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Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood.

The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood.

For in-vitro diagnostic use only.

Hemo Control consists of the Hemo Control photometer / analyzer and the Hemo Control Hemoglobin Microcuvettes, its accessories and consumables (i.e. Control Solution Hb-con).
The Hemo Control photometer / analyzer is a semi-automated, spectrophotometric instrument, which provides instant quantitative total hemoglobin results.
Using the reagent filled microcuvette a small amount of arterial, venous or capillary blood is taken up by capillary action. The filled microcuvette is inserted into the Hemo Control photometer. The color produced by chemical reaction in the microcuvette is measured and the Hb value is displayed.
The measurement accuracy of the Hemo Control Hemoglobin Measurement System can be verified by use of Hb-con control solution, a quality control material with pre-determined hemoglobin concentration.
As a second quality control measurement, the control cuvette as a physical standard is used for a comfortable and cheap check of the device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Hemo Control device:

Device: Hemo Control (automated hemoglobin system)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents performance characteristics of the device. The reported performance is the demonstration that the device meets the implicit acceptance criteria for substantial equivalence to its predicate device. For example, the low %CV values for precision demonstrate acceptable reproducibility. The regression equations with r-values close to 1 and slopes close to 1 for method comparison studies demonstrate agreement with reference methods and predicate devices.

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

• Precision: The document provides Coefficient of Variation (CV) values for "Within Run," "Total," and "Single Observation 20 days" at low (107 g/L), normal (129 g/L), and high (173 g/L) hemoglobin concentrations. The specific number of samples or measurements for each of these precision studies is not explicitly stated in this summary, but typically, precision studies involve repeated measurements of control materials or patient samples.
• Method Comparison (NCCLS Reference Method): n = 174 samples
• Method Comparison (HemoCue hemoglobin measurement system): n = 286 samples
• Method Comparison (Hemo Control Cuvettes in HemoCue): n = 286 samples
• Matrix Comparison (Capillary samples): n = 275 samples
• Matrix Comparison (Arterial samples): n = 10 samples

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that this is a 510(k) submission from a German company (EKF-diagnostic GmbH) and involves comparison to established reference methods and other commercially available devices, it is highly likely these were prospective studies conducted in a clinical or laboratory setting.

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

This device is an automated hemoglobin system that measures a quantitative value (hemoglobin concentration). It does not rely on expert interpretation for its output. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or diagnostic classification (e.g., radiologists) is not relevant here.

The "ground truth" for method comparison studies is established by:

• NCCLS Reference Method: This refers to a standardized laboratory method (likely cyanmethemoglobin method, which is a gold standard for hemoglobin measurement). The reference method itself is the "ground truth."
• Predicate Device (HemoCue hemoglobin measurement system): This is another commercially available, cleared device that serves as a comparison standard.

4. Adjudication Method for the Test Set

Not applicable. Since the device produces a quantitative numerical output for hemoglobin concentration, there is no need for an adjudication method among experts. The "ground truth" is determined by the reference method or comparison device.

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 relevant for diagnostic devices where human readers interpret output (e.g., medical images) to assess the impact of AI assistance on their performance. The Hemo Control is an automated quantitative device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the analytical performance and method comparison studies described are inherently standalone performance studies. The Hemo Control device (photometer and microcuvettes) itself performs the measurement and provides the hemoglobin value. There is no "human-in-the-loop" interaction for interpreting the result, only for operating the device, taking the sample, and understanding the output.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation included:

• NCCLS Reference Method: A highly standardized, accepted laboratory method for hemoglobin measurement.
• Predicate Device Performance: Comparison against the performance of another legally marketed device (HemoCue hemoglobin measurement system).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device operates based on spectrophotometric principles and chemical reactions, not on complex machine learning algorithms that require large training data sets in the typical sense. The fundamental physical and chemical principles are well-established.

The studies described (precision, linearity, method comparison, matrix comparison) are typically considered verification and validation studies performed after the device design is largely finalized, not for "training" an algorithm.

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

Not applicable, as a "training set" in the machine learning sense is not mentioned or implied for this device's operation. The device's calibration and performance are established against physical standards, reference methods, and quality control materials, which form its inherent "ground truth." Specifically, the device is calibrated against the NCCLS reference method, and its accuracy can be verified using Hb-con control solutions (quality control material with pre-determined hemoglobin concentration) and a control cuvette as a physical standard.

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The Quo-Test Alc System is intended for the in vitro quantitative determination of glycated hemoglobin (%HbA1c) levels in venous whole blood samples (using K2EDTA and lithium heparin anticoagulants). Measurement of percent glycated hemoglobin (%HbA1c) is effective for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus.

The Quo-Test A1c System is not intended for screening or diagnosis of diabetes or neonatal use. The device is intended for professional use in a clinical laboratory setting.

The Quo-Test Analyzer and A1c Test Kit (Quo-Test A1c System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from venous samples. The system contains a fluorimeter and two photometers to enable both fluorescent and photometric measurements to be made. The Quo-Test A1C Assay is calibrated by the manufacturer using European Reference Laboratory (ERL) calibrators. There are no user-serviceable parts in the analyzer. It has ports to support a printer and barcode scanner plus a USB port. It is powered by an AC/DC adapter plugged into a 100-240V AC outlet. The Quo-Test A1c Test Cartridge contains all the reagents, in a plastic cuvette, required to perform an HbA1c test on the Quo-Test Analyzer. The reagents consist of a lysing agent, buffer and a boronate fluorophore conjugate. A low level of sodium azide preservative is used to enhance the shelf life of the test cartridge. Each test cartridge is for single-use. The test cartridges are supplied in individual foil pouches and should be stored at 2 - 8°C.

This document describes the premarket notification (510(k)) for the Quo-Test A1c System, a device intended for the in vitro quantitative determination of glycated hemoglobin (%HbA1c) levels in venous whole blood samples for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. A Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally implied by the performance characteristics demonstrated to be comparable (substantially equivalent) to the predicate device and compliant with relevant CLSI guidelines. While explicit "acceptance criteria" are not presented in a single table with pass/fail marks, the results provided in the analytical performance sections serve as the evidence that the criteria were met.

Here's a table summarizing the implicit acceptance criteria (based on common industry standards and the predicate device's performance, and supported by the study methodologies) and the reported performance:

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

• Precision Study (20-day precision):
  • Sample Size: Three venous blood samples (High, Medium, Low A1C) and two control solutions. Each was tested in duplicate at two separate occasions per day over twenty days.
  • Data Provenance: Internal evaluation by the manufacturer. Not specified if retrospective or prospective, but the design suggests a prospective, controlled laboratory study. Country of origin not explicitly stated for samples but manufacturer is Germany.
• Linearity Study:
  • Sample Size: 11 patient samples (mixed in incremental amounts to generate a series of 11 samples over a broad HbA1c concentration range). All samples were analyzed fivefold.
  • Data Provenance: Study carried out by Isala Ziekenhuis, Department of Clinical Chemistry, Zwolle, The Netherlands in August 2018. This was a prospective study using patient samples.
• Stability Study (Reconstituted Controls):
  • Sample Size: Three EKF A1c Control Kits, each with a Normal Control. 4 bottles of each level (Normal/Abnormal) from each lot were pooled after reconstitution.
  • Data Provenance: Internal testing (manufacturer or OEM). Prospective.
• Stability Study (Cartridges - Shelf Life):
  • Sample Size: Three blood samples (covering the relevant clinical range 5-11% A1C) and the normal and abnormal kit controls. Each of five samples measured n=3 times on each of three Quo-Test analysers at five interval time points over a 15-month period.
  • Data Provenance: Internal testing (manufacturer). Prospective, real-time study.
• Analytical Specificity (Interference):
  • Sample Size: Not explicitly stated for the number of blood samples or replicates, but the study design evaluated the effects of various interfering substances.
  • Data Provenance: Not specified, but likely internal laboratory testing.
• Analytical Specificity (Hemoglobin Variants):
  • Sample Size: Venous whole blood samples collected in K2 EDTA tubes spread across the analytical measurement range (4.6-11.6 % HbA1c) for each variant.
  • Data Provenance: Not specified, but likely internal laboratory testing.
• Method Comparison Studies:
  • Sample Size: Total of 424 subjects across three clinical sites. 423 K2EDTA venous samples and 149 heparin venous samples. 115 normal subjects (27.1%) and 308 diabetes subjects. 209 male and 215 female subjects, ranging from 21 to 89 years of age.
  • Data Provenance: Prospective study conducted at three clinical sites. IRB approval was obtained. Samples were sent to an NGSP-certified reference laboratory (Diabetes Diagnostic Laboratory, Columbia. MO). Country of origin for clinical sites/subjects is not specified, but the reference lab is in the US (Missouri).

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

The concept of "experts" as human readers/interpreters establishing ground truth, as typically seen in AI/imaging studies, does not directly apply here. This is an in vitro diagnostic (IVD) device measuring a biochemical analyte.

• Ground Truth for Analytical Performance: Established by quantitative laboratory methods and reference standards.
  • Precision/Linearity/Stability/Analytical Specificity: Ground truth is the quantitative value determined by the instrument/method under evaluation, compared against expected ranges or reference methods / defined mixtures. No human "experts" are adjudicating individual results in the sense of image interpretation.
  • Traceability: The ground truth for calibration and methods is tied to IFCC reference methods and NGSP certification, which involve a network of reference laboratories and expert committees, not individual human readers.
• Ground Truth for Method Comparison: Established by a NGSP-certified reference laboratory using the Tosoh 8 analyzer. The NGSP certification process ensures that laboratories meet stringent criteria for accuracy and precision in HbA1c measurement. This is the gold standard for HbA1c testing.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense of image interpretation or clinical diagnosis by multiple readers. The "ground truth" for the quantitative HbA1c measurements (analyte levels) is established by the NGSP-certified reference method, which is a highly standardized and validated laboratory process, not a subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is an in vitro diagnostic (IVD) device designed for direct quantitative measurement of HbA1c in blood, not an AI system assisting human readers in interpreting complex medical images or data. There are no "human readers" involved in interpreting the results of the Quo-Test A1c System in a manner that would necessitate an MRMC study.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are standalone performance evaluations of the Quo-Test A1c System itself. The device is designed to provide a quantitative HbA1c result directly from a blood sample. Its output is a numerical value (%HbA1c), which is then used by laboratory professionals or clinicians for patient management. There is no "human-in-the-loop" interaction for interpreting the device's output in the way an AI imaging algorithm might require a radiologist's review. The device performs its measurement and calculation independently.

7. The Type of Ground Truth Used

• Analytical Performance (Precision, Linearity, Stability, Analytical Specificity): The ground truth is effectively the expected value or the reference method/instrument's value for the specific analyte concentration in control materials, spiked samples, or serially diluted/mixed patient samples. For traceabilty, the ground truth is established by the IFCC reference method and NGSP-certified standards.
• Method Comparison: The ground truth for patient samples was established by an NGSP-certified reference laboratory using the Tosoh 8 analyzer, which serves as the gold standard/reference method for HbA1c measurement.

8. The Sample Size for the Training Set

Not applicable in the context of an AI/machine learning model where a "training set" is used to develop the algorithm. The Quo-Test A1c system is a biochemical assay, not an AI algorithm trained on data. Its "training" or calibration is based on manufacturer's procedures using reference calibrators traceable to international standards (NGSP/IFCC), as described in the "Calibration" section.

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

As explained above, there's no "training set" in the AI sense. For the calibration of the device and its cartridges:

• The Quo-Test A1C System is certified by the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).
• The Quo-Test Analyzer and A1C Test Cartridges have been calibrated using samples provided by the European Reference Laboratory (ERL) via the NGSP network.
• Results obtained using the Quo-Test A1C System are traceable to the IFCC reference method.

This means the ground truth for the device's calibration (which would be analogous to "training" in an ML context) is established by highly standardized and internationally recognized reference methods and laboratories.

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The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.

The DiaSpect Tm system consists of an analyzer and cuvettes. The DiaSpect Tm analyzer is a spectrophotometric instrument for the total hemoglobin concentration in unaltered human blood. The DiaSpect Tm Cuvette is injection-molded of poly methyl methacrylate (PMMA) and contains a cavity of 10 uL volume. The cavity is empty.

Here's a summary of the acceptance criteria and the study that proves the DiaSpect Tm system meets those criteria, based on the provided document:

Acceptance Criteria and Reported Device Performance

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The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.

For In Vitro Diagnostic Use Only

The Hemo-Control Hemoglobin Measurement System is comprised of a Hemo-Control Hemoglobin Measurement Photometer and Hemo-Control Microcuvettes. The scope of this 510(k) is limited to a modification of the microcuvettes.

The Hemo-Control Microcuvettes are single-use microcuvettes filled with dry reagents. A modified azide methemoglobin method is used. The use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled microcuvette is inserted into the Hemo-Control Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light.

The plastic microcuvette consists of a clear body with a cavity which takes up approximately 10 µL of blood which combines with the dry reagent chemistry. The optical distance between the microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples using the Lambert-Beers Law. The microcuvette optical and chemical characteristics are unchanged by the modification.

The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).

The provided documentation describes the acceptance criteria and a study demonstrating that the modified Hemo_Control Microcuvettes meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study primarily focuses on precision and correlation with a reference method. The acceptance criteria can be inferred from the reported precision (low CV%) and strong correlation (high R^2).

Note: The acceptance criteria are "implied" as specific numeric thresholds are not explicitly stated as "acceptance criteria" but rather as "results obtained" that demonstrate substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 100 samples
• Data Provenance: The document does not explicitly state the country of origin. The test used venous blood samples. It is a retrospective analysis in the sense that the samples were already collected and then tested. The study design appears to be a laboratory evaluation (non-clinical test).

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

This study is a non-clinical laboratory test comparing a device's performance to a reference method, not an interpretative study requiring human expert ground truth.

• Number of Experts: Not applicable, as the ground truth was established by a reference method.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison to a reference method, not an interpretative study requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a non-clinical laboratory evaluation of a modified medical device against a reference standard, not an AI-assisted diagnostic tool involving human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The precision and correlation data presented represent the performance of the modified microcuvette with the Hemo_Control device, without human interpretation as part of the measurement process. It's a "device only" performance evaluation.

7. Type of Ground Truth Used

The ground truth was established by a reference method, specifically the CLSI H15-A3 standard for the quantitative determination of hemoglobin in blood.

8. Sample Size for the Training Set

Not applicable. This device is a measurement system, and the study described is a validation study for a device modification, not a machine learning model that requires a training set. The "device" already has its algorithm embedded.

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

Not applicable, as no training set for a machine learning model was used.

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The Hemo Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3000-3011-050 are indicated for use in the Hemo Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. For In Vitro Diagnostic Use Only Caution: Federal law restricts this device to sale by or on the order of a physician.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria in the format you requested.

The document is an FDA 510(k) clearance letter for the EKF-diagnostic Hemo Control Hemoglobin Measurement System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This kind of detailed study information is typically found in the 510(k) submission itself or in scientific publications, not in the FDA's clearance letter.

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