(169 days)
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.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).