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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 Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy.

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 UACR Assay: The Nova Allegro UACR Assay is a completely automated assay for the determination of albumin and creatinine in human urine. The results are used to calculate the UACR (Urine Albumin to Creatinine Ratio). Nova Allegro UACR Test Cartridges are the key element a user interacts with to determine the albumin and creatinine levels in a human urine sample. The main components of the Test Cartridge are the Capillary, the reaction chamber, and the barcode label.

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. 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

The provided text is a 510(k) Summary for the Nova Allegro UACR Assay and Analyzer. It details the device's performance testing results. According to the prompt's request, I will extract relevant information to describe the acceptance criteria and the study proving the device meets these criteria.

It's important to note that this document describes a medical device, specifically an in-vitro diagnostic test, not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML specific quality evaluation criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "effect size of human readers improving with AI," "standalone performance," and details about training sets/ground truth for training, are not applicable in this context. The study performed is a performance validation of a diagnostic assay, comparing its results to a comparative method (CM), not a reader study.

Here's a breakdown of the requested information based on the provided document:

Device: Nova Allegro UACR Assay, Nova Allegro Analyzer
Indications for Use: The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy. 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.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful conclusion of each test and the statement that the data "meets the acceptance criteria" or "demonstrated no significant interference." Specific quantitative acceptance criteria are sometimes stated (e.g.,

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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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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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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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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), Alere Afinion™ Test Cartridges and Alere Afinion™ Controls 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 longterm metabolic control in persons with diabetes mellitus.

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

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 using the Alere Afinion™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

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

The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess or low cholesterol in the blood and lipid and lipoprotein metabolism disorders. Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

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

The Alere Afinion HbA1c test cartridge contains all of the reagents necessary for the determination of % HbA1c. The sample material is collected from a fingerstick or a sample tube with the integrated sampling device before the test cartridge is placed in the cartridge chamber of the Alere Afinion AS100 Analyzer. The blood sample is then automatically diluted and mixed with a solution that releases hemoglobin from the erythrocytes. The hemoglobin precipitates. This 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. Any excess of conjugate is removed with a washing reagent. The analyzer evaluates the precipitate on the membrane. By measuring the reflectance, the blue (glycated hemoglobin) and the red (total hemoglobin) color intensities are evaluated, the ratio between them of which is proportional to the percentage of HbA1c in the sample. The % HbA1c is displayed on the Alere Afinion™ AS100 Analyzer.

The analyzer uses different chemical and mechanical assay methods combined with advanced, computerized processing and measuring technology to perform a variety of diagnostic assays.

A test cartridge with patient sample or control is placed in the cartridge chamber of the analyzer. By manually closing the lid, the test cartridge is transported into the analysis compartment of the analyzer. There is no further user intervention or activity required to perform the assay. Test and lot specific information are obtained from the test cartridge barcode label, which then initiates the processing of the test. The sample and reagents are automatically transferred between the wells of the test cartridge.

A monochrome solid-state camera monitors the entire process. When the assay is completed, lightemitting diodes (LEDs) illuminate the final reaction area, which can be either a colored membrane or a reaction well. The camera detects the reflected or transmitted light, which is converted to a test result and displayed on the touch screen. When the user accepts the result, the lid covering the cartridge chamber opens automatically and the used test cartridge can be removed and discarded. The analyzer is then ready for the next run.

The current sampling device integrated in the test cartridge is made of plastic with a glass capillary tube glued into the sampling device. The new, modified plastic sampling device will be manufactured in one piece of plastic of the same base material (polystyrene) as the plastic part of the current sampling device.

The provided text describes a 510(k) premarket notification for a modification to the Alere Afinion HbA1c and Alere Afinion AS100 Analyzer. The modification specifically concerns the sampling device capillary, changing it from glass to plastic. The document outlines the study (design control activities) performed to demonstrate that the modified device meets acceptance criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "acceptance criteria were set to maintain the efficiency and safety of the assay in the hands of waived users" and that the verification/validation program included studies of "precision, accuracy, robustness and potential interference of plastic additive as well as external waived user studies." However, the specific quantitative acceptance criteria and the detailed reported device performance against these criteria are not provided in the publicly available summary. The document only offers a general statement: "all verification and validation activities were performed and the results demonstrated that the predetermined acceptance criteria were met."

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

The document mentions "in-house studies" and "external waived user studies."

• Sample Size for Test Set: The specific number of samples (e.g., number of patient samples, number of replicates) used in these studies is not explicitly stated in the provided text.
• Data Provenance: The document implies the studies were conducted by Alere Technologies AS. The location of "in-house" studies is likely Norway (where Alere Technologies AS is based). "External waived user studies" suggests data collected from various waived user sites, but no specific countries or locations are mentioned. It is retrospective in the sense that the data proving the device meets acceptance criteria has already been collected and is being used to support the premarket notification.

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

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. Given that the device measures glycated hemoglobin, the ground truth would likely be established using a reference method in a clinical laboratory.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A MRMC comparative effectiveness study, which typically involves human readers and assesses the impact of AI assistance, is not applicable to this device. This device is an in-vitro diagnostic assay and analyzer, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

Yes, a standalone study (algorithm/device only performance) was conducted. The "in-house studies of precision, accuracy, robustness and potential interference of plastic additive" and "external waived user studies" would assess the Alere Afinion AS100 Analyzer's performance with the modified sampling device independently. The entire premise of this 510(k) is to demonstrate the modified device's performance when used alone.

7. Type of Ground Truth Used

The ground truth for the HbA1c measurement would be established by a reference method for glycated hemoglobin in human whole blood, typically performed by a laboratory instrument following established clinical laboratory standards. The document doesn't explicitly state the specific reference method used, but it's implied by the nature of the device (in-vitro diagnostic for quantitative determination of % HbA1c).

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI/machine learning model. This is an IVD device, and the verification and validation studies are typically used to confirm the performance characteristics rather than to train an algorithm.

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

As no training set is mentioned in the context of AI/machine learning for this IVD device, this question is not applicable. The "ground truth" for evaluating the device's accuracy would be established by comparing its results to a recognized reference method.

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The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.

The ASiManager-AT is an integrated digital particle analyzer designed to objectively interpret certain slide agglutination tests manufactured by Arlington Scientific Inc. (ASI). Qualitative and semiquantitative tests are performed by laboratory professionals who use the ASiManager-AT to provide standardized test interpretation using criteria that define reactive and nonreactive agglutination reactions. The ASiManager-AT also delivers an initial predictive titer analysis for the ASI RPR Card Test for Syphilis.
The ASiManager-AT employs a CCD (charge-coupled device) camera that uses light reflectance to create a highly sensitive and high-resolution image of the agglutination immunoassay. This image is then analyzed by the proprietary software algorithm to interpret the agglutination pattern.
The ASiManager-AT further provides tools that enable the creation, storage. retrieval and transmittal of the test results.

The ASiManager-AT device is an integrated digital particle analyzer designed to objectively interpret the ASI RPR Card Test for Syphilis, provide standardized test interpretation, an initial predictive titer analysis, and manage test results.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Qualitative Interpretation:
  • Prospective study: 375 samples.
  • Retrospective study: 3131 samples.
• Predictive Titer Analysis: 1224 reactive samples (a subset of the 1849 reactive samples from qualitative testing).
• Endpoint Titer Determination: 708 reactive samples (a subset of the 1849 reactive samples from qualitative testing).

The document states that the data are "results from three testing sites." It doesn't specify the country of origin. The test sets were a mix of prospective (375 samples) and retrospective (3131 samples) data for qualitative interpretation.

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

The ground truth was established by "trained laboratory professionals" performing "visual interpretation." The document does not specify the number of experts or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). It describes a comparison between the ASiManager-AT's digital results and "visual interpretation" by trained laboratory professionals, implying that the visual interpretation served as the primary reference or ground truth for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 done in the context of human readers with AI assistance versus without AI assistance. The study compares the device's performance against human visual interpretation (the ground truth), not how the device assists human readers to improve their performance. The device is described as providing "standardized test interpretation," suggesting it's designed to replace or provide an objective alternative to subjective visual interpretation.

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

Yes, the studies described are essentially standalone performance studies for the ASiManager-AT device. The device's proprietary software algorithm interprets the agglutination pattern and determines results independently, which are then compared to the ground truth established by human visual interpretation.

7. The Type of Ground Truth Used

The ground truth used was expert visual interpretation by "trained laboratory professionals."

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set of the ASiManager-AT's proprietary software algorithm. It only details the performance studies for validation.

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

The document does not provide information on how the ground truth for the training set was established. It only mentions that the ASiManager-AT uses a "proprietary software algorithm" that interprets the agglutination pattern based on "criteria that define reactive and nonreactive agglutination reactions." This implies that historical data, expert knowledge, or other methods were used to train the algorithm and define these criteria.

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