(36 days)
Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Data Connectivity Converter (ADCC) is a small device for automatic transfer of data. including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system or another electronic journal system.
Afinion™ AS100 Analyzer System, consisting of Afinion™ AS100 Analyzer with Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only.
Afinion™ HbAIc is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin Alc. % HbA Ic) in human whole blood. The measurement of % HbA Ic is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.
Afinion™ HbA Ic Controls have been designed for use with the Afinion™ ASI00 Analyzer System. Quality control using the Afinion™ HbA Ic Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable result.
The 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 Afinion™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.
The Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Afinion™ ASI00 Analyzer System is working properly and provides reliable results.
The Afinion™ AS100 Analyzer is equipped with a new component/accessory: A finion™ Data Connectivity Converter (ADCC). The ADCC is only for use together with the Afinion™ AS100 Analyzer.
The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system (LIS) or another electronic journal system. It converts the format of the results from the proprietary Afinion™ Analyzer protocol to a standardized protocol (HL7 or ASTM). The main functionality for software contained in the Afinion™ Data Connectivity Converter is to:
- . Extract test result data from the Afinion™A$100 Analyzer
- . Convert the transmission format to a configurable standard protocol and forward the result data on Ethernet
- Provide user feedback on LEDs .
- Provide user interface for configuration and software upgrade through a web . interface
- Provide functionality to reset device to default/factory software status. .
The provided document describes a Special 510(k) Summary for a modification to the Afinion™ AS100 Analyzer, specifically the addition of the Afinion™ Data Connectivity Converter (ADCC). This document focuses on the safety and efficacy of the ADCC and its integration with the existing cleared device.
Crucially, the document does not contain acceptance criteria, reported device performance data, or detailed study results for the ADCC's performance in terms of diagnostic accuracy or clinical effectiveness. The study information provided is limited to design control activities and compliance with electrical and electromagnetic compatibility (EMC) standards.
Therefore, many of the requested sections below cannot be populated with information from the provided text.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for the ADCC. The acceptance criteria mentioned are related to successful completion of design control activities and compliance with safety and EMC standards.
- Reported Device Performance: The document confirms the ADCC was tested and found to be in conformity with various electrical safety and EMC standards. It does not report performance data like data transfer speed, error rates, or successful connection rates, which would be typical performance metrics for a data connectivity device.
| Acceptance Criteria Category | Specific Criteria (as inferred/stated) | Reported Device Performance |
|---|---|---|
| Design Development | Design Plan adherence | Agreement with design input/specifications |
| Software Testing | Code reviews, module testing, functional testing | Performed and considered in agreement with design input/specifications |
| Hazard Analysis | No unacceptable risks identified | Performed; no unacceptable risks found |
| Electrical Safety | Conformity with IEC 61010-1, IEC 61010-2-081, IEC 61010-2-101 | Tested and found to be in conformity |
| EMC Standards | Conformity with EN 61326-1, EN 61326-2-6, CFR 47 Part 15 Subpart B | Tested and found to be in conformity |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a clinical "test set" or diagnostic performance study for the ADCC. The testing mentioned refers to engineering verification and validation activities (software testing, electrical safety, EMC). Therefore, no sample size or data provenance is provided for a diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The document does not describe a study involving expert-established ground truth for a diagnostic test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The document does not describe a diagnostic test set requiring adjudication.
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
- Not applicable. This is not an AI-assisted diagnostic device, but a data connectivity converter for an existing IVD analyzer. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable for diagnostic performance. While the ADCC itself functions automatically to transfer data, its "standalone performance" is described in terms of its technical functionality (extracting, converting, forwarding data) and compliance with relevant technical and safety standards, not diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for diagnostic performance. For the engineering tests mentioned, the "ground truth" would be adherence to specified technical requirements and industry standards.
8. The sample size for the training set
- Not applicable. This document pertains to a hardware and software accessory for data transfer, not a machine learning or AI algorithm development that would involve a "training set" in the conventional sense.
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.
§ 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).