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510(k) Data Aggregation
(119 days)
D-10 Hemoglobin A1c Program
The D-10™ Hemoglobin A1c Program is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/ mol and NGSP %) in human whole blood using ion- exchange high-performance liquid chromatography (HPLC) on the D-10TM Hemoglobin Testing System.
Hemoglobin Alc measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
The D-10™ Hemoglobin A1c Program is intended for professional in vitro diagnostic use only.
The D-10™ Hemoglobin Testing System utilizes the principles of ion-exchange highperformance liquid chromatography (HPLC). A dual-piston, low pulsation HPLC pump and a proportioning value deliver the buffer solution to an analytical cartridge and detector. Whole blood samples undergo an automatic two step dilution process and then introduced into the analytical flow path. Pre-diluted samples are aspirated directly and introduced into the analytical flow path. Between sample injections, the sample probe is rinsed with Wash/Diluent Solution to minimize sample carryover.
A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the photometer flow cell where changes in the absorbance are measured at 415 nm and recorded as a digital chromatogram.
The software performs a reduction of raw data collected from each analysis that may indicate use of a calibration factor. A samples report and chromatogram are generated for each sample.
The D-10™ Hemoglobin A1c Program is designed to be used on the D-10™ Hemoglobin Testing System with or without a D-10 Rack Loader.
The provided text describes a 510(k) premarket notification for the D-10 Hemoglobin A1c Program. This device is an in vitro diagnostic (IVD) used for the quantitative determination of hemoglobin A1c (HbA1c) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a single table, but rather presents performance characteristics derived from various studies. Based on the "Summary of Nonclinical Performance Data" and the conclusion that "The performance criteria as stipulated by the Special Controls requirements for HbA1c systems that diagnose diabetes have clearly been met," we can infer the acceptance criteria from the reported results. The critical performance metrics for an HbA1c assay for diabetes diagnosis typically include precision (CV%), linearity, and method comparison (bias).
| Performance Characteristic | Acceptance Criteria (Inferred from successful study results and regulatory requirements) | Reported Device Performance (D-10™ Hemoglobin A1c Program) |
|---|---|---|
| Precision (NGSP %) | Typically, CV% values are expected to be low, especially at clinical decision points. (Implicitly, the results demonstrate acceptable precision as per CLSI EP05-A2 guidelines). | Total Precision (Combined Instruments): |
| Patient 1 (5.2%): 2.0% CV | ||
| Patient 2 (6.7%): 1.6% CV | ||
| Patient 3 (8.3%): 1.6% CV | ||
| Patient 4 (12.7%): 2.2% CV | ||
| Control 1 (5.6%): 1.7% CV | ||
| Control 2 (10.3%): 2.2% CV | ||
| QC 1 (5.5%): 2.0% CV | ||
| QC 2 (9.9%): 1.8% CV | ||
| QC 3 (15.4%): 2.2% CV | ||
| Precision (IFCC mmol/mol) | Similarly, low CV% values are expected. | Total Precision (Combined Instruments): |
| Patient 1 (33 mmol/mol): 3.4% CV | ||
| Patient 2 (50 mmol/mol): 2.3% CV | ||
| Patient 3 (67 mmol/mol): 2.1% CV | ||
| Patient 4 (115 mmol/mol): 2.7% CV | ||
| Control 1 (37 mmol/mol): 2.8% CV | ||
| Control 2 (89 mmol/mol): 2.7% CV | ||
| QC 1 (37 mmol/mol): 3.2% CV | ||
| QC 2 (85 mmol/mol): 2.3% CV | ||
| QC 3 (145 mmol/mol): 2.5% CV | ||
| Linearity (NGSP %) | Maximum measured difference of ±0.1% between predicted 1st and 2nd order results across the reportable range. | Linear from 3.9 – 18.8% HbA1c, with a maximum measured difference of ±0.1%. |
| Linearity (IFCC mmol/mol) | Maximum measured difference of ±1 mmol/mol across the reportable range. | Linear from 19 – 182 mmol/mol, with a maximum measured difference of ±1 mmol/mol. |
| Method Comparison (Bias vs. NGSP SRL) | Biases at clinical decision levels should be within acceptable limits for diagnostic accuracy. (Implicitly, the reported biases are considered acceptable). | Bias Estimation: |
| 5.0±0.5% HbA1c: -0.05% (-0.96% Bias) | ||
| 6.5±0.5% HbA1c: 0.00% (0.03% Bias) | ||
| 8.0±0.5% HbA1c: -0.08% (-0.98% Bias) | ||
| 12.0±1.0% HbA1c: -0.10% (-0.87% Bias) | ||
| Total Error (TE) at Decision Levels | Should be below a specified threshold (e.g., as defined by CLIA or other regulatory guidelines for HbA1c testing). | Total Error Estimation: |
| 5.0% A1c: 4.9% TE | ||
| 6.5% A1c: 3.2% TE | ||
| 8.0% A1c: 4.1% TE | ||
| 12.0% A1c: 5.2% TE | ||
| Endogenous Interference | No significant interference (defined as a ± 7% change in %HbA1c value from the control) up to stated concentrations. | No significant interference observed for Lipemia (6000 mg/dL), Conjugated bilirubin (60 mg/dL), Unconjugated bilirubin (60 mg/dL), Glucose (2000 mg/dL), Rheumatoid factor (750 IU/mL), Total protein (21 g/dL). |
| Drug Interference | No significant interference (defined as a more than ± 7% change in %HbA1c value from the control) at therapeutic levels up to stated concentrations. | No significant interference observed for 15 common drugs (e.g., Acetylcysteine, Ampicillin-Na, Ascorbic acid, Cefoxitin, etc.) at specified concentrations. |
| Cross Reactivity with Hemoglobin Derivatives | No significant interference (defined as more than a ±7% change in HbA1c value from the control) at physiological levels. | No significant interference for Acetylated Hb (up to 49 mg/dL), Carbamylated Hb (up to 3.5%), and Labile A1c (up to 6%). |
| Hemoglobin Variant Interference | Acceptable bias for common variants (HbS, C, D, E, A2) and no significant interference for HbF up to 10%. | No significant interference for HbC (≤ 40%), HbD (≤ 43%), HbS (≤ 43%), HbE (≤ 32%), HbA2 (≤ 6%), and HbF (≤ 10%). Device has significant positive interference with HbF > 10%, rendering results invalid. |
| Traceability/Standardization | Traceable to IFCC reference calibrators and NGSP certified. | Traceable to IFCC reference calibrators. NGSP certified (certification expires annually). |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Precision/Reproducibility: Four EDTA whole blood samples at target HbA1c concentrations (~5%, ~6.5%, ~8%, ~12%) and five quality control materials were used. Each sample/control was run in duplicate, in 2 runs per day, on 3 instruments for 20 days, and repeated with 3 different kit lots, yielding a total of 720 results per sample over 60 days. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective clinical samples), but it implies prospective collection for the study.
- Linearity: Low (3.9% HbA1c) and high (18.8% HbA1c) EDTA whole blood patient samples were mixed in varying ratios to create 11 sample pools. The exact number of individual patient samples generating the pools is not specified.
- Method Comparison: 128 variant-free whole blood K3 EDTA samples were evaluated. The range of HbA1c was from 3.9% to approximately 19.0% (19 to 184 mmol/mol). Data provenance is not explicitly stated for these samples, but they are referred to as "patient samples."
- Endogenous/Drug Interference & Hemoglobin Derivatives Interference: Two EDTA whole blood sample pools (low level ~6.5% HbA1c and high level ~8.0% HbA1c) were used for spiking experiments. Ten replicates of each pool with interferent and control were analyzed. The specific number of individual patient samples that formed these pools is not detailed.
- Hemoglobin Variant Study: A panel of normal and diabetic whole blood EDTA patent variant samples for HbS (n=22), HbC (n=20), HbD (n=22), HbE (n=23), HbA2 (n=20), and HbF (n=24) were used. These are patient samples with known variants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For Method Comparison: The D-10™ Hemoglobin A1c Program results were compared to "testing performed at a secondary NGSP SRL reference laboratory using a cleared HPLC-based HbA1c assay." The NGSP SRL (National Glycohemoglobin Standardization Program Secondary Reference Lab) is itself a highly qualified reference standard, implying expert oversight and standardized methods for ground truth determination, though specific human experts are not named or qualified in this document.
- For Hemoglobin Variant Study: Comparison was made to a "NGSP reference method that has been demonstrated to be free from the hemoglobin interferent." Similar to the method comparison, this relies on a standardized reference method rather than individual expert adjudication for each sample.
4. Adjudication Method for the Test Set:
Not applicable in the traditional sense of image or clinical outcome adjudication by multiple experts. The ground truth for the method comparison and variant studies was established by comparison to a standardized NGSP reference method, which inherently provides a highly controlled and validated "truth" for HbA1c measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) for laboratory use, not typically subject to human reader interpretation or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are all standalone performance evaluations of the D-10™ Hemoglobin A1c Program device. The tests, such as precision, linearity, method comparison, and interference studies, assess the analytical performance of the algorithm and hardware without human interpretation in the loop determining the HbA1c value.
7. The Type of Ground Truth Used:
The ground truth for the performance studies primarily relies on:
- Reference Methods: For method comparison and variant studies, the ground truth was established by a "secondary NGSP SRL reference laboratory using a cleared HPLC-based HbA1c assay" and an "NGSP reference method."
- Expected Values/Spiking: For precision, linearity, and interference studies, ground truth was based on preparing samples with known concentrations or by comparing to control samples without interferents.
- Consensus/Certification: The general standardization is traced to IFCC reference calibrators and NGSP certification.
8. The Sample Size for the Training Set:
This document describes premarket notification studies for an in vitro diagnostic device, not a machine learning algorithm. Therefore, there is no explicit "training set" in the context of machine learning model development. The device relies on established chemical and physical principles (ion-exchange HPLC) with programmed parameters, rather than learning from a large dataset. Calibration of the instrument is performed using calibrator materials, but this is distinct from a machine learning training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no machine learning-based training set, this question is not applicable. The device's operational parameters and calibration are based on established analytical chemistry principles and reference materials. The value assignment for the calibrator materials "were previously reviewed under 510(k) submission K031043," indicating their ground truth was established through a separate, regulated process.
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(17 days)
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
The D-10TM Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.
The Bio-Rad D-10™ Dual Program system is intended for the percent determination of hemoglobins A1c, A2 and F, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The Bio-Rad D-10™ Dual Program is intended for Professional Use Only. For in vitro diagnostic use.
Measurement of the percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus, and measurement of the percent HbA2 and HbF are effective in screening of ß—thalassemias (i.e., hereditary hemolytic anemias characterized by decreased synthesis of one or more types of abnormal hemoglobin polypeptide chains). Detection of hemoglobin variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants.
The Bio-Rad Hemoglobin Testing System is a fully automated analyzer consisting of a single module that rovides an integrated method for sample preparation, and determination of specific hemoglobins in whole blood. The Bio-Rad Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g. A2, F and A1c in whole blood). The separation is based on the principles of high performance liquid chromatography. The system can accommodate 1 to 10 samples per run using a single rack currently.
The new feature in this submission is the optional D-10 Rack Loader which will be available for use with the D-10 Hemoglobin Testing System. The D-10 Rack Loader accommodates 5 racks and automatically transports each rack into and out of the D-10 System. The D-10 Rack Loader offers continuous loading, allowing the operator to insert or remove racks during a run.
The Bio-Rad D-10 Hemoglobin Testing System with the D-10 Rack Loader demonstrates substantial equivalence to its predicate devices (D-10 Hemoglobin A1c Program and D-10 Dual Program without the Rack Loader) through method correlation and precision studies.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the demonstration of substantial equivalence to the predicate devices. The study aims to show that the new device, with the rack loader, performs as similarly as possible to the predicate devices. The reported device performance is presented as correlation and precision data against these predicate devices.
D-10 Hemoglobin A1c Program (3-minute run):
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9950, Slope = 0.9415, Intercept = 0.2714 |
| Precision | Similar %CVs to Predicate | See detailed table below |
D-10 Dual Program (6.5-minute run) - HbA1c:
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9956, Slope = 0.9827, Intercept = 0.1208 |
| Precision | Similar %CVs to Predicate | See detailed table below |
D-10 Dual Program (6.5-minute run) - HbA2:
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9975, Slope = 0.9902, Intercept = 0.2476 |
| Precision | Similar %CVs to Predicate | See detailed table below |
D-10 Dual Program (6.5-minute run) - HbF:
| Metric | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Accuracy | High Correlation to Predicate (r² close to 1, slope close to 1, intercept close to 0) | r² = 0.9956, Slope = 1.0188, Intercept = -0.3863 |
| Precision | Similar %CVs to Predicate | See detailed table below |
Detailed Precision Tables (New Device with Rack Loader vs. Predicate without Rack Loader):
D-10 HbA1c Program (3 minute):
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Normal Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 5.6 | 5.9 |
| Within run (%CV) | 0.6 | 0.8 |
| Total Precision (%CV) | 1.5 | 1.8 |
| Diabetic Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 11.0 | 13.1 |
| Within run (%CV) | 0.6 | 0.3 |
| Total Precision (%CV) | 1.4 | 0.9 |
D-10 Dual Program (6.5 minutes) HbA1c:
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Normal Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 5.5 | 5.9 |
| Within run (%CV) | 0.7 | 0.8 |
| Total Precision (%CV) | 1.5 | 1.8 |
| Diabetic Sample | ||
| n= | 400 | 80 |
| Mean (%HbA1c) | 10.6 | 13.1 |
| Within run (%CV) | 0.4 | 0.3 |
| Total Precision (%CV) | 1.2 | 0.9 |
D-10 Dual Program (6.5 minutes) HbA2:
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Low Sample | ||
| n= | 400 | 80 |
| Mean (%HbA2) | 2.9 | 2.2 |
| Within run (%CV) | 1.8 | 4.5 |
| Total Precision (%CV) | 3.6 | 5.3 |
| High Sample | ||
| n= | 400 | 80 |
| Mean (%HbA2) | 4.9 | 5.4 |
| Within run (%CV) | 1.2 | 1.7 |
| Total Precision (%CV) | 3.6 | 3.1 |
D-10 Dual Program (6.5 minutes) HbF:
| New Device (with Rack Loader) | Predicate (without Rack Loader) | |
|---|---|---|
| Low Sample | ||
| n= | 400 | 80 |
| Mean (%HbF) | 1.4 | 2.1 |
| Within run (%CV) | 2.1 | 1.7 |
| Total Precision (%CV) | 2.9 | 3.3 |
| High Sample | ||
| n= | 400 | 80 |
| Mean (%HbF) | 6.6 | 8.7 |
| Within run (%CV) | 0.8 | 1.4 |
| Total Precision (%CV) | 1.8 | 2.0 |
2. Sample sizes used for the test set and the data provenance:
-
Accuracy (Method Correlation) Test Sets:
- D-10 HbA1c Program: 40 EDTA whole blood samples.
- D-10 Dual Program (HbA1c): 40 EDTA whole blood samples.
- D-10 Dual Program (HbA2): 39 EDTA whole blood samples.
- D-10 Dual Program (HbF): 39 EDTA whole blood samples.
- Data Provenance: The document does not specify the country of origin of the data. It implies the samples are human anticoagulated whole blood (EDTA) and patient samples (normal and diabetic, low and high concentration for HbA2 and HbF). The study appears to be an internal validation study and implicitly prospective for the "new device" performance, as it compares it concurrently to the "predicate device" performance using the same samples where appropriate for method correlation.
-
Precision Test Sets:
- For the new device (with D-10 Rack Loader), for each analyte (HbA1c, HbA2, HbF) and concentration level (Normal/Diabetic or Low/High), n=400 (two samples run on each of five racks, twice a day over 20 working days, with duplicate aliquots analyzed per run).
- For the predicate device (without D-10 Rack Loader), for each analyte and concentration level, n=80 (two samples run on one rack, twice a day over 20 working days, with duplicate aliquots analyzed per run).
- Data Provenance: Similar to accuracy, the country of origin is not specified. The samples are described as "EDTA whole blood patient samples." The protocol appears to be prospective for establishing precision for both the new and predicate systems under the specific test conditions. The document notes that "precision samples are different, since they were run at different time periods," indicating separate precision studies for the new and predicate configurations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in-vitro diagnostic (IVD) test for quantitative measurement of hemoglobin components. The "ground truth" for method correlation and precision studies is typically established by comparing the new device's measurements against a recognized reference method or a legally marketed predicate device (as in this case).
- The document does not mention the use of human experts (e.g., radiologists) to establish ground truth. The ground truth for this type of device is the quantitative value determined by the existing, validated methods (the predicate devices).
4. Adjudication method for the test set:
- Not applicable. This is a quantitative IVD device. "Adjudication" typically refers to resolving discrepancies between human readers or between an algorithm and human readers, often in image-based diagnostics. Here, the comparison is between two analytical methods (new device vs. predicate device).
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 is not a diagnostic imaging device involving human readers or AI assistance in interpretation. It is a fully automated analytical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the entire study pertains to the standalone performance of the Bio-Rad D-10 Hemoglobin Testing System with the D-10 Rack Loader. The device itself is an automated analyzer, meaning its performance is "algorithm only" in the sense that the measurement process is automated, without human intervention in the result generation beyond sample loading and instrument operation. The comparison is against the standalone performance of predicate automated analyzers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for evaluating the new device's performance is the measurements obtained from the existing, legally marketed predicate devices (Bio-Rad D-10 Hemoglobin A1c Program and D-10 Dual Program without the D-10 Rack Loader).
- For HbA1c, the predicate device (and by extension the new device) is traceable to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC, and certified by the National Glycohemoglobin Standardization Program (NGSP). This constitutes a high-order reference for HbA1c.
- For HbA2 and HbF, the document states, "The Joint Committee on Traceability in Laboratory Medicine has not identified a higher order reference method or reference material for the quantitation of HbA2 and HbF," implying the predicate device's established performance serves as the practical ground truth for comparison.
8. The sample size for the training set:
- This document describes performance studies (accuracy and precision) for a new version of an existing device (adding a rack loader). It does not explicitly mention a "training set" in the context of machine learning model development. For IVD devices, validation typically involves performance studies on clinical samples, rather than a separate "training" and "test" set as seen in AI/ML. The samples used for method correlation and precision testing serve as the validation data for the device's performance.
9. How the ground truth for the training set was established:
- Not applicable, as a distinct "training set" for an AI/ML model is not described in the context of this IVD device submission. The device's underlying principles (ion-exchange high performance liquid chromatography) are well-established analytical methods, not derived from machine learning. The comparison is made against the established performance of predicate devices.
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(148 days)
D-10 HEMOGLOBIN A1C
The Bio-Rad D-10 Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.
The D-10 Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is based on chromatographic separation of Hemoglobin A1c on a cation exchange cartridge.
This document describes the Bio-Rad D-10™ Hemoglobin A1c Program, a device intended for the percent determination of hemoglobin A1c in human whole blood. The submission focuses on establishing substantial equivalence to a predicate device, the VARIANT™ II Hemoglobin A1c Program.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for novel devices. Instead, it aims to demonstrate substantial equivalence to a predicate device through method correlation. Therefore, the "acceptance criteria" can be inferred as achieving excellent correlation with the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (D-10 Hemoglobin A1c Program vs. VARIANT II Hemoglobin A1c Program) |
|---|---|
| Excellent correlation between methods (slope and intercept demonstrating linearity close to y=x) | Regression Method: Least Squares |
| Slope: Not directly reported, but implied to be close to 1 given the conclusion of "excellent correlation". | |
| Intercept: Not directly reported, but implied to be close to 0 given the conclusion of "excellent correlation". | |
| (The provided regression table is corrupted and unreadable. The text states "excellent correlation".) |
2. Sample Size used for the test set and the data provenance:
- Sample Size: 40 anticoagulated whole blood samples.
- Data Provenance: Not explicitly stated but clinical samples of human whole blood. The document doesn't specify the country of origin or if it's retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic device, these samples would likely be collected specifically for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is an analytical performance study comparing two similar devices for measuring HbA1c, not a study involving expert interpretation of images or clinical outcomes. The "ground truth" for the test set samples is the measurement provided by the predicate device (VARIANT II Hemoglobin A1c Program).
4. Adjudication method for the test set:
Not applicable. This study compares quantitative measurements, not subjective assessments requiring 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:
Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI-assisted diagnostic imaging study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this is a standalone performance assessment of the D-10 Hemoglobin A1c Program against the predicate device. The device reports a quantitative value (percent HbA1c) directly.
7. The type of ground truth used:
The "ground truth" for this study is the measurement obtained from the predicate device, the VARIANT™ II Hemoglobin A1c Program. Both devices are standardized to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC, and certified via the National Glycohemoglobin Standardization Program (NGSP).
8. The sample size for the training set:
Not applicable. This device is a pre-programmed ivD based on established HPLC principles, not a machine learning or AI model that requires a training set in the typical sense. Its "training" is inherent in its design and calibration processes, which are themselves subject to standardization (DCCT, IFCC, NGSP).
9. How the ground truth for the training set was established:
Not applicable. As above, this is an analytical instrument, not an AI/ML model with a distinct training set and ground truth establishment methodology. The device's accuracy relies on its adherence to established analytical principles and standardization protocols (DCCT, IFCC, NGSP).
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