(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.
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Image /page/0/Picture/0 description: The image shows the word "MEDISENSE" in bold, black letters. To the left of the word is a black graphic that looks like three stacked, tilted rectangles. A circled R symbol is located to the right of the word.
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JIN 21 189
MediSense, Inc.
266 Second Avenue
Waltham, MA 02154
Telephone: 617.895.6000
Fax: 617.890.1711
510(k) Summary
| Submitter/Contact Person: | Michael Halpin, Manager Regulatory and Clinical AffairsMediSense, Inc.266 Second AvenueWaltham, MA 02154Telephone: #617-895-6289Fax: #617-890-1711 |
|---|---|
| Date Prepared: | April 18, 1996 |
| Device Name: | ExacTech RSG Blood Glucose Testing System |
| Common Name: | Blood Glucose Test System |
| Classification: | "Glucose Test System" - Class II per CFR 862.1345 |
| Predicate Devices: | ExacTech Blood Glucose Testing System - K863468 |
| Description: | The ExacTech RSG Blood Glucose Testing System utilizes amperometricbiosensor technology to quantitatively measure glucose in whole blood andcontrol solutions. After inserting a test strip into the sensor, a drop of wholeblood or control solution is applied to the target area of the test strip and thesensor button is pressed. A countdown begins and glucose oxidase catalyzesthe oxidation of glucose to produce gluconic acid. During the reaction,electrons are transferred by an electrochemical mediator to the electrodesurface, 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 thesample, thus giving an accurate reading of glucose concentration after 30seconds. |
| Intended Use: | The ExacTech RSG Blood Glucose Testing System is intended for in vitrodiagnostic use (i.e., for external use only) for the quantitative measurement ofglucose in fresh capillary whole blood. The product is designed for home orprofessional use. |
| Comparison toPredicate Device: | The ExacTech RSG Blood Glucose Testing System has technologicalcharacteristics equivalent to those of the predicate ExacTech Blood GlucoseTesting System.The hardware for the ExacTech RSG Sensor has been revised compared to thepredicate ExacTech Sensor to improve user features such as ease of test stripinsertion, ease of test initiation and display readability. The software for theExacTech RSG Sensor has been revised compared to the predicate ExacTechsoftware to include pre-programmed universal calibration informationeliminating the need for a calibration procedure. |
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The only design difference between the new ExacTech RSG test strips and the predicate ExacTech test strips is the method of calibration. ExacTech RSG test strips do not require a user calibration procedure because the sensor is preprogrammed with universal calibration information specific to ExacTech RSG test strips.
Performance Studies:
Comparative nonclinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System included linearity and dynamic range testing. The performance of the ExacTech RSG System was determined to be comparable to the performance of the standard ExacTech System.
Comparative clinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System was performed at three sites and included a clinic, physician's office, and clinical research center. A total of 178 subjects (34% male, 66% female) ranging in age from 9 to 88 years participated in the study. The majority of participants were either White or Hispanic. A diversity of both education and occupation was observed at all sites. Two of the sites had a higher percentage of subjects with NIDDM and one site had a higher percentage of subjects with IDDM.
To evaluate accuracy, capillary whole blood was collected from each subject and tested by a trained operator on both the new ExacTech RSG and standard ExacTech Systems, as well as a YSI Analyzer. Results for the three sites are summarized below and indicate that the accuracy of the ExacTech RSG System is comparable to the accuracy of the standard ExacTech System.
| ExacTech RSGSystem | Standard ExacTechSystem | |
|---|---|---|
| Correlation Coefficient (r) | 0.979 | 0.983 |
| Slope (m), mg/dL | 0.971 | 0.925 |
| Y-intercept, mg/dL | 2.2 | 4.7 |
| N | 288 | 170 |
To evaluate precision, venous whole blood was tested twenty times on both the new ExacTech RSG and standard ExacTech Systems. Results obtained at one of the sites are summarized below and indicate that the precision of the ExacTech RSG System is comparable to the precision of the standard ExacTech System.
| ExacTech RSG System | Standard ExacTech System | ||||
|---|---|---|---|---|---|
| Mean,mg/dL | SD,mg/dL | CV,% | Mean,mg/dL | SD,mg/dL | CV,% |
| 59.1 | 3.03 | 5.1 | 53.1 | 3.77 | 7.1 |
| 89.2 | 3.59 | 4.0 | 87.9 | 5.07 | 5.8 |
| 175.6 | 7.37 | 4.2 | 143.8 | 9.77 | 6.8 |
| 297.5 | 8.57 | 2.9 | 268.0 | 9.36 | 3.5 |
Conclusion:
Results of comparative nonclinical and clinical testing demonstrate that the performance of the ExacTech RSG Blood Glucose Testing System is comparable to the performance of the standard ExacTech Blood Glucose Testing System and suitable for its intended use.
§ 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.