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The Rightest Blood Glucose Monitoring System GM280B is intended to 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 GM280B is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280B 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 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 GS280 is used with Rightest meter GM280B for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE Blood Glucose Monitoring System 182 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 GE Blood Glucose Monitoring System 182 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 182 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 Blood Glucose Monitoring System 182 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 GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 182 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 GM280 is intended to 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 GM280 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280 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 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 GS280 is used with Rightest meter GM280 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE Blood Glucose Monitoring System 180 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 GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 180 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 Blood Glucose Monitoring System 180 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 GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 180 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest and GE Blood Glucose Monitoring System series consists 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.

The Rightest Blood Glucose Meter GM280 and Rightest Blood Glucose Meter GM280B, when used with the Rightest Blood Glucose Test Strips GS280, quantitatively measure glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM280 and Rightest Blood Glucose Monitoring System GM280B are verified by the Rightest Control Solution GC550.

The GE Blood Glucose Meter 180 and GE Blood Glucose Meter 182, when used with the GE Blood Glucose Test Strips 180, quantitatively measure glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 are verified by the Rightest Control Solution GC550.

The provided text describes the acceptance criteria and the study conducted for the GE Blood Glucose Monitoring System series.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The main criterion for a glucose monitoring system's accuracy is typically measured against a laboratory reference method. For this device, the acceptance criteria relates to the accuracy of the blood glucose measurements compared to the YSI 2300 Plus Glucose Analyzer.

Acceptance Criteria and Reported Device Performance (System Accuracy Study)

Note: The exact numerical acceptance criteria for system accuracy (e.g., percentage of readings within a certain deviation from the reference) are not explicitly stated in the provided documents but are implied to have been met. For such devices, commonly, the ISO 15197 standard for blood glucose monitoring systems is referenced, which specifies accuracy requirements (e.g., 95% of results must be within ±15 mg/dL for glucose concentrations < 100 mg/dL and within ±15% for glucose concentrations ≥ 100 mg/dL).

2. Sample Sizes Used for the Test Set and Data Provenance

• System Accuracy Study:

  • Sample Size: A total of 104 patients participated.
  • Data Provenance: The document does not explicitly state the country of origin. It indicates the study used fresh capillary and venous whole blood samples. It is implied to be a prospective study, as patients "participated" in the study.

• User Performance Study:

  • Sample Size: A total of 135 subjects participated.
  • Data Provenance: The document does not explicitly state the country of origin. It mentions "English speaking and reading lay users." It is implied to be a prospective study, as "subjects participated."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• For the System Accuracy Study, the ground truth was established by a laboratory instrument, the YSI 2300 Plus Glucose Analyzer. This is a highly accurate and widely accepted reference method for glucose measurement. Therefore, human experts were not directly used to establish the ground truth for individual measurements, but the operation and calibration of such an analyzer would be performed by qualified laboratory personnel.

• For the User Performance Study, the ground truth was "user accuracy" and "ease of use" via a "participant questionnaire scoring." This implies the "ground truth" was derived from the users' ability to correctly use the device and their subjective feedback on ease of use. While this involves user self-assessment, the evaluation of the results would be done by qualified study personnel. The document does not specify the number or qualifications of experts involved in the design of the questionnaire or the assessment of its results.

4. Adjudication Method for the Test Set

• For the System Accuracy Study, since the ground truth was established by a single, highly accurate laboratory instrument (YSI 2300 Plus Glucose Analyzer), no multi-expert adjudication method (like 2+1 or 3+1) would be necessary for individual glucose measurements.

• For the User Performance Study, no adjudication method for establishing ground truth is mentioned, as it relies on participant questionnaire scoring for user accuracy and ease of use.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study, which typically applies to imaging diagnostics comparing human readers with and without AI assistance, was not conducted. This is a blood glucose monitoring system, not an imaging AI device. The studies described are for system accuracy and user performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• The "System Accuracy Study" can be considered a form of standalone performance evaluation for the device's measurement capability. It assesses the device's output against a reference standard, independent of user intervention (beyond sample collection), to quantify its inherent measurement accuracy. The "User Performance Study" then evaluates the device with human-in-the-loop (lay users), ensuring it performs accurately in user hands.

7. The Type of Ground Truth Used

• System Accuracy Study: The ground truth was established using a laboratory reference method (YSI 2300 Plus Glucose Analyzer), which provides highly accurate glucose concentration values.
• User Performance Study: The ground truth for "user accuracy" was likely determined by comparing the glucose readings obtained by lay users with the values from a reference method (though not explicitly stated whether the YSI was used for this part as well, it's standard practice). The "ease of use" ground truth was established via participant questionnaire scoring, which is a form of subjective user outcomes data.

8. The Sample Size for the Training Set

• The provided document describes verification and validation studies (test sets) for the blood glucose monitoring system. It does not mention a training set or any machine learning/AI model training. Blood glucose meters do not typically involve a "training set" in the sense of AI/ML algorithms that learn from data. Their performance is based on their electrochemical design and calibration.

9. How the Ground Truth for the Training Set was Established

• Since there is no mention of a "training set" or AI/ML model for this device, this question is not applicable based on the provided text. The device's functionality is based on established electrochemical principles, not on learned parameters from a data training set.

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