(172 days)
The Rightest Blood Glucose Monitoring System, Model GM650 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by a single user at home to measure the glucose concentration as an aid to monitor the effectiveness of diabetes control. The glucose concentration is measured with quantitative capillary whole blood (from the fingertip, palm, and forearm), by using Rightest Blood Glucose Monitoring System, GM650.
This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus. And this device should not be used for testing multiple patients. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Rightest Blood Glucose Test Strips GS650 are intended for use with the Rightest Blood Glucose meter GM650 in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm.
Rightest Control Solutions GC650 are intended for use with the Rightest Blood Glucose Monitoring System. Model GM650 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended for single patient use only.
The Rightest Blood Glucose Monitoring System GM650 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 GM650 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 Strip GS650 is for use with the Rightest Blood Glucose meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The Rightest Control Solution Set GC650 is for use with the Rightest Blood Glucose meter GM650 and Rightest Blood Glucose Test Strips GS650 to check that the meters and test strip are working together properly and that the test is performing correctly.
The GE talking blood glucose monitoring system Model GE300 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The GE talking blood glucose monitoring system Model GE300 is intended for single patient use only.
The GE talking blood glucose monitoring system Model GE300 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 GE talking blood glucose monitoring system Model GE300 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 GE300 Blood Glucose Test Strip is for use with the GE talking blood glucose monitoring system Model GE300 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The GE300 Control Solution Set is for use with the GE talking blood glucose monitoring system Model GE300 and GE300 Blood Glucose Test Strips to check that the meters and test strip are working together properly and that the test is performing correctly.
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Three Control Solutions, Lancing Device and Lancets.
The Rightest Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.
Bionime's Rightest™ GM650 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) which interacts with the software driven digital talking meter. Within five seconds, the level of blood glucose will be shown on the digital display screen.
Rightest™ Blood Glucose Monitoring System, with an auto-coding feature, requires only minimum of I 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.
Here's an analysis of the acceptance criteria and study details for the Bionime Rightest Blood Glucose Monitoring System, Model GM650, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states that the Rightest Blood Glucose Monitoring System Model GM650 "met the acceptance criteria" for its accuracy study. However, it does not explicitly list the quantitative acceptance criteria for blood glucose monitoring systems (e.g., specific percentages within certain glucose ranges). Without those specific criteria, a table comparing them to reported performance cannot be fully constructed.
What is present:
| Performance Metric | Reported Device Performance | Acceptance Criteria |
|---|---|---|
| System Accuracy | "met the acceptance criteria" | Not explicitly stated in the document. (Typically involves standards like ISO 15197 or FDA guidance for glucose meters, e.g., ±15% or ±15 mg/dL for specified percentages of readings). |
| User Performance | "shows substantial equivalence to Rightest Blood Glucose Monitoring System used in finger, palm and forearm position" | Not explicitly stated in the document. (Implies achieving similar accuracy levels as the predicate device when used by lay users from multiple sites). |
Study Details:
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Sample sizes used for the test set and data provenance:
- System Accuracy Study: 118 patients. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it's implied to be a prospective clinical study involving patient samples.
- User Performance Study: 161 consumers. The provenance is not specified, but it's implied to be a prospective study involving lay users.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The ground truth for the System Accuracy Study was established by "plasma glucose values on a lab instrument." This implies a reference laboratory method and instrument, not human experts. The qualifications of the operators of the lab instrument are not specified.
- For the User Performance Study, the ground truth would also be the "lab instrument" readings, as the study aims to show that lay users can obtain accurate results compared to a reference method, not necessarily compared to expert interpretation of the device's output.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method involving multiple experts is described for either the System Accuracy Study or the User Performance Study. The ground truth relies on a single laboratory reference instrument.
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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 MRMC comparative effectiveness study was done or is described in the summary. This type of study is not relevant for a blood glucose monitoring system, which provides a direct quantitative reading rather than images or data requiring interpretation by human readers, or AI-assisted interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "System Accuracy Study" can be considered a standalone performance evaluation of the device (meter + strip) which incorporates the algorithm to generate a glucose reading. It compares the device's output directly to a reference method, without human interpretation of the device's reading as part of the primary outcome. The "User Performance Study" assesses the "human-in-the-loop" aspect by having lay users operate the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the System Accuracy Study, the ground truth was "plasma glucose values on a lab instrument." This is a laboratory-based reference method, considered highly accurate for glucose measurement.
- For the User Performance Study, the ground truth would implicitly be the same "plasma glucose values on a lab instrument," serving as the benchmark against which lay user results are compared.
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The sample size for the training set:
- The document does not explicitly mention a "training set" or its sample size. This type of device (blood glucose meter with a fixed algorithm) typically undergoes development and internal validation, but a distinct "training set" as understood in machine learning is not usually detailed in such regulatory summaries for these types of devices. The "verification and validation of test results" mentioned generally refers to the internal development and testing processes prior to clinical studies.
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How the ground truth for the training set was established:
- Since no training set is explicitly mentioned or detailed, the method for establishing its ground truth is also not provided. The development process would have involved rigorous testing against calibrated reference standards and established laboratory methods.
§ 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.