Search Results
Found 1 results
510(k) Data Aggregation
(184 days)
The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for all ages (excluding neonates.) It is intended for use outside the body (for in vitro diagnostic use) by health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs) as an aid to monitor the effectiveness of diabetes control.
The Q.STEPS™ Biometer G Blood Glucose Monitoring System is an in vitro device designed for measuring the concentration of glucose in capillary whole blood from the fingertip. The system uses electrochemical methodology. The system quantifies glucose amperometrically by measuring the current that is produced when glucose oxidase catalyzes the oxidation of glucose to gluconic acid. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and is converted to a readout displayed on the monitor.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Q.STEPS™ Biometer G Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicitly Stated or Implied by Context) | Reported Device Performance |
|---|---|---|
| Linearity | Good linearity through a wide range (implied to be clinically relevant for glucose monitoring) | Good through a wide range of 50 to 400 mg/dl. Confirmed with internal laboratory and external clinical studies. |
| Accuracy (Agreement with Reference Method) | Bias within 20 mg/dl (for Blood Glucose < 100 mg/dl) or within 20% (for Blood Glucose ≥ 100 mg/dl) on the reference method. >95% (or similar high percentage) in Zones A & B of Clarke Error Grid. | All data collected fall well within the acceptance criteria of a bias within 20 mg/dl (Blood Glucose < 100 mg/dl) or within 20% (Blood Glucose ≥ 100 mg/dl) on the reference method. Over 98% of all clinical data fall into acceptable zones A & B in the Clarke Error Grid analysis. |
| Precision (CV Values) | CV values well within 8% (for commercial controls and spiked venous whole blood specimens). | Standard deviation values are very low and CV values are well within the acceptance criteria of less than 8%. |
| Stability (Shelf Life of Test Strips) | Provides constant glucose reading over time for its intended shelf life. | Test strips provide a constant glucose reading over time. Accelerated stability evaluation determines an approximate shelf life of 2 years. |
| Hematocrit Interference | Within ±20% of the glucose concentration determined with a set of hematocrit standard (45±3%). | Hematocrit levels of 30% to 60% are acceptable for use with the system, meeting the acceptance criteria of ±20% of the glucose concentration determined with a set of hematocrit standard (45±3%). |
| Interference Substances | No interference observed at physiological/therapeutic levels for common substances. Limited or no interference observed at higher dosages where clinically acceptable. | No interference observed in Bilirubin, Cholesterol, Creatinine, Citrate (at physiological levels, except Uric Acid), Ibuprofen, Aspirin, Tetracycline, EDTA, D-Galactose, K3Fe(CN)6, D-Mannose, D-Xylose, and Maltose. Some interference observed at higher dosages of Acetaminophen, Ascorbic Acid, L-Dopa, Dopamine, Methyldopa, and Tolazamide, but implied to be acceptable within context. |
| Safety | No adverse health effects observed. | No adverse health effects were observed in the pre-clinical & clinical study. No post-clinical trial reports of any health effect were seen. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Accuracy: Not explicitly stated as a single number. The document mentions "clinical trial method comparison studies" and "all clinical data," but doesn't provide a specific number of subjects or samples tested for accuracy.
- Precision:
- Commercial Controls: 2 runs/day x 2 readings/run x 2 biometers x 20 days = 160 readings per control level. (Number of control levels not specified).
- Venous Whole Blood: 20 readings per concentration for five different concentrations. So, 20 readings x 5 concentrations = 100 readings.
- Hematocrit Interference: Not explicitly stated; mentions "tested within the hematocrit range from 30% to 60%" and "a set of hematocrit standard (45±3%)."
- Interference Substances: "Twenty-three commonly tested interference substances were examined." The number of samples per substance is not stated.
- Linearity & Stability: No specific sample sizes provided.
- Data Provenance: The document does not specify the country of origin. The studies involve both "internal laboratory" and "external clinical studies/trial." This suggests a combination of prospective (clinical trials) and retrospective (internal lab data, possibly from existing samples) data, but the specific breakdown is unclear.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. The document describes accuracy relative to a "reference laboratory method," but does not mention human experts establishing ground truth or their qualifications.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for establishing ground truth. The ground truth for glucose measurements is established by a reference instrument (YSI 2300 STST Glucose/Lactate Analyzer), not through expert adjudication of images or clinical cases.
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
- A Multi-reader Multi-case (MRMC) comparative effectiveness study is not applicable and was not performed as this device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that aids human readers in interpreting results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance studies described are for the device (Q.STEPS™ Biometer G Blood Glucose Monitoring System) operating in a standalone mode (algorithm only) measuring glucose concentrations. While a human uses the device and interprets the displayed result, the performance metrics (accuracy, precision, linearity, etc.) refer to the direct output of the instrument compared to a reference standard, without any human interpretation influencing the measurement itself.
7. The Type of Ground Truth Used
- The ground truth for glucose concentration measurements was established by a reference laboratory method, specifically the Yellow Spring Instrument (YSI) 2300 STST Glucose/Lactate Analyzer.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning or AI. This device relies on electrochemical principles and a pre-defined algorithm, not a trainable machine learning model. Therefore, the concept of a training set for an AI algorithm is not applicable here. The internal laboratory studies and initial development likely involved various samples to calibrate and refine the device's measurement algorithm, but these are not explicitly referred to as a "training set."
9. How the Ground Truth for the Training Set Was Established
- As the device does not employ a machine learning algorithm with a "training set" in the conventional sense, this question is not applicable. The underlying physical and chemical principles and algorithms are based on established scientific methods for glucose detection, and the "ground truth" during development/calibration would have been established using highly accurate reference methods like the YSI 2300 or similar laboratory-grade analyzers.
Ask a specific question about this device
Page 1 of 1