(269 days)
The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus.
The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.
PixoTest® POCT System consists of the following devices:
- PixoTest® POCT Analyzer
Include:
- PixoHealth POCT A1c App
- USB Charger
- USB Type C Charge Cable
- PixoTest POCT Calibration Card
- PixoTest® POCT A1c Test Kit
Include:
- A1c Test Strip
- Spoit with Latex-Tablet
- Buffer Solution Tube
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
Device: PixoTest® POCT System - PixoTest® POCT Analyzer and PixoTest® A1c Test Kit
Intended Use: Quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus. Intended for clinical laboratory and Point-of-Care Professional use.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list specific quantitative acceptance criteria values prior to the study for each performance metric, but it does state that the study results "demonstrate that the accuracy specifications... meet the acceptance criteria." The study focused on accuracy compared to a laboratory reference method.
| Performance Metric | Acceptance Criteria (Implied / Stated Goal) | Reported Device Performance (Study Results) |
|---|---|---|
| Accuracy | Meets accuracy specifications. | Study demonstrated that accuracy specifications were met. (No specific numerical results/tables are provided in this summary, only the qualitative statement of meeting criteria). |
Note: For a full regulatory submission, specific acceptance criteria for accuracy (e.g., bias, precision measured by CV%, correlation coefficient R^2, Bland-Altman agreement with reference method, allowable total error) would typically be defined and presented numerically. This summary only provides a high-level conclusion.
2. Sample Size and Data Provenance
- Test Set Sample Size: 120 subjects
- Data Provenance: The location of data collection is not explicitly stated as a country but it was collected at "3 point-of-care sites." It's reasonable to infer these are clinical sites that conducted the study. The study appears to be prospective as it involved collecting samples from subjects for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
- This device is an in-vitro diagnostic (IVD) for measuring HbA1c, not a diagnostic imaging AI. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for images) does not directly apply.
- Ground Truth Establishment: The ground truth for the test set was established by comparison with a laboratory reference instrument. In this case, it was the "TOSOH G7 Analyzer lab instrument." This is a standard approach for IVD device validation, where a known, highly accurate, and often predicate or gold-standard laboratory method serves as the reference. Qualified laboratory personnel, following validated procedures, operate such reference instruments.
4. Adjudication Method for the Test Set
- As this is an IVD device measuring an analyte (HbA1c) against a reference instrument, an "adjudication method" in the sense of multiple human readers resolving disagreements (e.g., 2+1, 3+1) is not applicable. The comparison is quantitative between the new device and the reference laboratory instrument.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with AI vs. without AI assistance) is relevant for AI-powered diagnostic imaging devices where human interpretation is part of the clinical workflow.
- The PixoTest POCT system is an automated in-vitro diagnostic device that provides a quantitative measurement. It does not involve human "reading" or a human-in-the-loop AI assistance model in the way an imaging AI would.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The core of the clinical evaluation was to compare the performance of the PixoTest POCT Analyzer and PixoTest A1c Test Kit (the device itself) against a well-established laboratory reference method (TOSOH G7 Analyzer).
- The study "comparing venous whole blood A1c values on the PixoTest POCT Analyzer and PixoTest A1c Test Kit with values on TOSOH G7 Analyzer lab instrument" directly assesses the standalone analytical performance of the device.
7. Type of Ground Truth Used
- Reference Laboratory Instrument / Expert Consensus on Reference Method: The ground truth was established by values obtained from a TOSOH G7 Analyzer lab instrument. This represents a highly accurate and accepted reference method for HbA1c measurement in a clinical laboratory setting, effectively serving as the "gold standard" or expert consensus (via established, validated methodology). It's not pathology (histology), or direct outcomes data, but rather a robust, analytical measurement from a validated reference device.
8. Sample Size for the Training Set
- The document does not provide information regarding the sample size of a training set. This is typical for regulatory summaries of IVD devices where the underlying technology (reflectance photometry, immunoassay) relies on established principles of analytical chemistry and does not inherently involve complex data-driven "training" in the machine learning sense that would require a large, labeled training dataset of the same type as the test set. While there might be internal algorithm development and calibration data, it is not described as a "training set" in the context of a typical AI/ML submission, nor is its size reported here.
9. How the Ground Truth for the Training Set Was Established
- Given that a "training set" (in the AI/ML context) is not explicitly discussed for this device, the method for establishing its ground truth is not provided.
- For IVD devices like this, calibration and validation during development typically involve using reference materials, calibrators, and control materials with known concentrations, traceable to international standards if applicable. These values are established through rigorous analytical methods by reference laboratories or manufacturers.
§ 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).