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The Element™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Element™ Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element™ Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Element™ Lite Test Strips are for use with the Element™ Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The Element™ Lite Control Solutions are for use with the Element™ Lite Meter and Element™ Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The Element™ Lite Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 1, level 2 and level 3), a lancing device and sterile lancets. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

The Element™ Lite Blood Glucose Monitoring System underwent performance testing in accordance with ISO 15197:2003 and other international standards.

Here's a breakdown of the acceptance criteria and study details, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes that "The device passed all of the tests based on predetermined Pass/Fail criteria." However, it does not explicitly list the specific acceptance criteria or the numerical performance results for the glucose measurements. It only states that clinical evaluation included method comparison, user performance, and alternative-site blood glucose measurement.

Therefore, the table can only reflect what is mentioned:

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

The document does not specify the sample size used for the test set. It mentions "Clinical evaluation included method comparison, user performance and alternative-site blood glucose measurement," but provides no details on the number of participants or samples.

Regarding data provenance, the study was conducted by Infopia Co., Ltd., which is based in the Republic of Korea. Therefore, the data likely originated from Republic of Korea. The study implicitly appears to be prospective as it involves clinical evaluation of the device's performance.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. For blood glucose meters, the "ground truth" is typically established by laboratory reference methods (e.g., YSI glucose analyzer), not expert consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set. Given the nature of blood glucose measurement, adjudication by multiple experts is not typically applicable in the same way as it might be for diagnostic image interpretation. The comparison would be against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This type of study is more relevant for AI algorithms that assist human readers in tasks like interpreting medical images. The Element™ Lite Blood Glucose Monitoring System is a standalone diagnostic device for direct measurement by patients.

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

Yes, a standalone performance evaluation was conducted. The "Element™ Lite Blood Glucose Monitoring System" itself is a standalone device. The performance data discussed (method comparison, user performance, alternative-site measurement) are assessments of the device's ability to accurately measure glucose independently. There is no indication of a human-in-the-loop component for the measurement process itself.

7. The Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth for performance evaluation is typically established using a laboratory reference method (e.g., a glucose analyzer like a YSI STAT PLUS Glucose & Lactate Analyzer or equivalent). This is implied by "method comparison" studies. It is not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. As this is a direct measurement device rather than an AI/machine learning algorithm that requires extensive training data, a traditional "training set" in that sense might not exist or be explicitly identified in the same way. The device's performance is based on its chemical and electrical design, calibrated and validated against reference standards.

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

Since the document does not mention a specific "training set" for an algorithm, it also does not provide information on how ground truth for such a set would have been established. Any internal calibration or design validation would involve comparing the device's readings against established reference standards.

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