(69 days)
The VARIANT™ II ß-thalassemia Program is intended for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).
The VARIANT™ II ß-thalassemia Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System
For in vitro diagnostic use only.
The VARIANT™ II is a fully automated HPLC system which can be used to separate and determine area percentages for hemoglobins A, and F and to provide qualitative determinations of abnormal hemoglobins.
The VARIANTM II B-thalassemia Short Program utilizes principles of ion exchange high performance liquid chromatography(HPLC). The samples are automatically mixed and diluted on the VARIANT™ II Sampling Station(VSS) and injected into the analytical cartridge. This is a change from the unmodified program(VARIANT) where samples had to be mixed and diluted manually before being placed on the instrument. The VARIANT™ II chromatographic station(VCS) dual pumps deliver a programmed buffer gradient of increasing ionic strength to the cartridge, where the HbA, F are separated based on their ionic interactions with the cartridge material. The separated HbA. F then pass through the flow cell of the filter photometer, where changes in the absorbance at 415 nm are measured. An additional filter at 690 nm corrects the background absorbance. The VARIANT™ II Clinical Data Management(CDM) software performs reduction of raw data collected from each analysis. One level calibration is used for the adjustment of the calculated HbAyF values. A patient sample report and a chromatogram are generated by CDM for each sample. Minor differences in the separation efficiency of individual analytical cartridges are corrected by the use of the Hemoglobin A /F Calibrator.
The provided text does not contain detailed acceptance criteria or a specific study that outlines numerical performance metrics for the device, beyond a general statement that "Testing met all acceptance criteria" and demonstrated "excellent concordance between the two methods."
Therefore, much of the requested information cannot be extracted from the given document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in numerical terms. | "Testing met all acceptance criteria." |
| "excellent concordance between the two methods [VARIANT and VARIANT II B-thalassemia programs]." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth or their qualifications. Given the nature of the device (HPLC for hemoglobin analysis), it is likely that a reference method or clinical samples with known diagnoses served as the ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method.
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. The device is an automated HPLC system for hemoglobin analysis, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (VARIANT™ II β-thalassemia Program) is an automated system for chemical analysis, implying standalone performance. The document describes it as "a fully automated HPLC system which can be used to separate and determine area percentages for hemoglobins A, and F and to provide qualitative determinations of abnormal hemoglobins."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. However, given that it compares the "VARIANT™ II β-thalassemia Program" with the "unmodified program (VARIANT)," it is highly probable that the ground truth was established by:
- Reference methods: Confirmed analysis from established, highly accurate methods for hemoglobin quantification and identification.
- Clinical samples with confirmed diagnoses: Samples from patients with known β-thalassemia or other hemoglobinopathies.
The term "concordance between the two methods" suggests a comparison against the existing VARIANT system, which would serve as a de facto reference in this context for evaluating the modified device.
8. The sample size for the training set
The document does not specify a training set or its size. As this is a 510(k) submission for a device modification (primarily automating sample preparation), it's more likely that the validation focused on performance equivalence rather than machine learning algorithm training.
9. How the ground truth for the training set was established
Not applicable, as a training set is not mentioned in the context of the device's development or evaluation in this document.
§ 864.7400 Hemoglobin A
2 assay.(a)
Identification. A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).(b)
Classification. Class II (performance standards).