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The Bio-Rad VARIANT™ II TURBO HbA Ic Kit - 2.0 is intended for the quantitative determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System. Measurement of hemoglobin Alc is effective in monitoring long term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT II TURBO HbAlc Kit - 2.0 is intended for professional Use.

The VARIANT II TURBO Hemoglobin Testing System is the next generation HPLC system with higher volume capability when compared to the VARIANT II testing system. The VARIANT II TURBO Hemoglobin Testing System provides an integrated method for sample preparation, separation, and determination of specific hemoglobin in whole blood. It is a fully automated, high-throughput system. It consists of 2 modules: the VARIANT II TURBO Sampling Station (VSS) and the VARIANT II TURBO Chromatographic Station (VCS). A personal computer (PC) is used to control the VARIANT II TURBO System using Clinical Data Management (CDM™) software. The CDM software supports import of sample information from and export of patient results to a Laboratory Information System (LIS). Control results are displayed on Levy-Jennings Charts and are exportable to Unity Real Time™.

The provided text describes a Special 510(k) Summary for a Device Modification related to the Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0. This type of submission is for modifications to a legally marketed device that do not significantly alter its performance specifications, intended use, or operating principles.

Crucially, the document explicitly states:

• "When compared to the predicate device, there are no changes to the performance specifications, intended or indications for use, or operating principles."
• "Performance Claims: No change, claims transferred from predicate device."

Therefore, this specific submission does not present new acceptance criteria or a new study to prove device performance, as the performance claims are directly transferred from the predicate device (K122472). The modifications described are primarily software and firmware updates, customer-requested features, and defect fixes.

The document focuses on demonstrating that these changes do not affect product safety, effectiveness, and substantial equivalency claims to the predicate device. This is achieved through a risk management process, review of modifications, and design verification/validation tests.

Based on the provided text, I cannot extract the specific acceptance criteria and a study proving those criteria were met for this modified device because the submission relies on the established performance of its predicate.

However, I can describe what the document does provide in relation to an implicit "acceptance" or validation of the modifications:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of new acceptance criteria for performance, nor new reported device performance data, because the performance claims are stated to be unchanged from the predicate device.

Instead, the "acceptance criteria" for the modifications themselves relate to successful verification and validation (V&V) testing.

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

The document details "design verification/validation tests" and a risk management process, but does not specify sample sizes for these tests. It also does not explicitly mention the country of origin or whether the data was retrospective or prospective, as the focus is on the software and firmware changes and their impact on safety and effectiveness, rather than a clinical performance study.

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

The document states: "For each identified risk, a Failure Mode and Effects Analysis (FMEA) was conducted. This was performed in a systematic manner by a trained risk assessment team until consensus was reached that an adequate analysis had been performed."

• Number of Experts: Not explicitly stated, but implies a "team" (more than one).
• Qualifications of Experts: Described as a "trained risk assessment team." No further specific qualifications (e.g., radiologist with X years of experience) are provided, which is typical for device engineering and risk management teams.

4. Adjudication Method for the Test Set

The FMEA process involved a "trained risk assessment team until consensus was reached," suggesting a form of group adjudication, but no specific method like "2+1" or "3+1" is detailed. It implies a collaborative decision-making process to reach agreement on risk identification and mitigation.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of results, where the AI might assist or replace that interpretation. This device is an automated in vitro diagnostic system for measuring HbA1c, and its modifications are software/firmware related, not involving human interpretation of clinical images or data in a way that would necessitate an MRMC study.

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

The device itself is an automated system. The "design verification/validation tests" would have evaluated the performance of the modified software and firmware in a standalone manner, integrated into the instrument, to ensure it met its functional and safety requirements. However, the document doesn't provide details on the specific "standalone" tests conducted beyond stating they "met established acceptance criteria" for the modifications.

7. The Type of Ground Truth Used

For the modifications, the "ground truth" was established based on:

• Identified potential risks and hazards (from reviewing modifications, design inputs, existing risk tables, customer complaints, and IEC 62304:2009 requirements).
• Predicate device claims and performance established during its initial clearance (K122472), against which the modified device's safety, effectiveness, and substantial equivalency were assessed.

For the predicate device's original performance claims (which are transferred), the ground truth for HbA1c measurement is based on:

• Certification by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT) Reference method.
• Certification by the IFCC as traceable to the IFCC Reference Measurement Procedure.

8. The Sample Size for the Training Set

Not applicable. This submission is for modifications to an existing in vitro diagnostic device, not a new algorithm that requires a "training set" in the context of machine learning. The software and firmware updates "include customer requested features, whereas both software and firmware include specific defect fixes," implying development rather than a machine learning training process.

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

Not applicable, as there is no mention of a machine learning "training set" in this context.

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The Bio-Rad VARIANT™ II Hemoglobin A Ic Program is intended for the percent determination of hemoglobin A Ic in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin Alc Program is intended for Professional Use Only. For in vitro diagnostic use. Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

The VARIANT™ II ß-thalassemia Short 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 Bio-Rad VARIANT II ß-thalassemia Short Program is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. Measurement of the percent hemoglobin A2 and F are effective in screening of ß-thalassemia (i.e., hereditary hemolytic anemias characterized by decreased synthesis or more types of abnormal hemoglobin polypeptide chains).

The VARIANT II Hemoglobin Testing System is a fully automated, highthroughput hemoglobin analyzer. The VARIANT II Hemoglobin Testing System provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobin in whole blood. It consists of two modules - the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT System using Clinical Data Management (CDM) Software.

A personal computer (PC) is used to control the VARIANT II Hemoglobin Testing System using Clinical Data Management (CDM™) software. The CDM software supports import of sample information from and export of patient results to a Laboratory Information System (LIS). Control results are displayed on Levy-Jennings Charts and are exportable to Unity Real Time™.

This K130860 submission is a Special 510(k) for a device modification, meaning the changes are to existing predicate devices (VARIANT II Hemoglobin A1c Program and VARIANT II ß-thalassemia Short Program) and aim to demonstrate substantial equivalence without impacting the core performance specifications, intended use, or operating principles. The modifications primarily involve software and firmware updates, along with a PC Board replacement.

Therefore, the study focuses on verification and validation (V&V) testing to ensure the modified device remains safe, effective, and substantially equivalent to its predicate. It does not present new performance data against specific acceptance criteria for diagnostic accuracy as would be expected for a novel device or a device with significant performance changes. Instead, it asserts that the changes do not affect the previously established performance claims.

Here's an analysis based on the provided text, focusing on how the device meets acceptance criteria related to its modifications:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a device modification submission where the performance specifications are stated to be unchanged from the predicate, the acceptance criteria are implicitly that the modified device's performance is at least as good as the predicate device and that the modifications do not introduce new risks or degrade existing performance. The "performance" reported is the outcome of the verification/validation and risk management processes.

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

The document does not specify a numerical sample size for a "test set" in the traditional sense of a clinical or analytical performance study. Given the nature of a Special 510(k) for software/firmware/hardware changes, the "test set" would refer to the data and scenarios used during verification and validation (V&V) testing.

• Sample Size: Not explicitly stated as a number of patient samples. The V&V efforts would likely involve testing various functionalities, defect fixes using specific test cases, and potentially a range of instrument data (already available or specifically generated for V&V).
• Data Provenance: Not explicitly stated. For "defect corrections," the data likely originated from "customer feedback" and scenarios that caused the identified defects. For general V&V, it would involve internal testing data. It's implied to be retrospective, as it addresses "customer feedback" and "defects" from prior versions, but specific details are absent.

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

This type of information is not applicable or not provided for this submission. The ground truth in this context is typically related to diagnostic accuracy, which is not being re-evaluated because performance claims are "transferred from predicate device."

For defect fixes, the "ground truth" would be whether the defect is successfully resolved and the intended functionality works as designed. This is assessed by engineering and quality assurance teams during V&V. The document mentions "a trained risk assessment team" for FMEA, but not "experts" establishing a diagnostic ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable/not provided. No "adjudication method" for interpreting results from a test set is mentioned because the submission directly states that performance specifications and claims are unchanged and transferred from the predicate. The "ground truth" for V&V testing of software/firmware changes is based on successful execution of tests and resolution of identified bugs, not on expert consensus interpretation of diagnostic output.

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

Not applicable. This device is an automated in vitro diagnostic (HPLC system) for measuring specific hemoglobin levels, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers. Therefore, an MRMC study is not relevant to this submission.

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

The device itself (VARIANT II Hemoglobin Testing System with CDM Software) operates as a standalone automated system for measurement. The changes are to its software/firmware. The V&V testing would assess the functionality of this automated system in its modified state. So, the testing effectively evaluates the "standalone" performance of the modified system, but it's not a new standalone study; it's a re-validation of the existing standalone system after modifications. The performance claims are asserted to be the same as the predicate (which was a standalone device).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the original predicate devices, the ground truth for establishing performance (e.g., accuracy of HbA1c or HbA2/F measurements) would have been based on comparison to reference methods or clinical outcomes.

For this specific submission (device modification):

• For defect corrections: The "ground truth" is the successful elimination of the defect and the proper functioning of the software features (e.g., CDM not crashing, calibrator reassignment working). This is validated through internal software testing.
• For performance: The submission directly states "No change or impact, claims transferred from predicate device." This means the ground truth for performance measures (precision, accuracy, linearity, etc.) was established during the original predicate device's clearance and is implicitly inherited rather than re-established in detail for this modification. The V&V here confirmed that the modifications did not degrade the ability to achieve those previously established performance characteristics.

8. The Sample Size for the Training Set

Not applicable/not provided. This device is not described as involving a machine learning algorithm that requires a "training set." The software and firmware updates are for controlling the HPLC system and managing data, not for learning from data in the way an AI algorithm would.

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

Not applicable. As no training set for a machine learning algorithm is involved, this question is not relevant to the submission.

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The Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0 is intended for the quantitative determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT™ II TURBO Hemoglobin Testing System. Measurement of hemoglobin A1c is effective in monitoring long term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT™ II TURBO HbA1c Kit-2.0 is intended for Professional Use Only.

The VARIANT II TURBO Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO HbA12 Kit - 2.0 is based on chromatographic separation of Hemoglobin A10 on a cation exchange cartridge. The VARIANT II TURBO HbA1c Kit - 2.0 contains an analytical cartridge, 5 prefilters, Elution Buffer A and B, Calibrator Level 1, Calibrator Level 2, Whole Blood Primer, sample vials and a CD-ROM with test parameters.

The VARIANT II TURBO Hemoglobin Testing System provides an integrated method for sample preparation, separation and the quantitative determination of HbAle in EDTA human whole blood. The VARIANT II TURBO Hemoglobin Testing System is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules - the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). There have been hardware updates due to obsolescence of parts and firmware updates to support the replacement hardware components.

A personal computer is used to control the VARIANT II TURBO Hemoglobin Testing System using updated Clinical Data Management (CDM) software version 5.1.1.

Here's an analysis of the provided 510(k) summary, structured to answer your questions about acceptance criteria and the supporting study:

Some of the requested information, such as the specific country of origin for the data, the exact qualifications of experts, and the adjudication method for the test set, are not explicitly detailed in the provided 510(k) summary. This is typical for such regulatory documents, which focus on summarizing key performance data rather than granular study design details.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Method Comparison" study were based on a relative bias not exceeding +/- 10% at the decision points of 6% and 9% HbA1c.

The "Analytical Specificity" study aimed to show no significant interference from common hemoglobin variants at specified concentrations.

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

• Sample Size (Method Comparison): 100 EDTA whole blood human samples and 16 samples prepared by mixing EDTA whole blood samples with either purified HbAo or purified HbA1c. Total: 116 samples.
• Sample Size (Analytical Specificity): Not explicitly stated as a number of individual samples, but described as "Two fresh, EDTA non-variant human blood sample pools at 6.5% and 8.0-9.0% HbA1c" and "Fresh, EDTA human homozygous blood samples for each of the 4 hemoglobin variants (e.g. E, D, S, and C)." Series of test sample pools prepared by dilution.
• Data Provenance: The data used for method comparison and analytical specificity were "EDTA whole blood human samples" and "fresh, EDTA human homozygous blood samples." The country of origin is not specified but is implicitly from a clinical laboratory setting. The studies appear to be prospective or concurrent as they involved preparing and running samples specifically for the study.

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

This information is not provided in the summary. The ground truth for the method comparison study was established by the predicate device's software version 4.03. For the analytical specificity, the "true" HbA1c values for the variant samples were likely determined by a reference method or assumed based on the preparation of the samples (e.g., dilution of homozygous variant samples).

4. Adjudication Method for the Test Set

This information is not provided in the summary. For a quantitative assay like HbA1c, adjudication typically involves comparing the device's results against a gold standard or a highly accurate reference method. In the method comparison, the predicate device's results served as the reference for the modified software.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This document describes a medical device, the Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0, which is an automated in vitro diagnostic (IVD) assay to measure HbA1c. It is not an AI-based diagnostic tool that assists human readers/interpreters.

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

The device itself is a standalone automated system for quantitative determination of HbA1c. The evaluation performed (method comparison and analytical specificity) effectively represents its standalone performance because it directly measures HbA1c levels without human interpretation of complex images or signals requiring AI assistance. The study compares the performance of the updated software/system to a previous version, which is a standalone comparison.

7. The Type of Ground Truth Used

• Method Comparison: The ground truth for the method comparison study was established by the predicate device's software version 4.03 (meaning the measurements obtained from the same system running the older software). This is a "comparative ground truth" when assessing software changes.
• Analytical Specificity: For variant interference, the ground truth was effectively implicit in the preparation of the samples (known variant concentrations, and expected HbA1c values in the pools). The goal was to show that the presence of these variants does not interfere with the HbA1c measurement, meaning the device's reading should remain accurate despite the variant's presence.

8. The Sample Size for the Training Set

This information is not provided in the summary. This device is an in vitro diagnostic (IVD) kit using high-performance liquid chromatography (HPLC) and associated software. While software might undergo internal development and validation (which could involve "training" in a broad sense, especially for algorithms identifying peaks), the concept of a "training set" as it applies to machine learning or AI models is not directly relevant or typically disclosed for this type of IVD device in a 510(k) summary. The summary focuses on comparing the new software's performance against the old, representing an update to an established analytical method.

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

As noted above, a "training set" in the context of AI/ML is not directly applicable. If one considers the development of the analytical method and software, the ground truth for establishing parameters would have been derived from extensive analytical chemistry principles and experiments, likely involving reference methods and characterized samples to ensure accurate chromatographic separation and calculation of HbA1c. This foundational work would be part of the product's overall development, not explicitly detailed as a "training set" in this 510(k) summary.

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