(206 days)
The Rightest Professional Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood. The Rightest Professional Blood Glucose Monitoring System GM720 is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Rightest Professional Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for testing neonate blood samples. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Professional Blood Glucose Test Strips GS720 are for use with the Rightest Professional Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood samples.
The Rightest Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM720 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM720 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 Rightest Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Test Strips GS720 are for use with the Rightest Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Rightest Blood Glucose Monitoring System GM720 consists of the following devices: Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strip GS720, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strips GS720, and Lancing Device are manufactured by BIONIME Corporation.
The Rightest Professional Blood Glucose Monitoring System GM720 consists of the following devices: Rightest Professional Blood Glucose Meter GM720, Rightest Professional Blood Glucose Test Strip GS720, and Rightest Control Solution GC700. This system should only be used with auto-disabling, single-use lancing devices and sterile lancets. The Rightest Professional Blood Glucose Meter GM720 and Rightest Professional Blood Glucose Test Strips GS720 are manufactured by BIONIME Corporation.
Biomine's Rightest™ GM720 system is an electronic device that utilizes the electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood is placed on a disposable test strip coated with FAD-glucose Dehydrogenase (FAD-GDH). Within five seconds, the level of blood glucose will be shown on the digital display screen.
Rightest™ Blood Glucose Monitoring System GM720, with an auto-coding feature, requires only minimum of 0.75 microliter of blood for the testing, therefore it reduces the time and effort required for testing and improves the compliance of diabetic people to their testing regimens.
Device Name: Bionime Rightest™ Blood Glucose Monitoring System GM720, Bionime Rightest™ Professional Blood Glucose Monitoring System GM720
This response describes the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state the numerical acceptance criteria for the system accuracy study in a clear, tabulated format. However, it states that "The accuracy study... demonstrates that the accuracy of Rightest Blood Glucose Monitoring System GM720 met the acceptance criteria." This implies that predefined criteria were used and successfully met.
Based on the general context of blood glucose monitoring systems, acceptance criteria typically align with standards like ISO 15197 for accuracy. Common criteria are usually expressed as a percentage of measurements falling within a certain deviation from a reference method, particularly at different glucose concentration ranges. Without the specific numerical thresholds, it's impossible to create a precise table.
However, the reported performance is implicitly that the device did meet these unstated acceptance criteria.
Note: The document only states that the device "met the acceptance criteria" without providing the specific numerical targets for accuracy (e.g., % within ±15 mg/dL or ±15%). For a comprehensive answer, these numerical criteria would be needed.
2. Sample Sizes Used for the Test Set and Data Provenance
-
System Accuracy Study (Test Set):
- Sample Size: 121 patients were recruited.
- Data Provenance: Not specified in the provided text (e.g., country of origin). The study involved "whole blood (plasma equivalent) glucose values" and "plasma glucose values on a lab instrument," suggesting a clinical setting.
- Retrospective/Prospective: Not explicitly stated, though the recruitment of "patients" for a study generally implies a prospective collection of data for the purpose of the study.
-
User Performance Study (Test Set):
- Sample Size: 165 laypersons.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective/Prospective: Not explicitly stated, but recruiting "laypersons" to demonstrate they "could obtain accurate results using the subject device" strongly suggests a prospective study design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document mentions "plasma glucose values on a lab instrument" as the comparator for the System Accuracy Study.
- Number of Experts: Not explicitly stated. The ground truth would typically be established by laboratory technicians or medical professionals operating the reference laboratory instrument.
- Qualifications of Experts: Not explicitly stated. However, personnel operating a "lab instrument" for plasma glucose measurements are expected to be trained and qualified in clinical laboratory procedures.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for either the System Accuracy Study or the User Performance Study. The System Accuracy Study directly compared the device's readings to a lab instrument's plasma glucose values, implying a direct comparison rather than an adjudication process involving multiple interpretations of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not conducted or reported in the provided text. This device is a blood glucose monitoring system, which directly measures glucose levels and does not involve human interpretation or AI assistance in the reading of results in the way a medical imaging AI would.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The "System Accuracy Study" evaluated the "Rightest Blood Glucose Monitoring System GM720" by comparing its glucose values directly with a reference lab instrument. This represents the standalone performance of the device itself, without human intervention in the result generation or interpretation beyond the standard operation of the device.
7. Type of Ground Truth Used
- For System Accuracy Study: The ground truth was established using plasma glucose values on a lab instrument. This is a highly accurate and standardized method typically used as a reference in clinical laboratories for glucose measurement.
- For User Performance Study: The ground truth was implicitly the same (laboratory reference method), as the study aimed to demonstrate that lay users could obtain "accurate results" comparable to the performance already established by the system accuracy study.
8. Sample Size for the Training Set
The provided document does not mention a training set. This is typical for a medical device like a blood glucose meter, which relies on electrochemical measurement principles rather than machine learning algorithms that require extensive training data. The device's performance is based on its hardware and firmware design, not a learning algorithm developed using a "training set."
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable for this type of device, this question is not relevant.
§ 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.