(74 days)
The ExacTech RSG Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The product is designed for home or professional use.
The ExacTech RSG Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. After inserting a test strip into the sensor, a drop of whole blood or control solution is applied to the target area of the test strip and the sensor button is pressed. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the ExacTech RSG Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 30 seconds.
This document describes the performance of the ExacTech RSG Blood Glucose Testing System compared to the predicate ExacTech Blood Glucose Testing System and a YSI Analyzer. The information provided is for regulatory submission and focuses on equivalence rather than specific acceptance criteria against a fixed benchmark.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with numerical targets for the ExacTech RSG system. Instead, it aims to demonstrate comparability to the predicate device and a YSI Analyzer. The performance metrics presented are for comparison purposes.
| Performance Metric | Acceptance Criteria (Implicit: Comparable to Predicate/YSI) | ExacTech RSG System Performance | Standard ExacTech System Performance | YSI Analyzer (Reference, for accuracy) |
|---|---|---|---|---|
| Accuracy | Correlation Coefficient (r) comparable to predicate & YSI | 0.979 | 0.983 | N/A (YSI is the reference) |
| Slope (m) comparable to predicate & YSI | 0.971 mg/dL | 0.925 mg/dL | N/A | |
| Y-intercept comparable to predicate & YSI | 2.2 mg/dL | 4.7 mg/dL | N/A | |
| Precision | Mean, SD, CV% comparable to predicate | See table below | See table below | N/A |
| Precision (Example 1) | Mean comparable to predicate | 59.1 mg/dL | 53.1 mg/dL | N/A |
| SD comparable to predicate | 3.03 mg/dL | 3.77 mg/dL | N/A | |
| CV% comparable to predicate | 5.1% | 7.1% | N/A | |
| Precision (Example 2) | Mean comparable to predicate | 89.2 mg/dL | 87.9 mg/dL | N/A |
| SD comparable to predicate | 3.59 mg/dL | 5.07 mg/dL | N/A | |
| CV% comparable to predicate | 4.0% | 5.8% | N/A | |
| Precision (Example 3) | Mean comparable to predicate | 175.6 mg/dL | 143.8 mg/dL | N/A |
| SD comparable to predicate | 7.37 mg/dL | 9.77 mg/dL | N/A | |
| CV% comparable to predicate | 4.2% | 6.8% | N/A | |
| Precision (Example 4) | Mean comparable to predicate | 297.5 mg/dL | 268.0 mg/dL | N/A |
| SD comparable to predicate | 8.57 mg/dL | 9.36 mg/dL | N/A | |
| CV% comparable to predicate | 2.9% | 3.5% | N/A |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Accuracy Study):
- Number of subjects: 178
- Number of measurements (ExacTech RSG): 288
- Number of measurements (Standard ExacTech): 170 (This discrepancy between subject count and measurements for the standard system is noted, but not explained in the text. It's possible some subjects had fewer measurements with the standard system, or only a subset of measurements were included in this specific summary.)
- Data Provenance: The study was conducted at "three sites" which included "a clinic, physician's office, and clinical research center." The text does not specify the country of origin. The study appears to be prospective as it involved recruiting subjects and collecting fresh capillary whole blood for testing.
- Demographics: 34% male, 66% female, age 9-88 years. Majority were White or Hispanic, with diversity in education and occupation. Two sites had a higher percentage of NIDDM (Non-Insulin Dependent Diabetes Mellitus) and one site had a higher percentage of IDDM (Insulin Dependent Diabetes Mellitus).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The ground truth for the clinical accuracy study was established using a YSI Analyzer. This is a laboratory-grade instrument considered a gold standard for glucose measurement, not human experts. Therefore, the question of "number of experts" and "qualifications" doesn't directly apply here in the traditional sense of image interpretation or medical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was an objective measurement from a YSI Analyzer, not a subjective assessment requiring adjudication.
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 not an AI-assisted diagnostic device; it is a blood glucose monitoring system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" do not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The performance studies evaluate the device's performance (ExacTech RSG System). While a trained operator performed the test, the focus of the data presented is on the system's accuracy and precision in measuring glucose, which is an automated process once the blood is applied to the strip. The "algorithm" here refers to the internal workings of the amperometric biosensor technology to quantitatively measure glucose.
7. The Type of Ground Truth Used
The ground truth used for the clinical accuracy study was objective measurements from a predicate laboratory-grade instrument (YSI Analyzer). This is considered a highly accurate and reliable method for blood glucose determination.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" in the context of machine learning or AI models. This device relies on established biosensor technology. The "pre-programmed universal calibration information" suggests that this calibration data (which could be considered analogous to a training set for a traditional calibration model) was established internally by the manufacturer, but its specific sample size is not disclosed.
9. How the Ground Truth for the Training Set Was Established
As discussed above, a specific "training set" in the AI sense is not described. The device uses "pre-programmed universal calibration information." This calibration would have been established by the manufacturer through rigorous testing of the ExacTech RSG test strips against a reference method (likely a YSI Analyzer or similar laboratory standard) to define the relationship between the electrochemical signal and glucose concentration. Details on the exact process or sample size for this internal calibration are not provided in the summary.
§ 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.