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The S-Test Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum or heparin plasma using the S40 Clinical Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test High Density Lipoprotein Reagent is intended for the quantitative determination of HDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum or heparin plasma using the S40 Clinical Analyzer. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Cholesterol (CHO), S-Test HDL Cholesterol (HDL) and S-Test Triglycerides (TG) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of CHO, HDL, and TG concentrations in serum or heparin plasma based on a photometric test measuring the formation of reddish purple complexes in coupled enzymatic reactions.

The provided text describes the 510(k) summary for the S-Test Cholesterol (CHO), S-Test High Density Lipoprotein Cholesterol (HDL), and S-Test Triglycerides (TG) reagent cartridges for use with the S40 Clinical Analyzer. This summary outlines the performance data for each test.

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The studies described are primarily analytical performance studies conducted by Alfa Wassermann Diagnostics Technologies, LLC, both in-house and at Physician Office Laboratory (POL) sites. These studies evaluated precision, accuracy, detection limits, and matrix comparisons (serum vs. plasma).

Additional Information on the Study:

1. Sample sizes used for the test set and the data provenance:

   • S-Test CHO:

     • Accuracy (correlation study): 98 samples (range: 31 to 335 mg/dL).
     • Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
     • Serum vs. Plasma: 29 paired samples.

   • S-Test HDL:

     • Accuracy (correlation study): 94 samples (range: 15 to 116 mg/dL).
     • Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
     • Serum vs. Plasma: 36 paired samples.

   • S-Test TG:

     • Accuracy (correlation study): 87 samples (range: 24 to 584 mg/dL).
     • Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
     • Serum vs. Plasma: 30 paired samples.

   • Data Provenance: The studies were conducted by the manufacturer, Alfa Wassermann Diagnostic Technologies, LLC, both in-house ('in-house over five days') and at three separate Physician Office Laboratory (POL) sites. The text does not specify the country of origin of the data, but the 510(k) owner is based in West Caldwell, NJ, USA. The data appears to be prospective in nature, as indicated by controlled experiments like "testing three CHO levels for 22 days."

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

   • This is an analytical performance study for an in vitro diagnostic (IVD) device, not an interpretative imaging or diagnostic test requiring human expert adjudication for ground truth.
   • The "ground truth" or reference method for accuracy studies was a "comparative method (x)." The specific identity or nature of this comparative method is not detailed, but for IVDs, this typically refers to a well-established, often FDA-cleared, reference assay run on another analyzer or a gold standard method. No human experts are described as establishing ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable. This is an analytical performance study comparing the device's quantitative measurements against a comparative method. There is no human adjudication process involved as would be seen in image interpretation or clinical diagnosis studies.

4. 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 (IVD) assay, not an AI-assisted diagnostic imaging or interpretative tool. There are no human readers or AI involved in the interpretation of results in this context.

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

   • Yes, the performance data presented are for the standalone analytical performance of the S-Test reagent cartridges on the S40 Clinical Analyzer. This represents the "algorithm only" or device-only performance for quantitative measurements of cholesterol, HDL, and triglycerides. There is no mention of a human-in-the-loop component in the direct measurement process.

6. The type of ground truth used:

   • The "ground truth" for the accuracy studies was established by a "comparative method (x)." This means the new device's measurements were compared against another existing, presumably validated, method for measuring cholesterol, HDL, and triglycerides. This is a common practice for demonstrating analytical accuracy for IVD devices, comparing to a "reference standard" or "predicate device" method.

7. The sample size for the training set:

   • Not applicable. This is an analytical performance study of a reagent system, not a machine learning or AI model that requires a training set. The device's performance is characterized through experiments.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set mentioned in the context of this analytical performance study.

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The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.

The S-Test LD Reagent cartridge is intended for the quantitative in vitro diagnostic determination of LD activity in serum, used with the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases (e.g., acute viral hepatitis, cirrhosis, metastatic carcinoma of the liver), cardiac diseases (e.g., myocardial infarction), and tumors of the lung or kidneys.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Correlation coefficient: 0.9857
• Standard error estimate: 19.8
• Confidence interval slope: 0.934 to 1.008
• Confidence interval intercept: -13.3 to 2.7
  POL sites (4 sites):
• Correlation coefficients: 0.9971 to 0.9989
• Standard error estimates: 6.4 to 10.5
• Confidence interval slopes: 0.941 to 1.001
• Confidence interval intercepts: -11.1 to 11.0 |
  | Detection Limit | Low (e.g., clinically relevant lower bound) | 9 U/L |

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

• Sample Size for Accuracy Study (In-house): 81 samples
• Sample Size for Accuracy Studies (POL sites): Not explicitly stated, but implies multiple samples were tested at each of the four separate POL sites.
• Sample Size for Precision Study (In-house): Not explicitly stated how many individual measurements contributed to the CVs, but involved testing at three LD levels over 22 days.
• Sample Size for Precision Study (POL sites): Not explicitly stated, but involved testing at three separate POL sites over 5 days.
• Data Provenance: The studies were conducted "in-house" (presumably by Alfa Wassermann Diagnostic Technologies, LLC, in the US) and at "three separate Physician Office Laboratory (POL) sites" and "four separate POL sites," indicating that data was collected from various clinical settings. Given the submitter's location in New Jersey, USA, and the FDA submission, it's highly probable the data is from the United States. The studies appear to be prospective as performance specific to this device and its use with the S40 Clinical Analyzer was generated.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative biochemical measurement. The "ground truth" for the test set is established by a comparative, legally marketed method (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent), not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring a biochemical marker against a comparative method, there is no human adjudication involved in establishing the "ground truth." The comparison is a direct numerical correlation between the S-Test LD and the predicate device.

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

Not applicable. This device is an in vitro diagnostic test for quantitative determination of an analyte (LD activity). MRMC studies are typically performed for diagnostic imaging or pathology devices where human readers interpret medical images or samples.

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

Yes, this describes the primary performance evaluation. The S-Test LD Reagent cartridge, when used with the S40 Clinical Analyzer, performs the quantitative measurement of LD activity without human interpretation in the results generation. The performance data presented (precision, accuracy, detection limit) are direct technical performance characteristics of the device itself.

7. Type of Ground Truth Used

The ground truth for the performance studies was established by comparison to a legally marketed predicate device (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent) using the "comparative method." This is a common and accepted method for establishing the performance equivalence of new IVD assays.

8. Sample Size for the Training Set

Not applicable. This is a biochemical reagent and analyzer system, not a machine learning or AI-based device that requires a "training set" in the conventional sense of artificial intelligence. The device's operational parameters and calibration procedures are established through manufacturing and quality control, not through a data training pipeline.

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

Not applicable. As mentioned above, there is no "training set" for this type of IVD device in the context of machine learning. The operational characteristics and performance specifications are inherent to the chemical reactions and instrumental design, validated through standard analytical performance studies.

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The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma based on a photometric test measuring the formation of a reddish purple complex in a coupled enzymatic reaction.

1. Acceptance Criteria and Reported Device Performance:

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

• Precision Studies:
  • Main Study: Not explicitly stated, but "three LDL levels for 22 days" implies repeated measurements over time. The number of individual samples for within-run and total CV calculation would be based on these repeated measurements at each level.
  • POL Site Studies: "three separate Physician Office Laboratory (POL) sites over 5 days" at "three separate POL sites." Similar to the main study, number of individual samples would be based on repeated measurements at each POL site.
• Accuracy (Correlation Study): 110 serum samples with LDL values ranging from 11 to 388 mg/dL.
• Matrix Comparison (Serum vs. Plasma): 34 paired samples drawn from the same patients.
• Data Provenance: The document does not explicitly state the country of origin for the data. Given the submission is to the FDA, it is likely the studies were conducted in the US or in a manner compliant with US regulatory standards. The studies appear to be prospective in nature, as they involve performing tests on samples to evaluate device performance.

3. Number of Experts and Qualifications for Ground Truth:

The document describes performance studies comparing the S-Test LDL reagent to a "comparative method" or a "predicate device" (Alfa Wassermann ACE plus ISE/Clinical Chemistry System with ACE Low Density Lipoprotein Cholesterol Reagent K991733).

• Number of Experts: Not applicable. The ground truth for this type of IVD device is typically established by another established, validated reference method or device, rather than by human expert consensus or interpretation of images.
• Qualifications of Experts: Not applicable. The "ground truth" is analytical results from an established comparative method or predicate device.

4. Adjudication Method for the Test Set:

Not applicable. The reported studies are analytical performance studies for an in vitro diagnostic (IVD) device, not studies involving human interpretation or adjudication. The "adjudication" is essentially the direct comparison of quantitative results between the candidate device and a comparative method using statistical analysis (e.g., least-squares regression, t-test).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret outputs (e.g., medical images). The S-Test LDL Cholesterol Reagent is an automated in vitro diagnostic assay that provides a quantitative numerical result, not an image or output requiring human interpretation in the context of a "reader."

6. Standalone (Algorithm Only) Performance:

Yes, the studies described are standalone performance studies of the S-Test LDL Reagent used with the S40 Clinical Analyzer. The purpose is to demonstrate the analytical performance of the device itself (reagent and analyzer system) without human diagnostic interpretation being a variable in the performance assessment.

7. Type of Ground Truth Used:

The ground truth used was analytical measurements obtained from a comparative method or predicate device. This is a common approach for establishing the accuracy of new in vitro diagnostic assays by correlating their results with those of an already accepted and validated method.

8. Sample Size for the Training Set:

The document does not provide information on a "training set" in the context of machine learning or AI models. This device is a traditional in vitro diagnostic reagent and analyzer system, not an AI-powered device that requires training data. The studies described are for analytical validation.

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

Not applicable, as there is no mention of a training set or AI model development in the provided text.

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The S-Test Creatinine Reagent is intended for the quantitative determination of Creatinine concentration in serum or heparin plasma using the S40 Clinical Analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Creatinine (CRE) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CRE in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple pigment in a coupled enzymatic reaction.

The provided document describes the performance data for the S-Test CRE Reagent, a device for quantitative in vitro diagnostic determination of Creatinine in serum or heparin plasma.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate section with numerical targets. Instead, it presents performance data for precision, accuracy, and sensitivity, implying these are the metrics against which the device's performance is judged for substantial equivalence to a predicate device.

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

• Test Set Sample Size:
  • Precision (in-house): Not explicitly stated as a number of samples, but "three CRE levels for 22 days" implies multiple measurements at each level.
  • Precision (POL): Not explicitly stated as a number of samples, but "three separate Physician Office Laboratory (POL) sites and in-house over five days" implies multiple measurements at each site.
  • Accuracy (in-house correlation): 65 samples.
  • Accuracy (POL correlation): Not explicitly stated as the number of samples per site, but implies multiple samples were tested at "four separate POL sites."
• Data Provenance:
  • The studies were conducted in-house by Alfa Wassermann Diagnostic Technology, LLC, and at Physician Office Laboratory (POL) sites.
  • The data appears to be prospective, as it describes the conduct of new studies for the purpose of demonstrating the device's performance. The nature of the "comparative method" used for accuracy also suggests a controlled test.
  • The country of origin is implicitly the United States, given the submission to the FDA.

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

This information is not provided in the document. For an in vitro diagnostic device like Creatinine, the "ground truth" for accuracy studies is typically established by a recognized reference method or a well-established comparative method, not by individual experts or their consensus. The document explicitly states "a comparative method (x)" was used. The qualifications of the personnel operating this comparative method are not detailed.

4. Adjudication Method for the Test Set:

This information is not applicable to this type of device and study. Adjudication methods (like 2+1 or 3+1) are typically used for qualitative or subjective assessments (e.g., image interpretation) where there might be disagreement among reviewers, requiring a process to establish a consensus ground truth. For quantitative assays like Creatinine, the "truth" is derived from a measurement device (the comparative method) rather than expert opinion 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:

This information is not applicable. An MRMC study is relevant for devices involving human interpretation (e.g., radiologists reading medical images). The S-Test CRE Reagent is an automated in vitro diagnostic assay for chemical analysis; it does not involve human "readers" in the context of interpretation that would be augmented by AI.

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

Yes, a standalone performance study was done. The entire performance data section describes the analytical performance of the S-Test CRE Reagent and S40 Clinical Analyzer system operating independently, determining Creatinine levels. There's no mention of a human "in-the-loop" influencing the results of the assay itself. The results reported (precision, accuracy, sensitivity) are inherent to the device's analytical function.

7. The Type of Ground Truth Used:

The ground truth for the accuracy studies (correlation) was established by a comparative method. The document refers to "a comparative method (x)" against which the S-Test CRE (y) was evaluated. This implies an independent, generally accepted analytical method for Creatinine measurement was used as the reference standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

This information is not provided or applicable in the context described. The S-Test CRE Reagent is a chemical assay, not an AI/ML-based algorithm that would typically require a distinct "training set" to develop. The performance studies described are for validation/testing of the established reagent formulation and analytical method.

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

This information is not applicable as there is no mention or indication of a training set as understood in the context of AI/ML or complex analytical model development. The development of a chemical reagent involves formulation and optimization, followed by validation studies against established methods to demonstrate performance. The "ground truth" for developing such a reagent would be derived from the fundamental chemical principles and established analytical standards for Creatinine measurement, not from a distinct "training set" with established ground truth labels.

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ACE® Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (umol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A 1 c using the ACE clinical chemistry system. This test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.

The umol HbA1c and total hemoglobin (THb) values generated are intended for use in the calculation of the HbA1c/THb ratio and cannot be used individually for diagnostic purposes.

Hemoglobin A1c Calibrators are intended for use in the performance of both a multi-point calibration for hemoglobin A1c and a single-point calibration of total hemoglobin on the ACE® clinical chemistry system, for the quantitative determination of percent (%) hemoglobin A1c in whole blood. For in vitro diagnostic use only.

Hemoglobin Alc Controls are intended to reliably monitor the accuracy and precision of quantitative determinations of hemoglobin A1c on the ACE® clinical chemistry system. For in vitro diagnostic use only,

ACE® Hemoglobin A1c (HbA1c) Reagent is provided as a single kit and consists of four bottles containing a hemoglobin denaturant, a total hemoglobin reagent, a HbAlc agglutinator reagent and a HbA1c antibody reagent.

The ACE Hemoglobin Alc Calibrators are provided as a single kit and contain ready-to-use liquid calibrators, one of each of six levels.

The ACE Hemoglobin A1c Controls are provided as a single kit and contain lyophilized controls with normal and elevated levels of HbA1c and a reconstitution fluid. The controls are prepared from human whole blood, which has been tested and found negative for antibody to Human Immunodeficiency Virus (anti-HIV) Types 1 and 2, antibody to Hepatitis C (anti-HCV) and for Hepatitis B Surface Antigen (HBsAg) by FDA recommended (approved/licensed) tests.

The document, K063306, describes the Alfa Wassermann, Inc. ACE® Hemoglobin A1c Reagent, Hemoglobin A1c Calibrators and Hemoglobin A1c Controls device. This device is intended for the quantitative determination of hemoglobin A1c and total hemoglobin in human EDTA whole blood for the calculation of percent hemoglobin A1c using the ACE clinical chemistry system.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. However, it presents performance data against which the device's efficacy can be judged, particularly in comparison to a predicate device. The implied acceptance is that the device's performance metrics are comparable to or within acceptable limits relative to established methods, as evidenced by successful correlation and precision studies.

• Regression Equation: y = 1.052x + 0.23
• Correlation Coefficient: 0.975
• Standard Error of the Estimate: 0.49
• Confidence Interval Slope: 1.000 to 1.104
• Confidence Interval Intercept: -0.20 to 0.67
  POL Labs (n=20 samples per lab):
• Lab A: y = 0.940x + 0.41, R=0.9762, SEE=0.46, CI Slp=0.871-1.009, CI Int=-0.16-0.99
• Lab B: y = 1.102x - 0.04, R=0.9818, SEE=0.47, CI Slp=1.032-1.172, CI Int=-0.63-0.55
• Lab C: y = 1.035x + 0.38, R=0.9844, SEE=0.41, CI Slp=0.974-1.095, CI Int=-0.89-0.13 |

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

• Precision Studies:
  • Main Study: For the ACE clinical chemistry system, two patient samples (one normal, one elevated) were used for determining within-run and total CVs. The number of replicates or days for this specific part is not explicitly stated, but it followed CLSI/NCCLS EP5-A2 which outlines such protocols.
  • POL Sites: Three EDTA whole blood samples with varying HbA1c levels were run in triplicate on five different days at each of the three POL sites.
• Measuring Range Study: One whole blood sample was used, which was serially diluted.
• Accuracy (Correlation) Studies:
  • Main Correlation Study: The document does not specify the exact number of samples for the main correlation study against the Tosoh Bioscience's A1c 2.2 Plus Automated Glycohemoglobin Assay. It refers to "patient samples" but no count.
  • POL Labs: Each of the three POL labs ran 20 EDTA whole blood samples in duplicate in four different runs (total of 80 measurements per lab, 240 measurements across all POL labs for accuracy comparison).
• Data Provenance: The document does not explicitly state the country of origin for the data. Given the submitter's address (West Caldwell, NJ, USA) and FDA submission context, it is highly probable the data was gathered in the United States. The studies appear to be prospective in nature, designed specifically for this submission.

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

• For this type of in-vitro diagnostic device (quantitative measurement of a biomarker), "experts" in the sense of human readers (like radiologists) are not typically used to establish ground truth.
• The ground truth is established by a predicate device or reference method, which is considered the gold standard. In this case, the Tosoh Bioscience's A1c 2.2 Plus Automated Glycohemoglobin Assay was used as the predicate device against which the accuracy of the ACE Hemoglobin A1c kit was evaluated. The performance characteristics of the predicate device are the "ground truth" here.
• There is no mention of a specific number of human experts or their qualifications for establishing ground truth, as the ground truth itself is an established laboratory method.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are common in studies where human interpretation or subjective assessment plays a role in establishing ground truth (e.g., image-based diagnostics).
• For a quantitative in-vitro diagnostic device like the ACE Hemoglobin A1c kit, which relies on chemical reactions and automated measurement, adjudication by human experts is not applicable or performed. The "adjudication" is inherent in the direct comparison of the device's quantitative output against the quantitative output of the predicate device. Discrepancies are handled through statistical analysis (e.g., linear regression, correlation).

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

• No, an MRMC comparative effectiveness study was not done.
• MRMC studies are typically used to assess the impact of an AI system (or new diagnostic tool) on human reader performance, especially in fields like radiology where human interpretation of images is critical.
• This device is an automated, in-vitro diagnostic assay for a chemical biomarker (HbA1c). Its primary function is to provide a quantitative measurement, not to assist human interpretation in a comparative effectiveness study setting.

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

• Yes, this entire study is essentially a standalone performance study.
• The ACE Hemoglobin A1c kit, when used with the ACE clinical chemistry system, operates as an automated system. The performance data presented (precision, measuring range, accuracy against a predicate) represents the performance of the algorithm/reagent system on its own, without human intervention influencing the measurement outcome once the process is initiated. Personnel (even those without formal medical technology education in POL sites) are involved in sample preparation and loading, but the actual analytical measurement and calculation are automated by the device.

7. Type of Ground Truth Used

• The ground truth used for the accuracy studies was the concurrent measurement obtained from a legally marketed and established predicate device: the Tosoh Bioscience's A1c 2.2 Plus Automated Glycohemoglobin Assay. This is a common and accepted method for establishing accuracy for new in-vitro diagnostic devices. It operates as a "reference method" in this context.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set sample size. This device is a reagent/assay kit for a clinical chemistry system, not a machine learning or AI algorithm that typically goes through a distinct "training phase" on a dataset in the same way.
• The methods described (latex agglutination inhibition assay, conversion to alkaline hematin, measurement of absorbance) are biochemical principles. While there might have been internal development/optimization data, it's not described as a formal "training set" in the context of this 510(k) summary. The calibration procedure itself (using calibrators) is a form of "training" the system for accurate measurements, but this is distinct from a dataset used for training an AI model.

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

• As concluded in point 8, a formal "training set" in the AI sense is not described.
• For the calibration process (which could be considered analogous to a system's "learning" or setting up its operational parameters), the Hemoglobin A1c Calibrators are used. These calibrators are presumably manufactured with known, precise concentrations of HbA1c and total hemoglobin, established through rigorous manufacturing and quality control standards. The ground truth for these calibrators would be established through a combination of gravimetric/volumetric preparation and validation against higher-order reference methods and materials (e.g., IFCC reference methods for HbA1c primary calibration). However, this specific process for the calibrators' ground truth is not detailed in this 510(k) summary.

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