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510(k) Data Aggregation
(636 days)
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.
| Category | Acceptance Criteria (Implied by Predicate/New Specificity) | Reported Device Performance (Candidate Device - Modified Afinion™ HbA1c) |
|---|---|---|
| Analytical Specificity: Hemoglobin Variants & Derivatives | Predicate: HbAC, HbAD, HbAE, HbF, HbAJ, HbAS, Carbamylated Hb, Pre-glycated Hb do not affect result. | No significant interference (≤ 7%) observed for samples with hemoglobin (Hb) variants and hemoglobin derivatives up to the following concentrations: • HbA2 5.7%• HbAC 36%• HbAD 42%• HbAE 26%• HbAS 42%• HbF 10.4%• Acetylated Hb 4.6 mg/mL• Carbamylated Hb 13.8 mg/mL• Labile (pre-glycated) Hb 11.4 mg/mL |
| Limitations (HbF) | Predicate: No HbF limitation. | The highest HbF concentration where no significant interference (≤ 7%) is observed is 10.4% HbF. Above 10.4% HbF, a negative interference is observed. |
| Limitations (Sample Condition) | Predicate: Do not analyze hemolyzed or coagulated samples. | Coagulated or hemolyzed samples cannot be used with Afinion™ HbA1c. Samples with >14% (2000 mg/dL) hemolysis may return an information code. |
| Interference (Endogenous/Exogenous Substances) | Predicate: No significant interference (<5%) up to specified concentrations for Bilirubin, Triglycerides, Cholesterol, Glucose, Fructosamine, Hemolysis, Anticoagulants, Acetaminophen, Ibuprofen, Acetylsalicylic acid, Salicylic acid, Glyburide, Metformin. | No significant interference (≤7%) was observed up to the following concentrations: • Bilirubin conjugated 600 mg/L• Bilirubin unconjugated 600 mg/L• Glucose 10 g/L• Lipids (as Intralipid) 10 g/L• Rheumatoid factor 780 000 IU/L• Total protein 15 g/dL• Glycated albumin 7.7 g/L• Acetaminophen 200 mg/L• Acetylcysteine 1663 mg/L• Acetylsalicylic acid 1000 mg/L• Ampicillin 1000 mg/L• Ascorbic acid 300 mg/L• Cefoxitin 2500 mg/L• Cyclosporine A 5 mg/L• Cyclosporine C 5 mg/L• Doxycycline 50 mg/L• Glyburide 1.9 mg/L• Heparin 5000 U/L• Ibuprofen 500 mg/L• Levodopa 20 mg/L• Metformin 40 mg/L• Methyldopa 20 mg/L• Metronidazole 200 mg/L• Phenylbutazone 400 mg/L• Rifampicin 64 mg/L• Salicylic acid 599 mg/L• Theophylline 100 mg/L• Hemolysis (in vitro) 14 %• Anticoagulants (EDTA, heparin and citrate) at concentrations normally used in blood collection tubes do not interfere. |
2. Sample size used for the test set and the data provenance
The document describes analytical performance characteristics, meaning substances were tested to determine their interference with the assay. It does not mention a "test set" in the context of an AI/ML algorithm evaluation with patient data. The specifics of sample size and data provenance (country, retrospective/prospective) for these analytical studies are not provided in this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/provided. For an in-vitro diagnostic assay like Afinion™ HbA1c, the ground truth for analytical performance is established by known concentrations of substances or reference methods, not by expert consensus on clinical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving interpretation (e.g., radiology for AI/ML), which is not the nature of this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. An MRMC study is relevant for AI/ML imaging devices that assist human readers. This device is an automated diagnostic assay.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided, as this is not an AI/ML algorithm. The device "stand-alone" performance is its analytical performance as an automated assay, as detailed in the interference and specificity sections.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for this type of IVD testing would typically involve:
- Reference methods: Comparing the device's results to established, highly accurate laboratory methods for HbA1c measurement.
- Known concentrations: Spiking samples with known concentrations of interfering substances or hemoglobin variants to determine the assay's specificity and interference profile.
The document does not explicitly state the reference method used but implies the use of controlled laboratory conditions and specific substance concentrations for interference testing.
8. The sample size for the training set
This information is not applicable/provided. The Afinion™ HbA1c is a chemical assay, not an AI/ML device, and therefore does not have a "training set" in the sense of machine learning. The "training" of such a device involves assay development, reagent formulation, and calibration using established chemical and biological principles.
9. How the ground truth for the training set was established
This information is not applicable/provided. Similar to the above, as this is not an AI/ML device, there is no "training set" in the context of ground truth establishment for machine learning. The calibration and validation of the chemical assay would be based on certified reference materials and established metrological traceability.
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(31 days)
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.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance |
|---|---|---|
| Analytical Performance | Not adversely affected compared to predicate | All acceptance criteria met; analytical performance not adversely affected |
| Assay Sequence Timing | Maintained as in the predicate (AS100) | Software modifications ensured timing is maintained |
| Functionality | Same as the predicate (AS100) | Same functionality as predicate |
| User Interface | Same as the predicate (AS100) | Same user interface as predicate |
| Error Rates | Equivalent to predicate | Risk analysis showed no adverse effect on risk of erroneous results |
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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