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The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingertip. The results from this assay are intended to be used for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus.

The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Nova Allegro Analyzer: The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges, and are easily performed by non-technical personnel. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with: Two analytical bays where the single use test cartridges are analyzed, Color Touchscreen Display, Barcode Scanner, Printer, Data Export Options, Ethernet Connection, USB Port.

Nova Allegro HbA1c Assay: The Allegro HbA1c Assay is a completely automated assay for the HbA1c in human whole blood and the calculation of estimated average glucose (eAG). Nova Allegro HbA1c Test Cartridges are the key element a user interacts with to obtain the HbA1c concentration in a Capillary finger-stick whole blood sample. The main components of the Test Cartridge are the Capillary that is used to obtain the Capillary finger-stick whole blood specimen and present it to the Test Cartridge and the reaction chamber. The Test Cartridge has a barcode label with lot specific information.

The provided text describes the performance testing of the Nova Allegro HbA1c Assay and Nova Allegro Analyzer for the quantitative determination of glycated Hemoglobin A1c (HbA1c) in capillary whole blood.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance tests and their outcomes, implying that meeting these outcomes constitutes the acceptance criteria. Explicit, numerical acceptance criteria are not always stated as "acceptance criteria," but rather as the successful outcome of the test.

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

• Linearity Testing: Eleven (11) linearity specimens.
• Interference Testing: Ten (10) replicate HbA1c tests per substance on prepared hemolysate specimens. Specific number of substances tested is indicated in Table 1 (40 substances).
• Total Hemoglobin Interference Testing: Not explicitly stated, but implies multiple HGB levels were tested.
• Method Comparison: A total of 526 subjects/specimens across four clinical sites.
  • Site 1: 156 samples
  • Site 2: 154 samples
  • Site 3: 102 samples
  • Site 4: 114 samples
• Precision (20-Day Imprecision - Controls): Two control solutions, each analyzed 80 times (20 days * 2 times/day * 2 duplicates) at each of four sites.
• Repeatability (Capillary Fingerstick Blood): 524 subjects from the Method Comparison study had a second fingerstick specimen collected and measured.
• Hemoglobin Derivative and Fractions, Hemoglobin Variants: Specific sample sizes for these tests are not provided, but imply testing of prepared specimens with varying concentrations.

Data Provenance:

• Country of Origin: Not explicitly stated, but "four (4) clinical sites" and "physician's offices" for point-of-care clinical performance studies indicate real-world clinical settings. The FDA submission suggests a US-centric regulatory and approval process.
• Retrospective or Prospective: The "Method Comparison" and "Precision" studies involved collecting and measuring samples, suggesting a prospective design for these clinical performance studies. The "Bench testing" for linearity and interference would be laboratory-based and controlled.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention "experts" in the context of establishing ground truth in the way one would for image-based AI studies (e.g., radiologists reviewing images).

For this device, the "ground truth" is established by a reference method or a "NGSP Certified central laboratory reference method" for HbA1c measurements, which are analytical instruments and laboratory processes, not human experts making subjective assessments.

• Method Comparison: Compared to an "NGSP Certified central laboratory reference method." NGSP (National Glycohemoglobin Standardization Program) certification implies a high standard of analytical accuracy and traceability to a primary reference method, essentially serving as a highly precise chemical/metrological "ground truth."

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative diagnostic test where the "ground truth" is established by a reference laboratory method, not by human interpretation or consensus that would require adjudication.

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 typically performed for imaging diagnostics or other subjective interpretation tasks where human readers' performance with and without AI assistance is evaluated. This device is a quantitative assay, with performance evaluated against a reference laboratory method and through precision studies, not human reader performance.

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

Yes, the performance data presented (Linearity, Interference, Total Hemoglobin Interference, Method Comparison against a reference lab, Precision, Hemoglobin Derivative/Fractions, and Hemoglobin Variants) represents the standalone performance of the Nova Allegro HbA1c Assay and Analyzer. The results are generated directly by the device and compared to established analytical standards or reference methods. There is no human-in-the-loop component in the device's measurement process that is being evaluated in these tests.

7. The Type of Ground Truth Used

• Reference Method/NGSP Certified Central Laboratory Reference Method: For Linearity and Method Comparison studies, the device's measurements were compared against a "reference method" and an "NGSP Certified central laboratory reference method." This is an analytical ground truth based on established, highly accurate laboratory techniques.
• Prepared Samples with Known Concentrations: For Interference testing, Hemoglobin Derivative and Fractions, and Hemoglobin Variants, prepared hemolysate specimens with known concentrations of interfering substances or variants were used. This constitutes a controlled, analytical ground truth where the expected outcome is known based on the sample preparation.
• Control Solutions: For 20-Day Imprecision testing, "Nova Allegro HbA1c Control Solutions" were used, which are materials with known, stable HbA1c values, serving as an analytical ground truth for precision assessment.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/algorithm. This device is a diagnostic assay and analyzer, not an AI algorithm that undergoes machine learning training. The "development" of such a device involves chemical and engineering optimization, and analytical validation. Therefore, the concept of a "training set" as understood in machine learning is not applicable here.

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

As noted above, the concept of a training set and its ground truth is not applicable to this type of medical device (a quantitative diagnostic assay). The device's operational range and internal calibration would be established through a process of characterization and calibration using traceable standards and reference materials, which is standard for analytical instruments.

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The Hipro® Glycosylated Hemoglobin (HbA1c) Test System comprised of the Hipro Glycosylated hemoglobin (HbA1c) test kit and the HP-AFS/1 automatic immunoassay analyzer is used as an aid in diagnosis of diabetes mellitus, 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. It is an in vitro diagnostics reagent system intended for quantitative determination of % hemoglobin A1c (DCCT/NGSP) in venous whole blood.

The Hipro® Glycosylated hemoglobin (HbA1c) test system is intended for quantitative determination of % hemoglobin A 1c (DCCT/NGSP) in venous whole blood. It is composed of Glycosylated hemoglobin (HbA1c) test kit and automatic immunoassay analyzer. Glycosylated hemoglobin (HbA1c) test kit consists of two reagents R1 and R2, which are liquid and ready to use. Reagent R1 contains glycine buffer and latex, and reagent R2 contains glycine buffer and two types of antibodies, Goat anti-mouse IgG, mouse anti-human HbAlc monoclonal antibody.

HP-AFS/1 Automatic Immunoassay Analyzer is made up of light absorption test module, scattered light test module, fluorescence test module, press components, data transmission interface and printer. And the absorption test module is made up of absorption light path unit, and lightabsorption sensor part. The scattered light test module is made up of scattered light path unit and scattered light sensor part.

Here's a breakdown of the acceptance criteria and the study details for the Hipro® Glycosylated Hemoglobin (HbA1c) Test System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for most tests. Instead, it describes performing studies and concluding whether "All acceptance criteria were met" or providing summary statistics. For the purpose of this table, I will infer relevant criteria based on common industry standards for diagnostic devices and the structure of the reported results. For Method Comparison, Total Error, and Linearity, the reported results are directly in line with typical performance metrics. For Interference and Hemoglobin Variants, "met acceptance criteria" and specific thresholds are mentioned.

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

• Precision: Four EDTA K2 whole blood samples with targeted HbA1c concentrations (5.2%, 6.4%, 8.0% and 12.3%) and two controls (6% and 11%). Each sample was analyzed in duplicate per run, two runs per day for 20 days on three analyzers (total of 240 measurements per sample/control).
• Method Comparison: One hundred and twenty (120) samples.
• Linearity: One dilution series consisting of 9 levels. Each level measured in triplicate.
• Endogenous Interference: Pooled whole blood samples with two HbA1c levels, spiked with 5 interferents (10 spiked samples), and one unspiked pool. A 10-level dilution series was created for each. Tested ten-fold.
• Drug Interference: Native patient samples at 2 different HbA1c levels, spiked with 16 drugs at two defined concentrations. Measured ten-fold.
• Hemoglobin Variants: 20 samples for each variant (HbC, HbD, HbE, HbF, HbS, HbA2) for a total of 120 samples. Each sample was tested twice.

Data Provenance:

• Method Comparison: The 120 samples were obtained from the NGSP reference laboratory.
• General: The document does not explicitly state the country of origin or whether samples were retrospective or prospective, but the reliance on the NGSP reference laboratory suggests a standardized, potentially retrospective, approach for the method comparison component. The use of "native patient samples" for drug interference suggests clinical sources.

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

The establishment of ground truth is primarily through a traceable reference method and a standardization program.

• Method Comparison: The test system was compared against the Bio-Rad Hemoglobin Testing System which was certified by the National Glycohemoglobin Standardization Program (NGSP). The NGSP is a program that standardizes HbA1c results to align with the results of the Diabetes Control and Complications Trial (DCCT). This implies that the 'ground truth' is established by the NGSP's reference methods and processes, rather than individual experts adjudicating each case. The document specifies that the NGSP reference laboratory measured the "X axis" samples.

The document does not specify a number of "experts" in the traditional sense of clinicians or radiologists adjudicating individual cases.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of imaging or clinical cases. The "ground truth" is established by a reference laboratory measurement (NGSP Bio-Rad Hemoglobin Testing System) for chemical analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test system for quantitative determination of HbA1c, not a diagnostic imaging or AI-assisted interpretation device that involves human readers.

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

Yes, the studies described are standalone performance evaluations of the Hipro® Glycosylated Hemoglobin (HbA1c) Test System (the automatic immunoassay analyzer and test kit) without human intervention in the measurement process. The system quantifies HbA1c levels directly.

7. The Type of Ground Truth Used

• Reference Method: For method comparison, the ground truth was established by the NGSP (National Glycohemoglobin Standardization Program) Bio-Rad Hemoglobin Testing System. The device is certified with NGSP.
• Reference Materials: For precision, linearity, interference, and hemoglobin variant studies, the ground truth for HbA1c concentrations was established using characterized samples (e.g., targeted HbA1c concentrations, spiked samples, varying hemoglobin variant concentrations) which would derive their values from established reference methods or known preparations.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" in the context of an AI/ML algorithm that is trained. This device is a chemical assay system, not an AI/ML-based diagnostic. The described studies are all for performance evaluation (test set) of the final device.

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

Not applicable, as there is no specific "training set" for an AI/ML algorithm mentioned for this device.

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Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (1c, HbA1c) in venous and capillary human whole blood. The measurement of % HbA1c is recommended as a marker of longterm metabolic control in persons with diabetes mellitus.

Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ test cartridges is for in vitro diagnostic use only.

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

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

The Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus.

The Afinion™ HbA1c assay is designed to be used with the Afinion™ AS100 Analyzer and the Afinion™ 2 analyzer which are compact multi-assay analyzers for point-of-care testing. Quality control using the Afinion™ HbA1c Control is recommended to confirm that the system is working properly and provides reliable results.

The provided text is a 510(k) premarket notification for a medical device, specifically an in-vitro diagnostic test. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical performance study for an AI/ML-based medical device.

The document discusses analytical performance characteristics but does not present clinical performance data with a test set, ground truth established by experts, or MRMC studies. The core of this submission is about demonstrating equivalence to existing, cleared devices rather than providing novel clinical efficacy data for a new type of device or an AI algorithm.

Therefore, I cannot provide all the requested information for an AI/ML device study. I can extract the analytical performance characteristics that serve as "acceptance criteria" for this IVD and the reported device performance within the scope of this regulatory submission.

Here's an attempt to answer the questions based on the provided document, noting the limitations of the document's content for AI/ML specific criteria:

Device: Afinion™ HbA1c, Afinion™ 2, Alere Afinion™ AS100 Analyzer

The device is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used as a marker for long-term metabolic control in persons with diabetes mellitus. This is a chemical assay, not an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to analytical performance specifications, not clinical performance for an AI/ML algorithm. The document presents a comparison of the "Candidate Device" (Modified Afinion™ HbA1c) with predicate devices, highlighting improvements or more detailed specifications for analytical specificity and interference.

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The Aina HbA1c Monitoring System 2 consists of the Aina 2 Automated HbA1c Device, Aina HbA1c Test Kits, mobile device, and the Aina Mobile Application. It is intended to be used for quantitative measurement of % HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood. It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not in the diagnosis of or screening for diabetes or for use on neonates.

The system consists of the Aina 2 Automated HbA1c Device for sample processing that connects to a smartphone via Bluetooth, the Aina Device for optical test strip readout, Aina HbA1c Test Kits which contain all the reagents necessary for running each HbA1c test, and the Aina Mobile Application. The Aina Device is a reflectance-based colorimetric sensor device that connects to the mobile device through the audio jack. The smartphone runs the Aina Mobile Application, which is software that allows for user interaction and illustrates the step-by-step testing process on its touchscreen. The Aina Mobile Application software is responsible for analyzing the optical signals measured by and transferred to it by the Aina Device, including applying analysis algorithms to compute the HbA1c reading. In addition, the Aina Mobile Application controls the functioning of the Aina 2 Automated HbA1c Device by sending it commands via Bluetooth. Streck A1c-Cellular control solutions can be used for regular quality control checking of the system.

Here's an analysis of the acceptance criteria and study details for the Aina HbA1c Monitoring System 2, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. However, it does present performance data from various studies. Based on the data provided, the implied acceptance criteria would be that the device demonstrates comparable performance to established methods and exhibits suitable analytical performance characteristics.

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

• Test Set (Clinical Accuracy): n=132 (for regression analysis) fresh prospective venous whole blood samples.
• Data Provenance: Samples collected from study participants at three (3) clinical sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in Boston, MA, suggesting the clinical sites were likely in the United States. The study design was prospective (fresh samples).

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

• The ground truth for the clinical accuracy study was established using the Tosoh G8 reference method. This is an automated laboratory analyzer, considered a high-performance liquid chromatography (HPLC) system, which is a widely accepted reference method for HbA1c measurement.
• No human "experts" were used to establish the ground truth in terms of reading images or diagnosing. The ground truth was based on the measurement from a validated reference instrument.

4. Adjudication Method for the Test Set:

• This is not applicable as the ground truth was established by an automated reference method (Tosoh G8) rather than human experts requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) measurement system, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers improving with AI.

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

• Yes, the performance studies described are for the "Aina HbA1c Monitoring System 2" acting as a standalone device. While healthcare professionals operate the device, the reported performance metrics (repeatability, linearity, clinical accuracy) are of the device as a measurement system. The "Aina Mobile Application" applies analysis algorithms to compute the HbA1c reading, which is the core of its "standalone" algorithmic performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• The ground truth for the clinical accuracy study was established using a validated reference laboratory method: the Tosoh G8 for HbA1c measurement. This is considered a highly accurate and standardized method.

8. The Sample Size for the Training Set:

• The document does not provide information on the sample size used for the training set. This is a common omission in 510(k) summaries for IVD devices, as the focus is typically on the analytical and clinical validation of the final product, rather than the deep learning model's training specifics. It does mention the "Aina Mobile Application software is responsible for analyzing the optical signals measured by and transferred to it by the Aina Device, including applying analysis algorithms to compute the HbA1c reading," implying there are algorithms that would have been developed and potentially "trained," but no training data specifics are given.

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

• Since no information about a dedicated training set is provided, the method for establishing its ground truth is also not detailed. Assuming standard IVD development, any internal optimization or calibration (which might be analogous to "training") would typically use samples characterized by a reference method similar to, or the same as, the one used for the clinical validation (e.g., Tosoh G8 or other established HbA1c reference methods).

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The HbA 1c (Hemoglobin A 1c) Advanced assay on the Beckman Coulter DxC700 AU Clinical Chemistry Analyzer, is intended for the quantitative determination of mmol/mol HbA1c (DCCT/NGSP) concentration in human venous whole blood. The determination of HbA1c is used as an aid in the diagnosis of diabetes mellitus, for the monitoring of long-term glucose control in individuals with diabetes mellitus and identifying patients who may be at risk for developing diabetes mellitus. For in vitro diagnostic use only.

The HbA1c Advanced reagent kit is in a liquid format and is ready to use. It contains four reagents HbA1c R1 and HbA1c R2, Total Hemoglobin R1 and Hemolyzing reagent R1. The HbA1c calibrator is supplied with the reagent, in a liquid, ready to use format and contains 5 x 2mL calibrator levels. The sample hemolysis is automated on the DxC700 AU Clinical Chemistry analyzer. Sample handling is performed as follows: 200 uL of hemolyzing reagent is aspirated from the Hemolyzing Reagent R1and dispensed into a cuvette. Tetradecyltrimethylammonium bromide (TTAB) in the hemolyzing reagent eliminates interference from leukocytes. 2 µL of whole blood sample is then aspirated from the patient sample and added to the hemolyzing reagent in the cuvette. This hemolyzed whole blood is then added to the THb assay cuvette and HbA1c assay cuvette as per the assay parameters. The concentrations of both HbA1c and Total Hemoglobin are determined. The HbA1c/Total Hemoglobin ratio is expressed either as mmol/mol (IFCC) or %HbA1c (DCCT/NGSP). Total Hemoglobin Reagent is used to measure total hemoglobin concentration by a colorimetric method. Change in absorbance is measured at 570/660 nm. HbA1c reagent is used to measure hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with HbA1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. Change in absorbance is measured at 340/700 nm.

Here's an analysis of the acceptance criteria and study details for the HbA1c Advanced device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Precision (EP05-A3): Four levels of HbA1c K2 EDTA human venous whole blood patient samples (approx. 5.0%, 6.5%, 8.0%, 12%, and 14%) and two whole blood controls. Samples were analyzed in duplicate, twice daily, over 20 working days on 3 different instrument lots. (n=2 for each sample/control, 2x daily, 20 days: 80 measurements per sample/control per instrument, total for all samples/controls/instruments: 8073 = 1680 individual measurements for precision)
   • Linearity (EP06-A): High and low pools of human whole blood were used to create a linearity series to span the analytical range. The exact number of samples in the linearity series is implied to be at least 9 (N: ≥ 9 for regression parameters).
   • Method Comparison (EP09-A3): 138 venous human frozen whole blood specimens (K2 EDTA anticoagulant type). These were patient samples. The provenance is not explicitly stated as country of origin, but they are referred to as "venous human frozen whole blood specimens." The study design is prospective in the sense that the samples were collected and then tested for the study; it is not explicitly called out as retrospective/prospective.
   • Analytical Specificity (Interference - EP07): Two % HbA1c concentrations (approx. 6.5% and 8.0% HbA1c) using low and high pools prepared from human whole blood. Interfering substances were tested at a minimum of 5 levels each, with 10 replicates per level. The interference assessment was done on human venous whole blood K2 EDTA samples.
   • Hemoglobin Variants: A minimum of 20 samples were tested for each variant (HbC, HbD, HbE, HbF, HbS, HbA2), totaling at least 120 samples. These are patient samples with identified hemoglobin variants.

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

   • For the Method Comparison study, the ground truth was established by an "NGSP Secondary Reference Laboratory (SRL) using a test system (method X - HA8180V HPLC)." The specific number and qualifications of experts at the SRL are not detailed in this document.
   • For Hemoglobin Variants, the reference methods used to establish the ground truth were "Trinity Biotech Hb9210 and Ultra2, Menarini HA8181V and TOSOH G8," which are demonstrated to be free from hemoglobin interference. Again, the number and qualifications of the operators of these reference methods are not specified.

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

   • The document does not describe an adjudication method involving multiple human readers for establishing ground truth. The ground truth for method comparison and hemoglobin variant studies relies on reference methods/laboratories.

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:

   • No MRMC comparative effectiveness study involving human readers or AI assistance was conducted or described, as this device is an in-vitro diagnostic (IVD) test system (HbA1c assay) and not an imaging AI device that would typically involve human reader interpretation.

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

   • Yes, the performance characteristics described are for the "HbA1c Advanced reagent on the DxC 700 AU Clinical Chemistry Analyzer" as a standalone device (algorithm only performance, in a laboratory setting). The entire submission details the analytical performance of the device itself.

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

   • Precision: Internal validation against the device's own specifications.
   • Linearity: Internal validation for demonstrating accurate measurement across specific concentration ranges.
   • Method Comparison: Comparison to an NGSP Secondary Reference Laboratory (SRL) standardized method (HA8180V HPLC).
   • Analytical Specificity (Interference): Comparison to baseline measurements of samples without interferents, assessed against a 7% recovery criteria.
   • Hemoglobin Variants: Comparison to reference methods demonstrated to be free from hemoglobin interference (Trinity Biotech Hb9210 and Ultra2, Menarini HA8181V and TOSOH G8).

7. The sample size for the training set:

   • This document describes the analytical validation of a biochemical assay on an automated analyzer. There is no "training set" in the context of machine learning, as the device is a reagent and instrument system, not an AI/ML algorithm that is trained on data. The device's performance is rigorously tested as described above.

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

   • Not applicable, as this is not an AI/ML device with a training set. The assay's analytical parameters are established through chemical and immunochemical principles and optimized during development.

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Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% homoglobin Alc, HbAlc) in human venous and capillary whole blood.

This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

The Afinion™ 2 System consisting of the Afinion™ 2 Analyser and the Afinion™ Test Cartridges is for in vitro diagnostic use only. The Afinion™ 2 Analyzer is a compact multi-of-care testing and is designed to analyze the Afinion™ Test Cartridges.

The Afinion™ HbA1c Dx test system is a CLIA moderate complexity test for diagnosing diabetes and identifying patients who may be at risk for developing diabetes, as a marker of long-term metabolic control in persons with diabetes mellitus.

The Afinion 2 is a multi-assay analyzer for point-of-care testing, designed for use with Afinion assay test cartridges and Afinion controls. It has the same functionality as the Afinion AS100 analyzer performing identical assay processing.

The provided text describes the 510(k) premarket notification for the Afinion™ HbA1c Dx on Afinion™ 2 device. It focuses on demonstrating substantial equivalence to a predicate device (Afinion™ HbA1c Dx on Alere Afinion™ AS100 Analyzer) rather than explicitly outlining a standalone clinical study for new acceptance criteria.

However, the document states: "Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met." It implies that acceptance criteria were established and subsequently met through these studies. The core of the submission is to show that the modified Afinion 2 analyzer performs equivalently to the previous AS100 analyzer when running the same Afinion HbA1c Dx test.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy, precision targets) and their corresponding reported device performance values in a table format. Instead, it broadly states that "all acceptance criteria were met" and that the analytical performance was not adversely affected.

However, by comparing the candidate device (Afinion™ HbA1c Dx with Afinion™ 2 analyzer) to the predicate device, we can infer that the acceptance criterion for the new analyzer is to maintain the same performance characteristics as the predicate. The "reported device performance" is the demonstration that its performance is equivalent.

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

The document mentions "in-house analytical performance verification studies" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to these as part of "design control activities" to address risk analysis.

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

This information is not provided in the document. The nature of the device (an HbA1c test system) suggests that "ground truth" would likely be based on established reference methods or certified values, rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given the type of diagnostic test (quantitative determination of glycated hemoglobin), clinical adjudication by experts is unlikely to be the primary method for determining ground truth.

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

A MRMC study is typically for evaluating human reader performance, often in image-based diagnostics. This device is an automated in vitro diagnostic test system. Therefore, an MRMC comparative effectiveness study involving human readers is not applicable and was not performed.

6. Standalone (Algorithm Only) Performance:

The entire submission focuses on the performance of the "Afinion™ HbA1c Dx on Afinion™ 2" as a complete system, which is an automated diagnostic test. Therefore, the "standalone" performance is the algorithm's performance integrated into the device, using the specified test cartridges. There is no human-in-the-loop component for the measurement itself. The study details, though not fully disclosed, would pertain to the device operating in this standalone manner.

7. Type of Ground Truth Used:

The document states that the Afinion HbA1c Dx is "traceable to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Reference Method for Measurement of HbA1c" and "certified by NGSP (National Glycohemoglobin Standardization Program)." This indicates that the ground truth for performance evaluation (e.g., accuracy, bias) is established by reference methods and standardization programs rather than expert consensus, pathology, or direct outcomes data.

8. Sample Size for the Training Set:

The document does not provide details on a "training set" or its sample size. This type of device is likely developed and validated using a more traditional analytical validation approach based on measurement science, rather than a machine learning paradigm that typically involves distinct training and test sets. It implies a process of design, calibration, and verification/validation.

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

As there is no mention of a traditional "training set" in the context of machine learning, this information is not applicable and a method for establishing its ground truth is not provided. The development and calibration of the test would rely on rigorous analytical methods and established reference materials, as indicated by its traceability to IFCC and NGSP certification.

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The SEKURE HbA1c assay is used to measure the percent concentration of hemoglobin A1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate on the SK500 Clinical Chemistry System. Measurement of HbA 1c is used as an aid in the diagnosis of diabetes mellitus, as an aid in the identification of patients at risk for development of diabetes mellitus, and for the monitoring of long-term blood glucose with diabetes mellitus. For In Vitro Diagnostic Use Only.

The SEKURE HbA1c assay is an enzymatic assay for the measurement of the percent hemoglobin A1c concentration. The assay consists of a pre-treatment hemolyzing buffer solution and two working reagents. Testing is performed on the SK500 K103531in conjunction with calibrators and controls which will be provided separately.

The SEKURE HbA1c Assay is an in vitro diagnostic device used to measure the percentage concentration of hemoglobin A1c (HbA1c) in human venous whole blood and hemolysate. It's intended to aid in the diagnosis and monitoring of diabetes mellitus. The device's performance was evaluated through various non-clinical studies to demonstrate its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

Precision (NGSP Units, Whole Blood)

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Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood.

This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

The Afinion™ HbA1c Dx is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c in human whole blood. The Afinion™ HbA1c Dx is a modification of the existing device, Alere Afinion™ HbA1c for use with the Alere Afinion™ AS100 Analyzer, with the addition of a diagnostic intended use.

The test begins with a blood sample collected with the integrated sampling device before the test cartridge is placed in the cartridge chamber of the Alere Afinion™ AS100 Analyzer. The sample is then automatically diluted and mixed with a solution that releases hemoglobin from the erythrocytes. After the hemoglobin is precipitated, the sample mixture is transferred to a blue boronic acid conjugate which binds to the cis-diols of glycated hemoglobin. This reaction mixture is soaked through a filter membrane and all precipitated hemoglobin, conjugate-bound and unbound (i.e. glycated and non-glycated hemoglobin) remains on the membrane. Excess conjugate is removed with a washing reagent. The analyzer measures the reflectance of the precipitate on the membrane as blue (glycated hemoglobin) and red (total hemoglobin) color intensities. The analyzer calculates a ratio proportional to the percentage of HbA1c in the sample and displays as the % HbA1c (NGSP).

The medical device is the Afinion™ HbA1c Dx, a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c in human whole blood. It is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood. Its intended use is as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is also used as a marker of long-term metabolic control in persons with diabetes mellitus.

1. Table of Acceptance Criteria and Reported Device Performance

All reported TE values are ≤ 6.0%. |
| Precision/Reproducibility | Not explicitly stated as a single numerical acceptance criteria in terms of SD or CV, but assessed through detailed studies. | Internal (Venous Whole Blood): Total %CV ranged from 1.32% to 1.74% across HbA1c levels and analyzers.
External (Venous Whole Blood): Total %CV ranged from 1.22% to 1.78% across HbA1c levels.
Fingerstick Samples (Combined Studies): Total %CV ranged from 1.30% to 2.03% across HbA1c levels. |
| Linearity/Reportable Range | No specific numerical acceptance criterion stated, but implicitly expected to cover the medical decision range. | Reportable range: 4.00-15.00 % HbA1c (DCCT/NGSP). Previously established in K050574. |
| Endogenous Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed for tested substances (Bilirubin, Glucose, Intralipid, Rheumatoid factor, Total protein) at specified concentrations. |
| Hemolysis Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed up to 24% hemolysis. Information codes related to hemolysis may occur above 14% hemolysis. |
| Drug Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed for 20 tested drugs at specified concentrations. |
| Cross-reactivity with Hemoglobin Derivatives | Significant interference defined as exceeding a 7% change in %HbA1c value from control. | No significant interference observed for Acetylated hemoglobin, Carbamylated hemoglobin, Labile HbA1c, and Glycated albumin at specified concentrations. |
| Hemoglobin Variants Interference | Significant interference defined as exceeding a 7% change in %HbA1c value from reference method. | No significant interference for HbA2, HbS, HbC, HbE, HbD. Significant negative interference with HbF (highest concentration with no significant interference at 10.4% HbF). Device includes a prominent boxed warning for HbF. |

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

• Accuracy/Method Comparison Study (Test Set):
  • Sample Size: 120 subjects.
  • Data Provenance: Samples from each study subject were tested with both fingerstick samples and fresh venous EDTA samples. Divided across three study sites. Retrospective or prospective is not explicitly stated, but the collection of fresh venous and fingerstick samples suggests it was prospective. The country of origin of the data is not specified.
• Precision (Internal, Venous Whole Blood): 4 levels of HbA1c patient samples. Each level tested with 2 replicates, twice a day for 20 days with 3 lots on 3 analyzers. (240 measurements per analyzer, 720 combined).
• Precision (External, Venous Whole Blood): 4 levels of HbA1c patient samples. 4 replicates analyzed twice a day for 10 days with 3 lots at each of 3 sites, using 3 analyzers.
• Precision (Fingerstick Samples):
  • Study A (Accuracy study - within-run): 172 subjects (fingerstick samples in duplicate).
  • Study C (Between-instrument and between-operator): 15-16 subjects per HbA1c level (total of 4 levels) across 3 sites. Each subject gave 6 fingerstick samples. Total of 90-96 fingerstick measurements per level.
• Between-Instrument Precision: 4 venous whole blood samples measured in 6 replicates on each of 14 analyzers with 1 test cartridge lot (total of 84 replicates per sample).
• Lot-to-Lot Variation: 18 EDTA venous whole blood samples spanning the reportable range. Each sample analyzed in 1 replicate with each of 3 test cartridge lots on the same analyzer.
• Endogenous/Hemolysis/Drug Interference, Hemoglobin Derivatives Cross-reactivity: Whole blood sample pools. Specific number of samples not given, but tested with 10 replicates for each condition/substance.
• Hemoglobin Variants Interference: 234 fresh EDTA whole blood samples containing 6 common hemoglobin variants. Also, 100 samples for HbA0, HbA1a, HbA1b components.

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

• For the Method Comparison study, the ground truth was established by an NGSP secondary reference laboratory method (Tosoh Glycohemoglobin test on the G8 HPLC analyzer). This method itself serves as the "expert" or gold standard. The document does not specify the number or qualifications of human experts involved in operating or verifying this reference method.

4. Adjudication Method for the Test Set

• The document implies that the reference method (Tosoh G8 HPLC) was considered the definitive ground truth for the method comparison study. There is no mention of a human adjudication method (like 2+1 or 3+1 consensus) for the test set results against the reference method. The comparison was statistical, using Deming and Passing-Bablok regressions.

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 device is an automated in vitro diagnostic test (HbA1c assay). It does not appear to involve "human readers" in the sense of image interpretation or other judgmental tasks where AI assistance might improve their performance. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device.

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

• Yes, the performance studies described are for the "algorithm only" (device only) performance. The Afinion™ HbA1c Dx is a fully automated system for determining HbA1c. The performance metrics (precision, accuracy, interference, etc.) reflect the standalone operation of the device.

7. The Type of Ground Truth Used

• The ground truth used for the method comparison and hemoglobin variant interference studies was a reference method, specifically an NGSP secondary reference laboratory method (Tosoh Glycohemoglobin test on the G8 HPLC analyzer). For interference studies, the ground truth was derived from non-spiked control samples or reference samples without the interfering substance.

8. The Sample Size for the Training Set

• The document describes performance characteristics for the Afinion™ HbA1c Dx. It does not provide information on a separate "training set" for an algorithm, as this typically applies to machine learning models. Instead, the device is a chemical assay with established analytical principles. Therefore, a distinct "training set" size in the context of an AI/ML algorithm is not applicable as presented in this document. The "training" or development would refer more to the optimization and validation of the analytical method itself.

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

• As a chemical assay rather than an AI/ML algorithm, the concept of a "training set" with established ground truth is not applicable in the same way. The device's analytical method (boronate affinity assay) is based on scientific principles and validated through extensive performance testing as detailed in the document, against established reference methods.

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ACE Hemoglobin A lc (HbA lc) Reagent is intended for the quantitative determination of percent hemoglobin A lc in venous whole blood collected in K2-EDTA tubes using the ACE Axcel® Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.

The ACE Hemoglobin A1c (HbA1c) Reagent assay requires a pretreatment step of denaturation of the whole blood samples, which is performed off-line. The red blood cells in the sample are lysed by the Hemoglobin Denaturant and the hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex agglutination inhibition assay is used. In the absence of HbA1c in the sample, the synthetic polymer containing the immunoreactive portion of HbA 1c Agglutinator Reagent will agglutinate with the antibody-coated microparticles in the HbA1c Antibody Reagent. The presence of HbA1c in the blood sample competes for the antibody binding sites and inhibits agglutination. The increase in absorbance, monochromatically at 692 mm, is inversely proportional to the HbA1c present in the sample. For the determination of total hemoglobin, all hemoglobin derivatives in the sample are converted to alkaline hematin. The reaction produces a green colored solution. which is measured bichromatically at 573 nm/692 nm. The intensity of color produced is directly proportional to the total hemoglobin concentration in the sample. The concentrations of both HbA 1 c and total hemoglobin are measured, the ratio is calculated, and the result reported as percent HbA1c.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE Hemoglobin A1c (HbA1c) Reagent device are implicitly established by demonstrating comparable performance to the predicate device, the DCA 2000+ System for Hemoglobin A1c (K951361), across a range of analytical performance characteristics. While explicit numerical acceptance criteria are not always stated, the study aims to show that the new device's performance aligns with acceptable standards for HbA1c measurement in clinical diagnostics.

Here's a table summarizing the reported device performance:

Study Details:

2. Sample Size and Data Provenance for Test Set:

• Linearity: 11 samples were used for both HbA1c and Total Hemoglobin linearity studies, run in 4 replicates each, for both the ACE Alera and ACE Axcel systems.
• Precision (In-house): 4 samples (A, B, C, D) were tested, but the number of runs/replicates to calculate SD and %CV is not explicitly stated in the table. Typically, precision studies involve multiple replicates over several days.
• Precision (Physician Office Labs - POLs): 4 samples were tested across 3 POLs for each instrument (ACE Alera and ACE Axcel). Similar to in-house, the specific number of runs/replicates per POL for SD and %CV calculation is not detailed.
• Comparative Analysis (In-house): 101 samples for ACE Alera and 102 samples for ACE Axcel were compared against the predicate device (DCA 2000+).
• Comparative Analysis (POLs): 50 samples per POL for a total of 150 samples for ACE Alera, and 52 samples for one POL and 50 samples for the other two POLs (total 152 samples) for ACE Axcel were compared against the predicate device (DCA 2000+).
• Analytical Specificity/Cross-Reactivity: The number of samples for these studies is not explicitly stated, but typically involves spiking known concentrations of interferents into samples and measuring the effect.
• Data Provenance: The studies were conducted in-house by Alfa Wassermann Diagnostic Technologies, LLC, and in external Physician Office Laboratories (POLs). Given the nature of performance validation for a diagnostic device, these studies are prospective, as samples are analyzed using the new device and compared against a reference method or predicate. The "country of origin of the data" is implicitly the United States, where the manufacturer and the POLs are located.

3. Number of Experts and their Qualifications for Ground Truth:

The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for the test set. For an in vitro diagnostic device measuring a quantitative analyte like HbA1c, the ground truth is typically established by:

• Reference Methods: Highly accurate and precise analytical methods, often traceable to international standards (e.g., NGSP, IFCC), which are considered the "gold standard" for measuring the analyte.
• Predicate Devices: Comparison to a legally marketed device that has already established its safety and effectiveness.

In this case, the ground truth for the comparative studies was derived from the predicate device (DCA 2000+ System for Hemoglobin A1c), which is itself NGSP Certified and traceable to IFCC reference materials.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or complex diagnostic assessments by human readers, where discrepancies between readers need to be resolved. For a quantitative in vitro diagnostic device, the ground truth is established analytically through reference methods or predicate comparison, not through expert consensus requiring adjudication.

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

Not applicable. MRMC studies are generally performed for image-based diagnostic aids or other devices where human interpretation plays a significant role in the diagnostic outcome. This document describes the analytical performance validation of an in vitro diagnostic reagent, which is a quantitative measurement, not an interpretative task for human readers in the context of an MRMC study. Therefore, no effect size of human readers improving with AI vs. without AI assistance is relevant or reported.

6. Standalone (Algorithm Only) Performance Study:

Yes, this entire submission focuses on the standalone performance of the ACE Hemoglobin A1c (HbA1c) Reagent when used with the ACE Alera® and ACE Axcel® Clinical Chemistry Systems. The studies presented (linearity, precision, comparative analysis, specificity, cross-reactivity) all evaluate the direct analytical performance of the device itself, without human intervention for interpretation beyond standard laboratory procedures for operating the instrument and processing samples.

7. Type of Ground Truth Used:

The ground truth used for the comparative analysis studies was the predicate device, the DCA 2000+ System for Hemoglobin A1c. The document explicitly states that the DCA Hemoglobin A1c test method is National Glycohemoglobin Standardization Program (NGSP) Certified and is traceable to International Federation of Clinical Chemistry (IFCC) reference materials and test methods. This indicates that the predicate device serves as a highly standardized and accepted reference for HbA1c measurement.

8. Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is a diagnostic reagent kit for a clinical chemistry system, not a software algorithm that requires a separate training phase with a distinct dataset. The performance data presented are for the validation of the finalized device.

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

As there is no "training set" in the context of this device being a reagent for a clinical chemistry system, this question is not applicable. The device's design and formulation would have been developed through internal R&D, likely using internal validation and optimization experiments, but these are not typically referred to as a "training set" with established ground truth in the same way as for AI/ML models. The ground truth for the validation of the device's performance (as described above) was established by comparison to the NGSP/IFCC-traceable predicate device.

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Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afmion™ test cartridges is for in vitro diagnostic use only.

Alere Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus.

The Alere Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine the Afinion™ 2 analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

The Afinion™ 2 analyzer is a multi-assay analyzer for point-of-care testing, designed for use with Alere Afinion™ assays. The Afinion™ 2 analyzer is a modification, a new model, of the previously cleared device Alere Afinion™ AS100 Analyzer.

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and study information related to the Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer:

Due to the nature of the provided document (a 510(k) summary), the level of detail you're requesting, especially concerning specific numerical acceptance criteria, detailed study designs, and ground truth establishment for training sets, is generally not fully disclosed. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design modifications and verification/validation.

However, I will extract all available information and highlight what is not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria alongside reported device performance for analytical studies. Instead, it states that "All requirements for Alere Afinion™ AS100 Analyzer have been re-verified for Afinion™ 2 analyzer through tests both at system level and discipline level (electronics, mechanics and software)." and "Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met."

This implies that the acceptance criteria for the Afinion™ 2 analyzer were established to ensure its performance was equivalent to, or did not degrade from, the predicate Afinion™ AS100 Analyzer. The specific performance metrics (e.g., accuracy, precision) for HbA1c and ACR assays would have been assessed, but their numerical targets are not detailed in this summary.

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

The document does not explicitly state the sample sizes for the test sets used in the verification and validation studies.

Regarding data provenance: studies were "in-house analytical performance verification studies." This suggests the data was collected by the manufacturer. The location of Abbott Rapid Diagnostics for the applicant is listed as Kjelsaasveien 161, PO Box 6863 Rodeloekka, NO-0504 Oslo, Norway, which implies data collection might have occurred there or at other internal Abbott facilities. The document does not specify if the data was retrospective or prospective, though "verification studies" often involve prospective collection or use of specific samples to test performance.

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

This information is not provided. For device performance verification, ground truth typically refers to reference measurements from established, highly accurate methods or external laboratories. The document doesn't detail how this reference standard was obtained or if human experts were involved in establishing it beyond standard laboratory practices.

4. Adjudication Method for the Test Set

This information is not provided. Since the device measures quantitative biomarkers (HbA1c and ACR), "adjudication" in the context of expert consensus for subjective interpretations (like in imaging) is not directly applicable here. Performance is typically compared against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret outputs with and without AI assistance. The Alere Afinion™ 2 analyzer is a quantitative measurement device, not an interpretative AI.

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

Yes, the studies described are inherently standalone performance tests for the device. The device measures HbA1c and ACR values independently. The purpose of these verification and validation studies was to confirm that the modified device (Afinion™ 2 analyzer) performs comparably to the predicate device with respect to its analytical capabilities.

7. The Type of Ground Truth Used

While not explicitly stated, for quantitative assays like HbA1c and ACR, the ground truth would typically be established by:

• Reference laboratory methods: Highly accurate and precise laboratory-based methods (e.g., HPLC for HbA1c, or established clinical chemistry methods for albumin and creatinine) often traceable to international standards.
• Certified reference materials: Use of materials with known, certified concentrations of HbA1c, albumin, and creatinine.
• Comparative testing: Measuring samples on a recognized, cleared reference device (in this case, likely the predicate Afinion™ AS100 Analyzer itself, or another gold standard).

The document mentions "analytical performance verification studies," which would rely on such established reference standards.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its size. This device is a quantitative diagnostic instrument, not an AI/ML algorithm that undergoes a distinct training phase. Its design modifications were verified through standard engineering and analytical performance testing, not machine learning training.

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 in this context.

Summary of Available Information from the Provided Text:

• Acceptance Criteria & Performance: "All requirements for Alere Afinion™ AS100 Analyzer have been re-verified for Afinion™ 2 analyzer through tests both at system level and discipline level (electronics, mechanics and software). The risk analysis identified the appropriate in-house analytical performance verification studies to demonstrate that the analytical performance and risk of erroneous results for Alere Afinion™ HbA1c and Alere Afinion™ ACR are not adversely affected by using the modified device. Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met." Specific numerical criteria are not provided.
• Sample Size (Test Set): Not specified.
• Data Provenance (Test Set): "in-house analytical performance verification studies." Implies internal data, potentially from Norway where the applicant is located. Retrospective/Prospective not specified.
• Experts (Ground Truth): Not specified.
• Adjudication Method: Not applicable for a quantitative assay.
• MRMC Study: No.
• Standalone Performance: Yes, the device's analytical performance was assessed.
• Ground Truth Type: Likely reference laboratory methods or certified reference materials, compared to the predicate device.
• Sample Size (Training Set): Not applicable (not an AI/ML device with a distinct training phase).
• Ground Truth (Training Set): Not applicable.

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