Search Results

The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE Immunochemistry System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Beckman IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance metrics like slope, intercept, r, or %C.V. Instead, it presents the results of studies and implies that these results demonstrate "substantial equivalence to chemistry test systems already in commercial distribution."

However, based on the provided data, we can infer the reported performance, which implicitly functions as the evidence for meeting implied acceptance.

• 24 month shelf-life
• 14 day open container stability
• 14 day calibration stability |
  | Within-Run Imprecision| Low Coefficient of Variation (%C.V.) at different analyte levels. | IGG Reagent (Serum):
  Level 1: 549 mg/dL (mean), 10.8 mg/dL (SD), 2.0 %C.V.
  Level 2: 1293 mg/dL (mean), 203 mg/dL (SD)
  Level 3: 2362 mg/dL (mean), 51 mg/dL (SD)
  IGG Reagent (CSF):
  Level 1: 1.62 mg/dL (mean), 0.086 mg/dL (SD), 5.3 %C.V.
  Level 2: 7.85 mg/dL (mean), 0.104 mg/dL (SD), 1.3 %C.V.
  Level 3: 13.5 mg/dL (mean), 0.52 mg/dL (SD), 3.9 %C.V.
  (Incomplete data for IGA and IGM imprecision in the provided text, but the format implies similar data was used.) |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Sizes (Method Comparison):
  • IMMAGE IGG (Serum): 323 samples
  • IMMAGE IGG (CSF): 100 samples
  • IMMAGE IGA (Serum): 289 samples
  • IMMAGE IGM (Serum): 247 samples
• Sample Sizes (Imprecision):
  • IGG (CSF) Levels: 30 samples for each of the 3 levels.
  • The sample size for serum IGG imprecision is not explicitly stated as 'n' is missing from the table although it shows 3 levels of measurement.
  • The sample sizes for IGA and IGM imprecision are not fully provided due to formatting issues in the input.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions serum and CSF sample types.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (expert involvement for ground truth) is not applicable to this device. This is a quantitative diagnostic device that measures immunoglobulin levels. The "ground truth" is established by the performance of the predicate device (Beckman Immunochemistry Systems Reagents) and the inherent chemical/physical properties being measured. There are no human experts "interpreting" results for a ground truth in the way there would be for image-based diagnostic systems.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective assessments, such as expert interpretation of medical images. For a quantitative measurement device, the "ground truth" for comparison is the measurement obtained from the predicate device.

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 is not applicable to this device. An MRMC study assesses human reader performance, often with and without AI assistance, particularly in areas like medical imaging. The IMMAGE system is a laboratory instrument for quantitative measurement, not a system intended to assist human "readers" in interpreting complex qualitative data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire performance study described is essentially a "standalone" or "algorithm only" performance for the IMMAGE system reagents. The device itself performs quantitative measurements without human intervention in the measurement process once the sample is loaded. The tables show the performance of the IMMAGE system's measurement compared to the predicate device's measurement.

7. The Type of Ground Truth Used

The "ground truth" in these studies is the measurement obtained from the predicate device (Beckman Immunochemistry Systems Immunoglobulin Reagents). The studies are designed to show that the new IMMAGE system provides results that are substantially equivalent to a legally marketed equivalent device. This is a form of comparative ground truth against an established, accepted diagnostic method.

8. The Sample Size for the Training Set

The document does not mention a "training set." This terminology is more common for machine learning or AI-based devices. For a conventional in-vitro diagnostic (IVD) device like this, there isn't a "training set" in the same sense. The device is developed and validated through chemical and instrument design, followed by performance studies (method comparison, stability, imprecision) using a series of collected samples.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" described in the context of this traditional IVD device, this question is not applicable. The underlying "ground truth" for the development of such reagents would be established through established analytical chemistry principles and assays used to characterize reference materials and calibrate the system.

Ask a specific question about this device