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The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart 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 BLE Smart Blood Glucose Test Strips are for use with the BLE Smart 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 BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly.

The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System 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 BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.

BLE Smart Blood Glucose Monitoring System / BLE Smart Professional Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BLE Smart Blood Glucose Monitoring System, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary (K160365) does not explicitly list quantitative acceptance criteria in a table format. However, it states that:

• "The device passed all of the tests based on pre-determined Pass/Fail criteria."
• "The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated [sic] device."

This implies that some performance metrics, likely related to glucose measurement accuracy, precision, and safety, were evaluated and met the pre-defined criteria. The predicate device (K130181, GluNEO™ Blood Glucose Monitoring System) would have had its own set of performance criteria, and the new device is deemed substantially equivalent.

For a blood glucose monitoring system, common performance metrics and their typical acceptance criteria (based on ISO 15197 or similar standards) would include:

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

The provided text does not specify the sample size used for the performance testing (often referred to as verification/validation activities). It broadly states that "Verification, validation and testing activities were conducted."

The data provenance is not explicitly mentioned but typically for medical device submissions, it would be prospective data collected specifically for the regulatory submission. The applicant, Infopia Co., Ltd., is based in the Republic of Korea. Therefore, the data would likely originate from studies conducted in the Republic of Korea or other regions where they have conducted clinical testing. The text does not indicate whether the data was retrospective or prospective, but for performance validation, it would strongly be implied to be prospective.

3. Number of Experts Used to Establish the 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 for establishing ground truth. For blood glucose monitoring systems, ground truth (reference values) is typically established using a highly accurate laboratory reference method (e.g., hexokinase method on a central laboratory analyzer) rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. For blood glucose measurements, adjudication methods as typically understood in image analysis (e.g., 2+1, 3+1) are not generally applicable. Instead, the focus is on the agreement between the device's reading and the laboratory reference method. Discrepancies would be investigated, but not "adjudicated" in the same sense as expert reviews.

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 done. MRMC studies are typically used for diagnostic imaging devices where human interpretation is a critical component. For a blood glucose meter, the measurement is largely automated, reducing the role of human "readers" in the primary measurement task. Therefore, the concept of improving human readers with AI assistance does not directly apply here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance testing for the blood glucose monitoring system is inherently standalone. The device (meter and test strips) measures glucose concentrations directly. The listed "Verification, validation and testing activities" would refer to the performance of the algorithm and hardware without human intervention, compared against a laboratory reference.

7. The Type of Ground Truth Used

While not explicitly stated, for blood glucose monitoring systems, the ground truth is established using a laboratory reference method (e.g., a YSI analyzer or similar highly accurate enzymatic assay, typically the hexokinase method). This is considered the gold standard for glucose measurement in blood samples.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its size. For a glucose meter, the device is designed based on electrochemical principles and calibration protocols. While there is development and optimization, it's not typically described in terms of a "training set" like a machine learning algorithm. The "verification, validation and testing activities" refer to the final performance evaluation rather than a training phase.

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

As noted above, the concept of a "training set" and associated ground truth establishment, as typically understood in AI/ML, is not directly applicable or described for this type of medical device in the provided text. The calibration and development would be based on established chemical and electrical engineering principles, with reference to highly accurate laboratory methods for accuracy and linearity.

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