(89 days)
The Rightest Blood Glucose Monitoring System GM700S consists of the Rightest Blood Glucose Monitoring Meter GM700S and the Rightest Blood Glucose Test Strips GS700. The Rightest Blood Glucose Monitoring System GM700S 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 GM700S is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The systems 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 Monitoring System GM700SB consists of the Rightest Blood Glucose Monitoring Meter GM700SB and the Rightest Blood Glucose Test Strips GS700. The Rightest Blood Glucose Monitoring System GM700SB 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 GM700SB is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The systems 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).
Rightest Blood Glucose Monitoring System GM700S and Rightest Blood Glucose Monitoring System GM700SB, consist of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing device and Sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. Rightest Meter GM700S and Rightest Meter GM700SB (with Bluetooth), when used with the Rightest Test Strips GM700S, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of Rightest Blood Glucose Monitoring System GM700S and Rightest Blood Glucose Monitoring System GM700SB (with Bluetooth) are verified by the Rightest Control Solution GC700.
Here's a breakdown of the acceptance criteria and study information for the Rightest Blood Glucose Monitoring System GM700S and GM700SB, based on the provided document:
Acceptance Criteria and Device Performance
The document summarizes the performance tests conducted, but does not explicitly state "acceptance criteria" in a separate section. Based on the provided performance characteristics and the conclusion of "substantial equivalence," the implicit acceptance criteria would be that the device performs comparably to the predicate device and meets established standards for blood glucose monitoring systems.
Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Feature/Performance Metric | Implicit Acceptance Criteria (based on predicate/standards) | Reported Device Performance (GM700S/GM700SB) |
|---|---|---|
| Minimum Sample Volume | Comparable to predicate (0.75 microliter) | 0.75 microliter |
| Test Time | Comparable to predicate (5 seconds) | 5 seconds |
| Hematocrit Range | Comparable to predicate (20-65%) | 20 - 60 % |
| Memory Capacity | Sufficient for user needs (500 results) | 500 blood glucose test results with date and time |
| Power Saving | Functional and user-friendly | Turns off automatically 2 minutes after last user action / Press main button for 3 seconds |
| Coding | Accurate and user-friendly (Auto coding) | Auto coding |
| Measurement Technology | Standard and accurate (Dehydrogenase Electrochemical Sensor) | Dehydrogenase Electrochemical Sensor |
| Sample Type | Specified (Fresh capillary whole blood) | Fresh capillary whole blood from fingertips, palm, or forearm. |
| Measuring Range | Clinically relevant (20-600 mg/dL) | 20 - 600 mg/dL |
| Operating Temperature | Suitable for intended use (10 ~ 40°C) | 10 ~ 40°C (50 ~104 °F) |
| Operating Relative Humidity | Suitable for intended use (10-90%) | 10~90% |
| Monitor | Clear display (LCD) | LCD display |
| Meter Storage Conditions | Specified (-10 ~ 60°C) | -10 ~ 60°C (14~140 °F) |
| Test Strip Storage Conditions | Specified (4 ~ 30℃) | 4 ~ 30℃ (39~ 86 °F), 10 - 90% relative humidity |
| Unit of Measurement Data | Fixed (mg/dL) | Fixed on mg/dL |
| Backlight | (Predicate has Yes, Device has No, but not a critical difference for substantial equivalence) | No |
| Strip Shelf Life - Open Vial | (4 months) | 4 months |
| Control Solution | Specified (Rightest Control Solution GC700) | Rightest Control Solution GC700 |
| Interference | Acceptable levels (specified compounds and concentrations) | Ascorbic acid ≥ 3 mg/dL, Uric acid ≥ 10 mg/dL, Xylose ≥ 20 mg/dL |
| Reagent Composition | Specified and comparable | FAD-Glucose dehydrogenase 12.4%, Potassium Ferricyanide 49.6%, Non-reactive Ingredients 38.0% (GM700S) |
| FAD-Glucose dehydrogenase 12.1%, Potassium ferricyanide 48.5%, Non-reactive ingredients 39.4% (GM700SB) | ||
| Wireless module | (GM700S: No, GM700SB: Yes) | GM700S: No, GM700SB: No (contradicts table which suggests GM700SB has Bluetooth – this part of the table is inconsistent; it likely implies GM700SB does have a wireless module) |
| Power Supply | Specified (CR2032 batteries) | One CR2032 battery (GM700S), Two CR2032 batteries (GM700SB) |
| Battery Life | Sufficient (1000/600 tests) | 1000 tests (GM700S), About 600 tests (GM700SB) |
| User Performance | Lay users obtain accurate results | Study shows substantial equivalence |
Study Details
The document describes one clinical study: a User Performance Study.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A total of 354 patients participated.
- Data Provenance: The document does not explicitly state the country of origin. It also does not specify if the study was retrospective or prospective, but "user performance study" typically implies a prospective collection of data from real users.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the user performance study. In blood glucose monitoring studies, ground truth is usually established by a laboratory reference method, not by expert consensus on the device's readings. The study's aim was to show that lay users could obtain accurate results, meaning the comparison would be against a known accurate measurement.
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Adjudication Method for the Test Set:
- The document does not describe an adjudication method. For performance studies of blood glucose meters, the standard is typically comparison to a laboratory reference method, not an adjudication process among experts looking at the device results.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, performance evaluations for the device itself (what could be considered the "algorithm only" in a different context) were conducted. The document mentions "precision, linearity, interference, sample volume, hematocrit, and operated environment" evaluations, which are standalone tests of the device's technical performance characteristics. The user performance study then assessed the human-in-the-loop aspect.
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The type of ground truth used:
- For the user performance study, the ground truth would have been established by a laboratory reference method for blood glucose measurement (e.g., a YSI analyzer), to which the device's readings are compared. The document doesn't explicitly name the reference method, but this is the standard for such studies.
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The sample size for the training set:
- The document does not mention a training set sample size. Blood glucose meters do not typically involve "training sets" in the same way machine learning models do. Their calibration is usually established during manufacturing based on known glucose concentrations.
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How the ground truth for the training set was established:
- N/A, as there is no explicitly mentioned "training set" for an algorithm in the machine learning sense. The device's calibration and performance parameters are established through rigorous engineering and testing processes using samples with known glucose concentrations, typically traced to a reference method, during development and manufacturing.
§ 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.