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The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol, non-HDL cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

For use in clinical laboratories and point of care laboratory settings.

For prescription use only.

Afinion™ Lipid Panel is a fully automated assay for quantitative determination of Chol. HDL and Trig in serum. LDL, non- HDL and Chol/HDL are calculated by the Afinion™ AS100 Analyzer.

The Afinion™ Lipid Panel Test Cartridge contains all reagents necessary for determination of Chol, HDL and Trig in serum. The sampling device integrated in the test cartridge is filled with sample material. The test cartridge is then placed in the Afinion™ AS100 Analyzer. The analyzer inspects the sampling device, and the sample is then diluted.

Total Cholesterol (Chol) is measured by an enzymatic colorimetric method.
Triglycerides (Trig) are measured by an enzymatic colorimetric method.
HDL cholesterol is measured by an enzymatic colorimetric method with direct determination of HDL by initial antibody blocking of apolipoprotein B (apo-B).
LDL cholesterol is calculated by use of the Friedwald formula: LDL (mg/dL) = Chol - HDL - Trig/5.
non-HDL cholesterol is calculated as total cholesterol minus HDL: non-HDL = Chol - HDL.
Chol/HDL ratio is calculated as Total Cholesterol/ HDL Cholesterol.

Acceptance Criteria and Device Performance for Afinion™ Lipid Panel

This document outlines the acceptance criteria and the study that demonstrates the Afinion™ Lipid Panel's performance, as derived from the provided 510(k) summary (K132031).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for bias, precision (repeatability and within-device), or linearity. Instead, it presents the results of these studies and implies that these results were considered acceptable for demonstrating substantial equivalence to predicate devices. The reported device performance based on acceptable outcomes from comparison studies is presented below.

Interference: No significant interference (<10%) was observed from 26 common substances at specified concentrations. Limitations were noted for Calcium dobesilate, Methyldopa, Acetylcysteine, and Levodopa at certain levels.

Reporting Ranges (supported by linearity and LoQ studies):

Accuracy (Method Comparison with Predicate Devices):

Bias at Medical Decision Levels (Implied Acceptance: Low Bias):

Precision (Repeatability and Within-device %CV - Implied Acceptance: Low %CV):

Precision results are presented for control samples at two levels and one serum sample across three sites. The Coefficients of Variation (CV%) are generally low, indicating good precision. For example:

• Total Cholesterol: Repeatability CVs range from 1.7% to 3.5%, Within-device CVs range from 2.3% to 3.9%.
• HDL Cholesterol: Repeatability CVs range from 2.1% to 3.9%, Within-device CVs range from 2.6% to 4.9%.
• Triglycerides: Repeatability CVs range from 1.8% to 4.4%, Within-device CVs range from 2.2% to 4.9%.

2. Sample Sizes and Data Provenance

• Linearity Testing:

  • Test Set Sample Size: 11 concentration levels for each analyte, produced by intermixing one low and one high serum sample. Each level was measured in 4-6 replicates.
  • Data Provenance: Not explicitly stated, but the studies were performed by the manufacturer, Axis-Shield PoC AS (located in Oslo, Norway). The samples were described as "serum samples." It's retrospective in the sense that it's test data generated for regulatory submission, but the samples themselves could have been collected prospectively or retrospectively.

• Limits of Quantitation (LoQ) Testing:

  • Test Set Sample Size: 5 samples with concentrations near 0 mg/dL (LoB samples) and 5 low concentration samples (LoD samples). Each sample was measured in a total of 60 replicates (likely 12 replicates per sample, using 3 analyzers and 2 test cartridge lots).
  • Data Provenance: Not explicitly stated, but performed by the manufacturer. "Serum" is the sample type.

• Analytical Specificity (Interference) Testing:

  • Test Set Sample Size: "Samples covering two medical decision concentrations of each lipid analyte" were measured.
  • Data Provenance: Not explicitly stated, but performed by the manufacturer.

• Accuracy (Method Comparison) Testing:

  • Test Set Sample Size:
    • Cholesterol: 348 samples
    • Triglycerides: 246 samples
    • HDL: 251 samples
  • Data Provenance: The study was "performed at four point-of-care sites." No specific country of origin is mentioned, but the manufacturer is based in Norway. The samples were "serum." The nature of sample collection (retrospective or prospective) is not specified.

• Precision Testing:

  • Test Set Sample Size: Two control samples and one serum sample were tested. For each sample, 80 replicates were performed at each of the three point-of-care sites (2 replicates per run, 2 runs per day for 20 days).
  • Data Provenance: "Performed at three point-of-care sites." The origin of the control and serum samples is not detailed, but the study was conducted by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth

This device is an in vitro diagnostic (IVD) for quantitative determination of analytes in serum. The ground truth for such devices is established by reference methods or highly accurate laboratory methods, not by expert interpretation of images or clinical assessments.

• Traceability:
  • Cholesterol (Chol) and HDL are traceable to the National Reference System for Cholesterol (NRS/CHOL).
  • Triglycerides (Trig) are traceable to a Centers for Disease Control and Prevention (CDC) reference method.
  • The device is CRMLN certified for Total Cholesterol and HDL Cholesterol, indicating its accuracy against reference measurement procedures.

Therefore, "experts" in the traditional sense (e.g., radiologists) are not used to establish ground truth for this type of device. The ground truth is established by recognized reference standards and methods in clinical chemistry.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments (e.g., image reading). This is a quantitative diagnostic device, and the ground truth is established by objective, highly accurate reference methods or laboratory instruments. Therefore, no "adjudication method" in this context is applicable or described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting complex data (e.g., medical images). The Afinion™ Lipid Panel is a standalone quantitative measurement device, not an AI-assisted human reading system.

6. Standalone Performance Done

Yes, a standalone performance study was done. The studies detailed (linearity, limits of quantitation, analytical specificity, accuracy/method comparison, and precision) all represent the performance of the Afinion™ Lipid Panel device (algorithm only, without human-in-the-loop performance) in measuring lipid levels in serum samples.

7. Type of Ground Truth Used

The ground truth used is based on:

• Reference Methods: Specifically, the National Reference System for Cholesterol (NRS/CHOL) for Total Cholesterol and HDL Cholesterol, and a CDC reference method for Triglycerides.
• Comparison to Predicate Devices/Automated Laboratory Methods (CM): For accuracy evaluation, the Afinion™ Lipid Panel's results were compared against an "automated laboratory method (CM)" for Chol, Trig, and HDL, which are themselves established and validated lab instruments.

8. Sample Size for the Training Set

This document describes a 510(k) submission for an in vitro diagnostic device that measures specific analytes. It is highly unlikely that this device uses machine learning or AI models that require a "training set" in the conventional sense (i.e., iterative learning from labeled data). The device's operation is based on established enzymatic colorimetric methods and pre-programmed algorithms. Therefore, a "training set" size is not applicable or stated in this context.

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

As stated in point 8, a "training set" as understood in machine learning is not applicable to this type of IVD device. The methods for establishing the device's accuracy and performance are described under "Traceability" and "Accuracy" (method comparison with reference and predicate methods).

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Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Data Connectivity Converter (ADCC) is a small device for automatic transfer of data. including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system or another electronic journal system.

Afinion™ AS100 Analyzer System, consisting of Afinion™ AS100 Analyzer with Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only.

Afinion™ HbAIc is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin Alc. % HbA Ic) in human whole blood. The measurement of % HbA Ic is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

Afinion™ HbA Ic Controls have been designed for use with the Afinion™ ASI00 Analyzer System. Quality control using the Afinion™ HbA Ic Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable result.

The Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine using the Afinion™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

The Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Afinion™ ASI00 Analyzer System is working properly and provides reliable results.

The Afinion™ AS100 Analyzer is equipped with a new component/accessory: A finion™ Data Connectivity Converter (ADCC). The ADCC is only for use together with the Afinion™ AS100 Analyzer.

The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system (LIS) or another electronic journal system. It converts the format of the results from the proprietary Afinion™ Analyzer protocol to a standardized protocol (HL7 or ASTM). The main functionality for software contained in the Afinion™ Data Connectivity Converter is to:

• . Extract test result data from the Afinion™A$100 Analyzer
• . Convert the transmission format to a configurable standard protocol and forward the result data on Ethernet
• Provide user feedback on LEDs .
• Provide user interface for configuration and software upgrade through a web . interface
• Provide functionality to reset device to default/factory software status. .

The provided document describes a Special 510(k) Summary for a modification to the Afinion™ AS100 Analyzer, specifically the addition of the Afinion™ Data Connectivity Converter (ADCC). This document focuses on the safety and efficacy of the ADCC and its integration with the existing cleared device.

Crucially, the document does not contain acceptance criteria, reported device performance data, or detailed study results for the ADCC's performance in terms of diagnostic accuracy or clinical effectiveness. The study information provided is limited to design control activities and compliance with electrical and electromagnetic compatibility (EMC) standards.

Therefore, many of the requested sections below cannot be populated with information from the provided text.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for the ADCC. The acceptance criteria mentioned are related to successful completion of design control activities and compliance with safety and EMC standards.
• Reported Device Performance: The document confirms the ADCC was tested and found to be in conformity with various electrical safety and EMC standards. It does not report performance data like data transfer speed, error rates, or successful connection rates, which would be typical performance metrics for a data connectivity device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not describe a clinical "test set" or diagnostic performance study for the ADCC. The testing mentioned refers to engineering verification and validation activities (software testing, electrical safety, EMC). Therefore, no sample size or data provenance is provided for a diagnostic test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The document does not describe a study involving expert-established ground truth for a diagnostic test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. The document does not describe a diagnostic test set 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 not an AI-assisted diagnostic device, but a data connectivity converter for an existing IVD analyzer. No MRMC study was conducted or is relevant.

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

• Not applicable for diagnostic performance. While the ADCC itself functions automatically to transfer data, its "standalone performance" is described in terms of its technical functionality (extracting, converting, forwarding data) and compliance with relevant technical and safety standards, not diagnostic accuracy.

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

• Not applicable for diagnostic performance. For the engineering tests mentioned, the "ground truth" would be adherence to specified technical requirements and industry standards.

8. The sample size for the training set

• Not applicable. This document pertains to a hardware and software accessory for data transfer, not a machine learning or AI algorithm development that would involve a "training set" in the conventional sense.

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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Afinion™ ACR is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine. The measurement of urine albumin, creatinine and albumin/creatinine ratio aids in the early diagnosis of nephropathy.

Afinion™ ACR Control is a assayed in vitro diagnostic quality control material used to confirm that the Afinion™ ACR and the Afinion™ AS100 Analyzer System is working properly and provides reliable results

The Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine using the Afinion™ AS100 Analyzer. The measure of urine albumin aids in the early diagnosis of nephropathy.

The Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

Afinion™ ACR is a fully automated assay for determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine.

The Afinion™ ACR Test Cartridge contains all the reagents necessary for determining albumin, creatinine and ACR in a human urine sample. The sample material is sampled using the sampling device integrated into the Test Cartridge.

Albumin is quantified using a solid phase immunochemical assay. In the Afinion™ ACR Test Cartridge the sample is automatically diluted and aspirated through a membrane coated with antialbumin antibodies, which concentrates and immobilizes the albumin from the sample. A goldantibody conjugate then binds to the immobilized albumin resulting in a red-brown stained membrane. Excess gold-antibody conjugate is removed in a washing step. The Afinion™ AS100 Analyzer measures the color intensity of the membrane, which is proportional to the amount of albumin in the sample.

Creatinine is quantified using an enzymatic colorimetric test that involves four enzymatic steps. The test requires incubation with two distinct enzyme solutions. A colored end product is measured in one of the cartridge wells.

The concentration of albumin, the concentration of creatinine, and the calculated albumin/creatinine ratio are displayed on the Afinion™ AS100 Analyzer.

Acceptance Criteria and Study Details for Afinion™ ACR

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Afinion™ ACR assay were implicitly established through its comparison to a legally marketed predicate device, the DCA 2000® Microalbumin/Creatinine assay (K963142). The goal was to demonstrate "substantial equivalence" in performance. While explicit numerical acceptance criteria were not provided in terms of thresholds for correlation coefficients or precision values, the reported device performance, demonstrating strong correlation and acceptable precision, was considered sufficient to meet the equivalence standard.

2. Sample Size and Data Provenance

• Test Set (Method Comparison - External Study):

  • Sample Size: 169 urine samples
  • Data Provenance: Studies were conducted at "four external study sites." The specific country of origin is not explicitly stated, but the submission is from Norway, hence it's likely European or international. The samples were retrospective, as they were "analyzed" with both devices.

• Test Set (Method Comparison - Internal Study):

  • Sample Size: 91 urine samples for Albumin and ACR, 95 urine samples for Creatinine.
  • Data Provenance: "Internal method comparison study," implying the data originated from the manufacturer's own facilities. These were retrospective samples.

• Test Set (Precision Study):

  • Sample Size: Not explicitly stated as a number of unique patient samples for the clinical precision study. Instead, it refers to "two levels of urine samples" (Sample 1 and Sample 2) run multiple times. For the control precision, controls were run in "6 replicates each day over 5 operating days."
  • Data Provenance: "External precision study" and "3 study sites" for controls.

3. Number of Experts and Qualifications for Ground Truth

The study relies on comparing the performance of the new device against a predicate device (DCA 2000® Microalbumin/Creatinine assay). Therefore, the "ground truth" for the test set is effectively the result obtained from the predicate device. No human experts were used to establish a separate, independent ground truth for the test samples in this specific type of comparison study. The predicate device itself acts as the reference standard.

4. Adjudication Method

Not applicable. Since the ground truth for comparison was the result from a predicate device, and the study focused on quantitative correlation and precision, there was no need for expert adjudication of results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for an in vitro diagnostic (IVD) device, specifically an automated assay for quantitative measurement. This type of study is more common for imaging devices or those requiring human interpretation of results. The study design focuses on the analytical performance (accuracy, precision) of the device itself compared to a predicate device, not on how human readers' diagnostic performance might improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the study describes the standalone performance of the Afinion™ ACR assay. It is an "automated assay" that "quantifies" albumin and creatinine, and "calculates" the ACR. The performance metrics (correlation coefficients, precision) presented are solely based on the device's measurements from urine samples, without human intervention in the result generation or interpretation to modify the output.

7. Type of Ground Truth Used

The "ground truth" used for evaluating the Afinion™ ACR assay was the results obtained from a legally marketed predicate device, the DCA 2000® Microalbumin/Creatinine assay (K963142). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It relies on the established accuracy and reliability of the predicate.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size in the context of device development. For IVD assays, development often involves extensive internal testing, calibration, and optimization using various samples, but this is usually distinct from the formal "training set" concept seen in AI/machine learning development.

9. How Ground Truth for the Training Set was Established

Given that this is an in vitro diagnostic assay and not a machine learning algorithm in the typical sense, there isn't a "training set" with ground truth established in the way one would for an AI model.

The "standardization" section states that:

• Albumin is calibrated against the ERM®-DA470 reference preparation.
• Creatinine is calibrated against SRM 914a.

These reference materials serve as the foundational "ground truth" for the device's calibration, ensuring that its measurements are traceable to recognized international standards. This calibration process, along with extensive internal testing and optimization (which would involve numerous samples with known values, likely determined through reference methods or predicate devices), forms the basis of the device's accuracy.

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Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer Afinion™ Test Cartridges and Afinion™ Controls is for in-vitro diagnostic use only. Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of -care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate results.

Afinion™ HbA Ic is an in-vitro test for quantitative determination of glycated hemoglobin in human blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

Afinion™ HbA1c Controls have been designed for use with the Afinion™ AS100 Analyzer System. Quality control using the Afinion™ HbA 1c Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

Instrument read, single usc in-vitro test for quantitative determination of glycated hemoglobin in human whole blood.

Afinion™ AS100 Analyzer utilizes a digital camera and Light Emitting Diodes to perform two kinds of measurements; reflection mcasurement (amount of light rcflected from a membrane) and transmission measurement (amount of light propagating through a liquid). The analyzer is self-calibrated and no calibration by user is needed.

This looks like a 510(k) summary for a medical device called Afinion™ HbA1c, Afinion™ HbA1c Control, and Afinion™ AS100 Analyzer. I will extract the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally inferred from the "acceptable agreement" statements and specific thresholds mentioned for CV, linearity, and interference.

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

• Method Comparison (Internal): 40 venous EDTA blood samples. Provenance: Not explicitly stated, but "analyzed internally" suggests within the manufacturer's lab. Retrospective or prospective is not specified.
• Method Comparison (External): 75 venous EDTA blood samples. Provenance: Three external study sites. Retrospective or prospective is not specified.
• Method Comparison (vs. European Reference Laboratory): 39 venous EDTA blood samples. Provenance: European Reference Laboratory for glycohemoglobin (ERL). Retrospective or prospective is not specified.
• Capillary vs. Venous Blood: 74 donors. Provenance: "analyzed externally." Retrospective or prospective is not specified.
• Precision (Internal): Two levels of blood samples and two controls. Numbers of replicates/runs not explicitly given for total samples, but for multi-analyzer test, two blood samples were used.
• Precision (External): Three EDTA blood samples (A, B, C). Provenance: Three external study sites.
• Dilution Linearity: One high HbA1c sample mixed with a low HbA sample to create seven intermediate concentrations.
• Hb-Variant Interference: Not explicitly specified, but "studies performed according to the ERL Manufacturer Check Up Certification procedure."
• Preglycated Hb Interference: Not explicitly specified, but "Blood samples with up to 22 % preglycated hemoglobin."
• Endogenous Interfering Substances: EDTA blood samples (number not specified).
• Exogenous Interfering Substances (Drugs): EDTA blood samples (number not specified).
• Hemolysis Interference: Samples with varying degrees of hemolysis.
• Anticoagulant Comparison: 10 donors.

General Data Provenance: The studies were conducted by Axis-Shield PoC AS (Norway) and external study sites, including the European Reference Laboratory (ERL). The data is likely a mix of internally and externally generated data from Europe/US. The text does not explicitly state if the studies were retrospective or prospective, but the phrasing suggests prospective testing for most assays.

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

The document does not explicitly state the number or qualifications of experts used to establish a ground truth in the sense of a subjective expert reading/diagnosis. Instead, the ground truth for this device (an HbA1c assay) is established by:

• Reference Methods: The predicate device (Bayer DCA 2000® Hemoglobin A1c assay) and the ERL reference method (Primus CLC385), which are themselves considered established and validated laboratory methods for HbA1c. These methods have inherent analytical capabilities, not dependent on expert interpretation for individual results.
• IFCC Traceability: The device's results are traceable to the International Federation of Clinical Chemistry (IFCC) Reference Method and reported at DCCT-level via the NGSP Master Equation. This standardization provides the "true" value.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. This is an in-vitro diagnostic device that provides quantitative numerical results, not subjective interpretations requiring human adjudication. The "ground truth" is established by comparison to other analytical methods or reference standards, not by consensus among human readers.

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 assay for quantitative determination of HbA1c, not an AI system designed to assist human readers in interpreting images or data. There is no human reading component or AI assistance involved.

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

Yes, this entire submission describes standalone performance. The Afinion™ AS100 Analyzer System is a fully automated assay system ("algorithm only") that quantifies HbA1c in human whole blood. The performance studies evaluate the device's ability to accurately and precisely measure HbA1c without human intervention in the result generation, beyond sample loading and initiation.

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

The ground truth used is primarily comparison to established reference methods and predicate devices.

• Predicate Device: Bayer DCA 2000® Hemoglobin A1c assay (K951361).
• Reference Method: Primus CLC385 as used by the European Reference Laboratory for glycohemoglobin (ERL).
• International Standardization: Traceability to the IFCC Reference Method and reporting at DCCT-level via the NGSP Master Equation.
• Analytical Verification: For aspects like precision, linearity, and interference, the ground truth is against defined analytical standards and expected behaviors of known samples.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI. This is a traditional IVD device. The development and calibration of such a device would involve numerous samples, but it's not a "training set" in the AI sense. The text mentions the analyzer is "self-calibrated and no calibration by user is needed," implying built-in calibration mechanisms developed during the device's engineering, not through an explicit "training set" as with AI algorithms.

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

As there is no "training set" in the AI sense, this question is not applicable. The device's internal calibration and algorithms were likely established through engineering and analytical validation using a wide range of known HbA1c concentrations and blood samples, traceable to international standards during its development phase.

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