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For the quantitative determination of percent hemoglobin A1c in whole blood (or hemolysate derived from whole blood) on Roche clinical chemistry analyzers. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

With the Tina-Quant Hemoglobin A1c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA1c by an turbidimetric inhibition immunoassay (TINIA). Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbA1c from the HbA1c/ Hb ratio according to a user selected protocol.

Here's a summary of the acceptance criteria and study information for the Tina-Quant® Hemoglobin A1c Gen.2 Test System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on modifications to an already cleared device (K052464). The acceptance criteria for the new features or extended parameters are shown below, along with the reported performance where available.

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

• Measuring Range (Integra 800/800 CTS): Not explicitly stated, but the "Measuring Range" section indicates that the extended range for Integra 800/800 CTS is now 0.3 - 3.4 g/dL HbA1c. The previous range was 0.3-2.6 g/dL. No specific sample size for the range extension study is detailed in the provided text.
• Endogenous Interferences: The criteria implicitly suggest testing with relevant concentrations of interfering substances. No specific sample size per interferent is mentioned.
• Anticoagulant (Potassium fluoride/Na2-EDTA): "Testing of ≥ 50 paired samples (i.e. serum/plasma)". The provenance of this data is "internally documented data," suggesting it was generated by Roche Diagnostics, likely in-house. It is prospective data collection for this specific evaluation.

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

This device measures a biochemical analyte (HbA1c). The "ground truth" or reference values are established through certified reference methods or calibrated devices. There are no "experts" in the human diagnostic image review sense to establish ground truth for a clinical chemistry assay like HbA1c. The assessment is based on comparison to an established reference method or predicate device performance. The text mentions "Based on study done with IFCC standardization" for expected values.

4. Adjudication Method

Not applicable. This is a quantitative chemical assay, not a subjective interpretation task requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic imaging or interpretive device that relies on human readers. Its performance is measured quantitatively against reference values.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies described are standalone performance evaluations of the assay system itself. For example, the precision, lower detection limit, endogenous interferences, and anticoagulant validation are all tests of the device's inherent analytical performance, independent of human interpretation.

7. Type of Ground Truth Used

• Measuring Range: Established by the ability of the assay to accurately quantify HbA1c within that range, likely by measuring samples with known HbA1c concentrations (e.g., control materials, spiked samples) traceable to a reference method (like IFCC).
• Endogenous Interferences: Established by comparing measurements of samples containing known concentrations of HbA1c with and without the interfering substance, using a reference method if necessary, or comparing to the predicate's performance.
• Anticoagulant: Ground truth for this would be the HbA1c values obtained from samples collected with the originally accepted anticoagulants or a reference method, against which samples collected with the new anticoagulant (potassium fluoride/Na2-EDTA) are compared. The reference values are NGSP values (National Glycohemoglobin Standardization Program), indicating traceability to a globally accepted standardization system for HbA1c.

8. Sample Size for the Training Set

Not applicable. This is a laboratory diagnostic assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a system involves the development of reagents and optimization of the assay protocol by Roche Diagnostics.

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

Not applicable, as there is no "training set" in the context of machine learning. The assay's analytical performance (linearity, accuracy, precision) is established through validation studies using reference materials and patient samples with known values. The expected values for HbA1c are based on "IFCC standardization," which provides a robust, internationally recognized reference system.

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The Tina-Quant Hemoglobin A1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin A 1c in whole blood. HbAlc results are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

With the Tina-Quant Hemoglobin A 1 c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA 1c by an turbidimetric inhibition immunoassay (TINIA). Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbA lc from the HbA 1c/ Hb ratio according to a user selected protocol.

Here's an analysis of the acceptance criteria and study information for the Tina-Quant® Hemoglobin A1c Gen.2 device, based on the provided text, categorized by your requested points:

1. Table of acceptance criteria and the reported device performance

The provided text describes a 510(k) submission for a modified device, primarily comparing its performance to a predicate device. It doesn't explicitly state "acceptance criteria" as pass/fail thresholds against a formal standard. Instead, it presents the new device's performance characteristics, implying that these are deemed acceptable given their comparison to the predicate and industry standards for such assays. The precision values are the most quantitative performance metrics provided that could be considered against implied acceptance criteria (e.g., meeting or exceeding predicate performance, or meeting typical analytical variation for HbA1c assays).

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for the precision, linearity, detection limit, or interference studies. It describes various performance characteristics derived from testing, but "sample size" in terms of number of patient specimens or analytical replicates is not provided.

• Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal analytical validation studies conducted by the manufacturer, Roche Diagnostics, based in Indianapolis, IN. The studies are prospective in nature, as they are part of the validation for a new or modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of HbA1c. The "ground truth" for analytical performance studies is typically established by reference methods or gravimetric/volumetric standards, highly controlled samples, or comparison to an established, highly accurate predicate device or method, rather than through expert consensus on qualitative interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of images or complex qualitative data (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. For a quantitative IVD assay like HbA1c, the "ground truth" is determined analytically, not through human adjudication.

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 Tina-Quant Hemoglobin A1c Gen.2 is an in vitro diagnostic assay, not an AI-powered diagnostic imaging tool or a system requiring human "readers" or human-in-the-loop performance. Therefore, an MRMC study or assessment of AI assistance on human reader improvement is irrelevant to this device.

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

Yes, this is a standalone device performance described. The performance characteristics (precision, linearity, detection limits, interferences) are measurements of the analytical performance of the automated assay system (reagents and instrument) itself, without human intervention in the measurement process (beyond sample loading and initiation). The device calculates the % HbA1c from the HbA1c/Hb ratio automatically.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document implies the use of the following types of "ground truth" for its performance studies:

• Reference methods/Standardization: The new device's "Expected values" are "Based on study done with IFCC standardization," indicating alignment with an internationally recognized reference method for HbA1c. The previous device used "in-house standardization." This indicates a shift towards a more universally accepted ground truth.
• Highly characterized control materials and calibrators: Calibrators and control materials (e.g., Precinorm HbA1c, Precipath HbA1c) are used to ensure accuracy and traceability. These materials themselves have established values, serving as a ground truth for calibration and quality control.
• Comparisons to the predicate device: The extensive comparison table indicates that the predicate device's established performance served as a benchmark, implying that its results were accepted as a form of "ground truth" for establishing substantial equivalence.

8. The sample size for the training set

This information is not provided and is generally not applicable in the same way it would be for machine learning or AI models. This device is a traditional immunoassay, not an algorithm that undergoes a "training" phase with a dataset. Its development involves chemical and assay optimization, followed by analytical validation.

9. How the ground truth for the training set was established

As noted in point 8, there is no "training set" in the context of a traditional immunoassay like this. The immunoassay itself is designed based on known biochemical principles and optimized through laboratory experiments. Its accuracy and performance are then validated using reference materials and comparative studies, not "trained" on a dataset.

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