria.
Therefore, the information you've requested regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not typically found in this type of submission for this kind of device (a laboratory reagent for an existing immunochemistry system). This document focuses on demonstrating that the new reagent performs similarly to an already approved predicate device.
However, I can extract the performance data that is provided to show how the device's performance was characterized.
Here's a breakdown of the available information:
Description of the Study and Device Performance
The study presented here is a demonstration of substantial equivalence for a new reagent (IMMAGE™ Immunochemistry System Alpha-Antitrypsin (AAT) Reagent) compared to a predicate device (Beckman Alpha₁-Antitrypsin (AAT) Reagent) on an existing immunochemistry system. The core of the study involves method comparison, stability, and imprecision experiments. These experiments aim to show that the new IMMAGE system reagent performs comparably to the predicate reagent when both are used on their respective systems (IMMAGE vs. Array® 360).
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit "acceptance criteria" in the sense of a clinical trial's pre-defined thresholds for metrics like sensitivity, specificity, or AUC are not provided. This is a 510(k) for a reagent, and the goal is to show equivalence to a predicate. The performance data focuses on precision and stability.
| Performance Metric | Reported Device Performance (IMMAGE AAT Reagent) |
|---|---|
| Method Comparison | Data provided in a tabular format, but the specific statistical results (e.g., correlation coefficient, accuracy at different levels) for the comparison between IMMAGE System AAT and Beckman Array® Systems AAT are unreadable due to OCR issues in the provided text snippet. The document states, "Equivalence is demonstrated through method comparison... experiments that results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent." |
| Stability | "14 day open container stability" is mentioned in comments, implying evaluation of the reagent's stability after opening. No specific quantitative criteria or results are readable. |
| Imprecision (Total) | High Serum Levels |
| - Level 1 (Mean 70.1 mg/dL): SD = 2.33 mg/dL, %CV = 3.3 | |
| - Level 2 (Mean 296 mg/dL): SD = 8.2 mg/dL, %CV = 2.8 | |
| - Level 3 (Mean 509 mg/dL): SD = 16.4 mg/dL, %CV = 3.2 | |
| Low Serum Levels | |
| - Level 1 (Mean 10.9 mg/dL): SD = 0.40 mg/dL, %CV = 3.7 | |
| - Level 2 (Mean 44.3 mg/dL): SD = 0.73 mg/dL, %CV = 1.6 | |
| Imprecision (Within Run) | High Serum Levels |
| - Level 1 (Mean 70.1 mg/dL): SD = 1.87 mg/dL, %CV = 2.7 | |
| - Level 2 (Mean 296 mg/dL): SD = 6.2 mg/dL, %CV = 2.1 | |
| - Level 3 (Mean 509 mg/dL): SD = 15.9 mg/dL, %CV = 3.1 | |
| Low Serum Levels | |
| - Level 1 (Mean 10.9 mg/dL): SD = 0.36 mg/dL, %CV = 3.3 | |
| - Level 2 (Mean 44.3 mg/dL): SD = 0.72 mg/dL, %CV = 1.6 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Imprecision Study Test Set Sample Size:
- High Serum Levels: 80 data points for each of the three serum levels for both Within Run and Total Imprecision.
- Low Serum Levels: 30 data points for each of the two serum levels for both Within Run and Total Imprecision.
- Method Comparison Study Test Set Sample Size: Not explicitly stated or readable in the provided snippet.
- Data Provenance: Not specified (e.g., country of origin). The study appears to be an internal validation by the manufacturer, Beckman Instruments, Inc. It is likely prospective, as it involves testing the new reagent.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is not applicable to this submission. For a diagnostic reagent for quantitative measurement of a biomarker, "ground truth" is typically established by the inherent accuracy and reference methods of the predicate device and the analytical chemistry principles involved, rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This is not applicable as there is no "adjudication" of expert opinions for a quantitative laboratory reagent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human readers in interpretation. This document pertains to a laboratory reagent.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a reagent for an automated immunochemistry system, not a standalone AI algorithm. The performance described is the "standalone" performance of the reagent on the instrument.
7. The Type of Ground Truth Used
The "ground truth" for this device is effectively the quantitative concentration of alpha-antitrypsin in serum. This is established through the analytical precision and accuracy of the measurement system, benchmarked against the predicate device which has been previously deemed safe and effective. It's based on analytical measurement/biochemical principles rather than subjective interpretation, pathology, or outcomes data in the typical sense of a clinical trial for an AI or imaging device.
8. The Sample Size for the Training Set
This is not applicable. The device is a reagent, not an AI algorithm that requires a training set in the machine learning sense. The "development" of the IMMAGE AAT reagent would have involved chemical formulation and optimization, not algorithmic training on a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
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