(446 days)
The Primus A1care Assay A1c test, for use with the TRI•stat™ Instrument, is a rapid in vitro diagnostic test for measurement of the percent of glycated hemoglobin (%HbA1c) level in human blood from finger stick or venous samples for clinical laboratory and point-of-care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.
The Primus TRI•stat™ Instrument is a small (10"Wx11"Lx4"H), in vitro diagnostic instrument used with the Primus A1care Assay test to quantitate HbA1c using a patented two-phase optical method. The TRI•stat™ is capable of analyzing a total of 3 samples simultaneously.
The provided document is a 510(k) summary for the Primus TRI•stat™ Instrument and A1Care Assay, indicating substantial equivalence to a predicate device (K891235, Primus Boronate Affinity HPLC Method). However, it does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a comprehensive study report.
The document primarily focuses on establishing equivalent intended use, technology, and performance to the predicate device. It states: "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies. These studies demonstrate that the instrument and test substantially equivalent to the predicate device and are safe and effective for their intended use."
Without the actual study reports, the following information cannot be extracted:
Here's a table based on the information not available in the provided document, indicating what would typically be requested for such a description:
Acceptance Criteria and Device Performance (Not Provided in Document)
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy / Bias | Not specified | Not specified |
| Precision (Within-run, Between-run, Total) | Not specified | Not specified |
| Linearity / Measuring Range | Not specified | Not specified |
| Interference | Not specified | Not specified |
| Method Comparison (vs. Predicate/Reference Method) | Not specified | Not specified |
| Correlation Coefficient (R) | Not specified | Not specified |
| Regression Equation (Slope, Intercept) | Not specified | Not specified |
Here's a breakdown of the other requested information, indicating what is available and what is not:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the provided document. The document only mentions "comprehensive studies."
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
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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 as the device measures a quantitative biomarker (HbA1c). Ground truth for such devices is typically established through reference methods or certified reference materials, not expert consensus in the diagnostic imaging sense. The document implies comparison to the predicate device (Primus Boronate Affinity HPLC Method) and "known standards."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a quantitative diagnostic assay. Performance is assessed by statistical comparison to a reference method or certified values.
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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 a standalone in-vitro diagnostic instrument for measuring a biomarker, not an AI-assisted diagnostic imaging device that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the TRI•stat™ Instrument and A1Care Assay as standalone in-vitro diagnostic device. It quantifies HbA1c using a "patented two-phase optical method." While the instrument is "Partially Automated" and "Requires Sample Insertion and Tube Insertion," the measurement and result generation appear to be fully automated once the sample is loaded. Therefore, performance evaluation would be standalone. The document states "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies that performance is benchmarked against "known standards" and the predicate device (Primus Boronate Affinity HPLC Method). For HbA1c measurements, ground truth would typically be established by:
- Reference methods: Such as HPLC methods (like the predicate device) or methods traceable to IFCC reference systems.
- Certified reference materials: Samples with known, validated HbA1c concentrations.
- The document implies that performance is benchmarked against "known standards" and the predicate device (Primus Boronate Affinity HPLC Method). For HbA1c measurements, ground truth would typically be established by:
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The sample size for the training set
- Not specified. The document does not describe the development or training of any machine learning model, only the evaluation of the full device. It mentions "factory calibrated" for optical measurements, which implies internal calibration data but not a distinct "training set" in the context of machine learning.
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How the ground truth for the training set was established
- Not applicable as no specific "training set" for a machine learning model is mentioned. Calibration and performance are likely based on reference materials and comparisons to established methods.
§ 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).