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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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The G7 Automated HPLC Analyzer is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated system intended for wents obtained by this device are used in the management and treatment of diabetes.

The G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A1c (SA1c) percentage in whole blood. The operational portion of the HPLC G7 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer.

The G7 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A1a, A1b, F, L-A1c, SA1c and A0. The separation is done by eluting the hemoglobins from the column with a gradient of three elution buffers containing different salt concentrations. The result report is printed out from the on-board printer and can be stored on a floppy disk from the on-board floppy disk drive. The data can be transmitted to a host computer. The result report includes a sample ID, date, percentage and retention time of each fraction, SA1c percentage and total A1 percentage (A1a + A1b + SA1c) along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge. The software compares the retention times to "known windows" and designates the material as P0X or H-VX if it does not match a defined window.

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

This summary describes the Tosoh G7 Automated HPLC Analyzer in its HbA1c Variant Analysis Mode.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds. Instead, it demonstrates substantial equivalence to a predicate device (Tosoh A1c 2.2 Plus) by showing high correlation and precision. Therefore, the "acceptance criteria" are implied by the comparison to the predicate device and satisfactory statistical results.

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

• Sample Size: 230 patient samples
• Data Provenance: The document states "patient samples obtained from 230 patients." This implies clinical samples, likely from a patient population relevant to diabetes management. Given that the manufacturer is Tosoh Medics, Inc. based in South San Francisco, California, the data is likely from the United States, and it is almost certainly retrospective as samples were "obtained" and then assayed.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of consensus readings. Instead, the "ground truth" for the comparative analysis is implicitly the results obtained from the predicate device, the Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer. The study aims to show equivalence between the new device and the existing, cleared device, rather than establishing a completely independent ground truth.

4. Adjudication Method for the Test Set:

Not applicable. There was no expert "adjudication" in the traditional sense. The comparison was statistical against the predicate device's results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for an automated in vitro diagnostic device, not an imaging device requiring human interpretation, so MRMC studies are not relevant.

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

Yes, the study described is a standalone performance assessment of the G7 Automated HPLC Analyzer. It evaluates the device's analytical performance (comparative analysis, precision, recovery) in producing HbA1c results, without human interpretation of the chromatograms being the primary endpoint for clinical decision-making within the study design. The device is fully automated.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation was the results obtained from the predicate device (Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer). The study's objective was to demonstrate substantial equivalence to this already cleared device.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its sample size. For an IVD device like this, the development and training (calibration, algorithm optimization) would likely be an internal process before the equivalence study. The "230 patient samples" refer to the test set used for demonstrating substantial equivalence.

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

Not specified. As mentioned above, a separate training set is not explicitly detailed. The device likely uses internal calibration methods which would be established during development, rather than a "ground truth" for a machine learning training process described in the document. The device's operation relies on established HPLC principles and a "cation exchange column" with "three elution buffers." The software compares retention times to "known windows," implying pre-defined chemical properties rather than data-driven machine learning ground truth establishment.

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