Search Results

For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.

The ADVIA 60 with software version 1.6 is a bench top, clinical laboratory instrument that analyzes in-vitro samples of whole blood specimens. The device reports a complete blood count (CBC) and 3-part WBC differential (LMG). The device operates as either a closed tube/closed system or open tube/open system. The ADVIA 60 can evaluate 5, 8, 16, or 18 hematology parameters depending on its internal configuration.

The provided text describes the ADVIA 60 Software Version 1.6 as an in-vitro diagnostic device for quantitative determination of blood cells and hematologic parameters. It aims to demonstrate substantial equivalence to its predicate devices, the ADVIA 60 with software version 1.4 and Abbott Cell-Dyn 4000.

Here's an analysis based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The documentation focuses on demonstrating substantial equivalence rather than explicit acceptance criteria with numerical thresholds. However, it implicitly uses accuracy, precision, and linearity as key performance indicators for comparison.

Note: The document does not provide specific numerical ranges or statistical metrics for "equivalent" performance; it relies on a general statement of equivalence.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "The test results included in this submission demonstrate..."

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

The document does not provide any information regarding the number of experts used, their qualifications, or their involvement in establishing ground truth for the test set. Given the nature of a hematology analyzer, ground truth would typically be established by laboratory methods, not expert consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. This is expected as the device is an automated hematology analyzer, and its performance is typically evaluated against reference methods or predicate devices, not through expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is an automated hematology analyzer, not a diagnostic imaging or interpretation tool that would involve human readers. The study focuses on the device's performance characteristics compared to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies conducted were standalone performance evaluations. The ADVIA 60 Software Version 1.6 is an automated instrument, and its performance is measured directly by comparing its output against predicate devices or reference methods. There is no human interpretation or involvement in the measurement process being evaluated.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation implicitly relies on:

• Established performance of predicate devices: The ADVIA 60 with software version 1.4 and the Abbott Cell-Dyn 4000 are used as benchmarks. Their established accuracy, precision, and linearity serve as the de-facto "ground truth" for comparison.
• Fundamental scientific measurement principles: For parameters like hemoglobin, it refers to a "modification of the manual cyanmethemoglobin method developed by the International Committee for Standardization in Hematology," implying a gold standard reference method for that specific measurement. Similarly, RBC/WBC/Plt counting is based on "impedance variation," a well-established principle for cellular enumeration.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This is typical for device submissions that focus on performance validation rather than detailing the underlying algorithmic development and training data.

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

As no training set is mentioned, there is no information on how its ground truth would have been established.

Ask a specific question about this device