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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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