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510(k) Data Aggregation
(187 days)
The OneTouch® Verio" "IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch® Verio" IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
OneTouch® Verio" IQ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio" "IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use.
The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio" IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
The OneTouch® Verio" Verio" IQ Blood Glucose Monitoring System consists of the OneTouch Verio" " Q Blood Glucose Meter, OneTouch® Verio" Test Strips, OneTouch® Verio" Mid and High Control Solutions, Lancing Device, Sterile Lancets and Alternative Site testing Kit (available separately). The Alternative Site Testing Kit comprises the OneTouch® Lancing Device, OneTouch® UltraSoft" Sterile Lancets, OneTouch®, Clear Cap and Instructions for Use. The OneTouch® Verio" IQ Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
The OneTouch® Verio™ IQ Blood Glucose Monitoring System was tested in accordance with ISO 15197:2003(E) to demonstrate its performance characteristics.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for system accuracy are generally defined in ISO 15197:2003(E). While the document doesn't explicitly state the "acceptance criteria" alongside the results, the provided performance data demonstrates adherence to typical standards for blood glucose meters. Often, for glucose concentrations <75 mg/dL, the results should be within ±15 mg/dL, and for concentrations ≥75 mg/dL, within ±15% or ±20%.
| Measurement Category | Acceptance Criteria (Typical ISO 15197:2003) | Reported Device Performance (OneTouch® Verio™ IQ) |
|---|---|---|
| System Accuracy for Glucose < 75 mg/dL | Within ±15 mg/dL: ≥95% | 102/102 (100.0%) within ±10 mg/dL (implies 100% within ±15 mg/dL) |
| System Accuracy for Glucose ≥ 75 mg/dL | Within ±15%: ≥95% | 487/498 (97.8%) within ±15% |
| Repeatability (Within Run Precision) | Coefficient of Variation (CV) ≤ 5% | Range of CV: 1.89% to 2.86% (for target glucose levels 40-350 mg/dL) |
| Total Precision (Control Solution Tests) | Coefficient of Variation (CV) ≤ 10% (guide) | Range of CV: 2.31% to 3.52% (for low, mid, high glucose levels) |
| User Performance (Subject, <75 mg/dL) | Within ±15 mg/dL: ≥95% | 31/31 (100%) within ±10 mg/dL by Subject (implies 100% within ±15 mg/dL) |
| User Performance (Subject, ≥75 mg/dL) | Within ±15%: ≥95% | 243/245 (99.2%) within ±15% by Subject |
| User Performance (HCP, <75 mg/dL) | Within ±15 mg/dL: ≥95% | 31/31 (100%) within ±15 mg/dL by HCP |
| User Performance (HCP, ≥75 mg/dL) | Within ±15%: ≥95% | 244/245 (99.6%) within ±15% by HCP |
| AST (Palm, <75 mg/dL) | Within ±15 mg/dL: ≥95% | 8/8 (100%) within ±10 mg/dL (implies 100% within ±15 mg/dL) |
| AST (Forearm, <75 mg/dL) | Within ±15 mg/dL: ≥95% | 7/7 (100%) within ±15 mg/dL |
| AST (Palm, ≥75 mg/dL) | Within ±15%: ≥95% | 146/154 (94.8%) within ±15% (Note: This is slightly below a strict 95%, but often acceptable given clinical context and overall performance. The 97.4% at ±20% is strong.) |
| AST (Forearm, ≥75 mg/dL) | Within ±15%: ≥95% | 127/144 (88.2%) within ±15% (This is below 95%. However, the 95.8% at ±20% suggests sufficient accuracy for clinical use.) |
2. Sample sizes used for the test set and the data provenance
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System Accuracy Test Set:
- Number of Subjects: 100
- Number of Tests: 600 (each subject tested 6 times, likely in duplicate for three test strip lots).
- Data Provenance: Not explicitly stated, but the study "was tested in accordance with ISO 15197:2003(E)" which is an international standard. Given the sponsor is "LifeScan Europe, a Div. of Cilag GmbH International, Zug, Switzerland," and the correspondent is in the UK, it is highly likely the data is from Europe/UK. It appears to be a prospective study for regulatory submission.
-
User Performance Evaluation Test Set:
- Number of Subjects: Not explicitly stated as a single number, but there are "Subject" (intended users) results totalling 276 measurements (<75 mg/dL: 31, ≥75 mg/dL: 245) and "HCP" results totalling 276 measurements (<75 mg/dL: 31, ≥75 mg/dL: 245). This implies at least 31 data points for glucose <75 mg/dL and 245 for glucose ≥75 mg/dL for both subject and HCP users.
- Data Provenance: Not explicitly stated, but likely from the same geographical region as the system accuracy study. It is a prospective user study.
-
Alternate Site Testing (AST) Test Set:
- Palm Site: 8 measurements (<75 mg/dL), 154 measurements (≥75 mg/dL).
- Forearm Site: 7 measurements (<75 mg/dL), 144 measurements (≥75 mg/dL).
- Data Provenance: Not explicitly stated, but likely from the same geographical region as the system accuracy study. It is a prospective user study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that the device was compared to a "laboratory reference method, the Yellow Springs Instrument (YSI)." This is a laboratory-grade analyzer, highly accurate and commonly used as a gold standard for blood glucose measurement. The ground truth is established by this instrument, not by human experts. Therefore, the number and qualifications of experts in this context are not applicable.
4. Adjudication method for the test set
Not applicable. The ground truth is a direct measurement from a YSI laboratory analyzer, which is a quantitative and objective measurement. There is no human interpretation or adjudication involved in establishing the ground truth for glucose values.
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 a blood glucose monitoring system, not an AI-assisted diagnostic imaging device with human readers. The device performs a direct measurement of glucose.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the "System Accuracy" section represents the standalone performance of the device (meter and strips) compared against the YSI laboratory reference method. The "User Performance Evaluation" sections then assess the performance when humans (subjects/HCPs) use the device, which includes the human-in-the-loop aspect of sample collection and meter operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for system accuracy and user performance evaluation is the Yellow Springs Instrument (YSI), which is a highly accurate and established laboratory reference method for glucose measurement. This falls under a "reference standard" or "gold standard" laboratory method.
8. The sample size for the training set
The document does not explicitly state the sample size for a "training set." This device is a blood glucose meter, and its performance is based on electrochemical principles and calibration. While the device would undergo internal calibration and development, the concept of a "training set" as understood in machine learning is not directly applicable or reported in this type of regulatory submission for a traditional in-vitro diagnostic device. Analytical and clinical performance studies are typically validation sets.
9. How the ground truth for the training set was established
As there is no distinct "training set" reported in the machine learning sense, this question is not fully applicable. However, for the underlying calibration and development of the device, similar reference methods (like YSI) would be used to ensure the meter's accuracy across various glucose concentrations, ensuring it correctly translates electrochemical signals into glucose readings.
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