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The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured using capillary whole blood from the fingertip by using Rightest Blood Glucose Monitoring System.

This test device is not intended for testing neonate blood samples.

Special condition for use statement(s): Rightest System provides plasma equivalent results.

Our Blood Glucose Monitoring System includes Meter, Blood Glucose Test Strips, Code Kev. Check key, One Control Solution, Lancing Device and lancets. Rightest meter, Blood Glucose Test Strips, Code Key and Check key are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood.

The performance of the Rightest Blood Glucose Test Strips is verified by Control Solution. The Check key verifies the status of Rightest meter.

Here's a breakdown of the acceptance criteria and the study details for the Rightest Blood Glucose Monitoring System, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated section with pass/fail values. However, the reported performance metrics from the clinical studies serve as the basis for demonstrating equivalence and suitability for its intended use. The implicit acceptance criterion appears to be strong correlation and agreement with a reference method/technician.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Consumer Study (Field Test):
     • Sample Size: 128 patients.
     • Data Provenance: Not explicitly stated, but clinical testing typically originates from the location of the submitting company or its contractors. Given the submitter's identification as BIONIME CORPORATION in Taiwan, it's highly probable the data is from Taiwan. The study is prospective in nature, as it involves active testing with the device.
   • Point of Care Study:
     • Sample Size: 309 blood samples.
     • Data Provenance: Not explicitly stated regarding country, but performed in "the same general hospital," implying a prospective study. Again, likely from Taiwan.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Consumer Study: Ground truth was established by "technician" measurements. The specific number of technicians and their qualifications (e.g., years of experience, specific certifications) are not specified in the summary.
   • Point of Care Study: The ground truth was established by the YSI 2300D glucose analyzer. This is an automated reference instrument, not human experts, so the concept of "number of experts" is not applicable here.

3. Adjudication method for the test set:

   • Not applicable or Not specified. The studies compare the device's measurements directly to a reference (technician or YSI 2300D), rather than having multiple human readers interpret results that then require adjudication.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a blood glucose monitoring system, and the studies focused on the accuracy of the device's quantitative measurements compared to reference methods, not on human interpretation or decision-making aided by AI.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the clinical studies presented, particularly the "Point of Care Study" comparing the Rightest Blood Glucose Monitoring System directly to the YSI 2300D glucose analyzer, demonstrate the standalone performance of the device (i.e., the algorithm/system's ability to measure glucose). While a "consumer study" also involved lay users, the comparison was to "technician" measurements, still fundamentally assessing the device's standalone accuracy when used by different operators.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Consumer Study: "Technician" measurements (implied to be highly accurate laboratory or clinical measurements). This leans towards expert-performed reference measurements.
   • Point of Care Study: YSI 2300D glucose analyzer measurements. This is considered a gold standard reference instrument for glucose measurement.

7. The sample size for the training set:

   • Not specified. The summary only provides details on the clinical validation/test sets, not on any internal training sets used during the development of the device's algorithms or calibration. For blood glucose meters, "training" often refers to development of calibration curves and algorithms using a large number of samples, but these details are not typically included in 510(k) summaries for such devices unless it's a novel machine learning algorithm requiring specific training data disclosure.

8. How the ground truth for the training set was established:

   • Not specified. As the training set size and details are not provided, neither is how its ground truth was established.

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