(501 days)
The IWL2020 Blood Glucose Monitoring System is comprised of the IWL2020 meter and IWL2020 test strips. The IWL2020 Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip as an aid in monitoring the effectiveness of glucose control.
The IWL2020 Blood Glucose Monitoring System is intended for in vitro diagnostic single patient use by people with diabetes at home.
The IWL2020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
The IWL2020 Blood Glucose Monitoring System consists of the following components:
- IWL2020 Meter
- IWL2020 Blood Glucose Test Strips
- IWL2020 Control Solutions
The IWL2020 Blood Glucose Monitoring System is a handheld device that incorporates features to aid in self-monitoring of blood glucose. The blood glucose results are displayed on the screen and stored in the meter's memory, and may also be transmitted via Bluetooth Low Energy (BLE) wireless communication. Our blood glucose monitoring system creates a glucose result from an amperometric reaction. Capillary whole blood from the user's fingertip reacts with the chemicals in the test strip to create a harmless electrical current in the test strip. The blood glucose meter reads the current and gives a blood glucose result.
The provided text describes the acceptance criteria and a study to prove that the device (IWL2020 Blood Glucose Monitoring System) meets these criteria. The study focuses on demonstrating the substantial equivalence of the IWL2020 system to a legally marketed predicate device (Accu-Chek Guide Blood Glucose Monitoring System).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text outlines performance metrics rather than explicitly listing acceptance criteria as a separate table. However, the "Clinical Performance" section presents accuracy targets which can be interpreted as acceptance criteria based on standard glucose monitoring device expectations.
| Acceptance Criteria (Accuracy vs. Lab Reference) | Reported Device Performance (IWL2020 Blood Glucose Monitoring System) |
|---|---|
| Within ±20% of laboratory reference | 99% (346 of 350 results) |
| Within ±15% of laboratory reference | 96% (336 of 350 results) |
| Within ±10% of laboratory reference | 88% (307 of 350 results) |
| Within ±5% of laboratory reference | 63% (220 of 350 results) |
Additional Non-Clinical Performance Criteria and Results (from "Non-Clinical & Clinical Testing Summary and Conclusions"):
- Measurement Range: 20-600 mg/dL (Supported by Linearity Evaluation)
- Precision (Within-Run Evaluation):
- Glucose Level 1 (20 mg/dL): 1.1 mg/dL SD
- Glucose Level 2 (40 mg/dL): 1.2 mg/dL SD
- Glucose Level 3 (80 mg/dL): 1.8 mg/dL SD
- Glucose Level 4 (130 mg/dL): 2.1 %CV
- Glucose Level 5 (200 mg/dL): 2.3 %CV
- Glucose Level 6 (325 mg/dL): 2.7 %CV
- Glucose Level 7 (450 mg/dL): 2.6 %CV
- Glucose Level 8 (550 mg/dL): 2.6 %CV
- Precision (Intermediate Precision Evaluation):
- Glucose Level 1 (27.8 mg/dL): 1.3 mg/dL SD
- Glucose Level 2 (44.4 mg/dL): 1.3 mg/dL SD
- Glucose Level 3 (113.6 mg/dL): 2.6 %CV
- Glucose Level 4 (291.9 mg/dL): 2.3 %CV
- Glucose Level 5 (495.1 mg/dL): 2.0 %CV
- Glucose Level 6 (541.4 mg/dL): 2.2 %CV
- Linearity (R-squared for All Lots): 0.9985 (indicating strong linearity across the measurement range)
- Interference: All compounds met acceptance criteria except abnormally high concentrations of ascorbic acid (> 5 mg/dL) and xylose.
- Flex Studies: System operated within specified ranges and displayed errors correctly when outside operating ranges.
- Electromagnetic Interference and Electrical Safety: Passed according to national and international standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance Test Set: 350 results (implicitly, as 346/350, 336/350, etc., are reported).
- Data Provenance:
- Country of Origin: United States.
- Retrospective or Prospective: Prospective. The text states: "A clinical (user evaluation) study was conducted with IWL2020 Blood Glucose Monitoring System in the intended user population, i.e. lay persons who perform self-testing using capillary whole blood, in the United States." This implies a specifically designed study for evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The text states the clinical performance was "compared to the Roche/Hitachi cobas c 501 PCA-HK reference method." It also mentions "blood glucose readings obtained by trained technicians."
- This suggests the ground truth was established by a laboratory reference method, operated by "trained technicians." The number and specific qualifications (e.g., years of experience) of these technicians, or the experts overseeing the laboratory method, are not explicitly stated.
4. Adjudication Method for the Test Set
- The text does not mention any adjudication method (e.g., 2+1, 3+1) for the clinical performance data. The comparison is directly between the device readings and the laboratory reference method readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed as described.
- The study was a user evaluation (clinical performance) to assess how well "non-professional, inexperienced lay persons" obtained accurate readings with the IWL2020 system compared to a laboratory reference. It does not compare human readers with AI assistance versus without AI assistance. The IWL2020 is a blood glucose monitoring system, not an AI-powered image analysis tool for diagnostic imaging, which is where MRMC studies are typically applied.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- The primary clinical performance study described is the user evaluation, which involves "lay persons who perform self-testing." This inherently includes human-in-the-loop performance.
- However, the "Non-Clinical & Clinical Testing Summary and Conclusions" section also includes various non-clinical evaluations (e.g., Within-Run Precision, Intermediate Precision, Linearity, Interference, Flex Studies, Electromagnetic Interference, Electrical Safety). These tests assess the device's technical performance in a controlled setting, which can be seen as standalone testing of the algorithm/device's core functionality, without user variability being the primary focus. Specifically, the "System Accuracy" refers to the accuracy of the device's readings when compared to a reference method, which is an assessment of the device's inherent capability.
7. Type of Ground Truth Used
- Laboratory Reference Method: The ground truth for the clinical performance study was established using the "Roche/Hitachi cobas c 501 PCA-HK reference method." This is a highly accurate laboratory instrument.
8. Sample Size for the Training Set
- The document describes testing and validation, but it does not explicitly state the sample size used for a training set. Blood glucose monitoring systems typically derive their algorithms from fundamental electrochemical principles and calibrations, rather than machine learning models that require distinct training sets in the same way as, for example, an AI imaging diagnostic tool. The "linearity evaluation" used blood samples from eleven glucose concentration levels run on 36 IWL2020 meters using strips from three lots, which would contribute to the device's calibration or "training" in a broad sense, but not in the context of a 'training set' for a deep learning model.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned in the context of a machine learning model, the method for establishing its ground truth is not detailed. For the device's fundamental calibration and performance, the "linearity evaluation" involved preparing blood samples at "eleven blood glucose concentration levels." These concentrations would typically be precisely measured by a highly accurate laboratory reference method (like the Roche/Hitachi cobas c 501 PCA-HK or similar primary standards) to serve as the ground truth for establishing the device's internal calibration curve.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.