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The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).

The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.

The G7 Automated HPLC Analyzer - Beta-thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. A chromatographic tracing of the hemoglobin products found in the sample is also produced which allows for the comparison of an individual chromatogram with standard patterns of known composition. The operational portion of the G7 Beta-thalassemia Mode is composed of a sampling unit, liquid pump, degasser, detector, microprocessors, sample loader, floppy disk drive unit, operational panel and a printer all of which have already been cleared by the FDA (K011434). The reagents and software program specific to the Beta-thalassemia Mode consist of calibrators, elution buffers, column and software only.

The G7 Automated HPLC System - Beta-thalassemia Mode uses a cation exchange column and separates the hemoglobin in the blood into fractions. The separation is accomplished by eluting the hemoglobins from the column with a gradient of three elution buffers containing increasing salt concentrations. The resulting report is printed out on the on-board printer and can be stored on a floppy disk in the on-board floppy disk drive. The data can also be transmitted to a host computer through the RS232 port. The result report includes a sample ID, date, time, area percentages and retention time in minutes of each individual peak detected. Peaks that meet the retention time "windows" pre-set in the software are labeled as F, A0, A2, D+, S+, C+. All others are designated in order of appearance as PXX and are listed in order of appearance.

All automated processes in the G7 Beta-thalassemia Mode are controlled by internal microprocessors using software downloaded via the on-board floppy disk drive.

The Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for in vitro diagnostic use for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in detecting and presumptively identifying abnormal hemoglobins in whole blood using ion-exchange high-performance liquid chromatography (HPLC).

Here’s a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices, where the device's performance (correlation, imprecision) should be comparable to or better than the predicate.

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

• Quantitative HbA2 Test Set:
  • Sample Size: 75 patient specimens.
  • Data Provenance: Not explicitly stated, but "Patient specimens were analyzed" suggests clinical samples. The type of study (retrospective/prospective) is not specified, but typically, these comparative studies are conducted prospectively or using archived clinical samples.
• Quantitative HbF Test Set:
  • Sample Size: 57 patient specimens.
  • Data Provenance: Not explicitly stated, but "Patient specimens were analyzed" suggests clinical samples. The type of study is not specified.
• Qualitative Hemoglobin Identification Test Set:
  • Sample Size: 155 total comparisons (patient whole blood samples).
  • Data Provenance: Whole blood from patients "suspected of having hemoglobinopathies" were tested. This suggests clinical samples with a range of conditions. The type of study is not specified.

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

The ground truth for the test set was not established by human experts in the traditional sense. Instead, it was established by predicate devices that are already commercially available and considered legally marketed for their respective intended uses.

• For quantitative HbA2, the predicate device was Helena Laboratories' Beta-Thal HbA2 Quik Column™.
• For quantitative HbF, the predicate device was Bio-Rad Laboratories VARIANT™ BETA-THALASSEMIA SHORT PROGRAM.
• For qualitative hemoglobin identification, the predicate device was Beckman Paragon® Hemoglobin Electrophoresis.

4. Adjudication Method for the Test Set

There was no human "adjudication method" in the context of resolving disagreements between multiple human readers. The comparison was directly between the Tosoh G7 device and the predicate laboratory devices. The "ground truth" for each sample was implicitly determined by the result from the predicate device (or in the case of qualitative identification, agreement with the predicate result).

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

No MRMC comparative effectiveness study was done. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool designed to improve human reader performance. The study focuses on the device's analytical performance compared to established laboratory methods.

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

Yes, a standalone performance study was done. The G7 Automated HPLC Analyzer: Beta-thalassemia Mode operated as an algorithm-only device (i.e., automated instrument) to process samples and generate results, which were then compared against established predicate devices. There is no human interaction described as part of its performance in these studies, only in the interpretation of its results.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance studies was based on results obtained from legally marketed predicate laboratory devices. These predicate devices represent established and accepted methods for measuring HbA2, HbF, and identifying abnormal hemoglobins.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the device's software or analytical methods. This is a traditional in vitro diagnostic device, not a machine learning or AI algorithm that typically goes through a distinct training phase with a labeled dataset. The instrument and its software, including elution protocols and peak "windows," are developed and validated by the manufacturer internally, but a dedicated "training set" in the AI sense is not usually disclosed or relevant for such devices in an FDA submission of this nature.

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

As noted above, a "training set" in the context of, for example, a machine learning model is not applicable here. The ground truth for the development and internal validation of the instrument's operational parameters (e.g., software "windows" for hemoglobin components) would have been established through extensive analytical testing by the manufacturer, likely using characterized samples and reference methods. However, the details of this internal development and validation are not part of this 510(k) summary, which focuses on the comparative study for substantial equivalence.

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