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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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The MyGlucoHealth Wireless System 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 glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand,upper arm, forearm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady-state times (when glucose is not changing rapidly).

The MyGlucoHealth Wireless System comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The MyGlucoHealth Wireless Meter is different from the MyGlucoHealth Blood Glucose Meter (MGH-BT1) only by the way the glucose data is transferred to the data repository. An embedded cellular module within the meter enables Wireless communication between the meter and the Entra Health Systems remote database called MyHealthPoint TeleHealth Manager (K132930).

The test strip (proprietary to the MyGlucoHealth Wireless Meter) is used only with the MyGlucoHealth Wireless Meter. It is for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. The MyGlucoHealth Wireless System is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.

Here's a breakdown of the acceptance criteria and the study information for the MyGlucoHealth Wireless System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document refers to the ISO 15197:2003 standard, which outlines requirements for blood glucose monitoring systems. While the specific numerical acceptance criteria from this standard are not explicitly listed in detail within the summary, the summary states that "All testing demonstrated the safety and effectiveness of the MyGlucoHealth Wireless Meter and substantial equivalence to the predicate."

A key aspect of performance for blood glucose monitoring systems is accuracy. Although a detailed table of performance against specific accuracy thresholds (e.g., within X% of a reference method) is not present in this summary, the substantial equivalence claim implies that its performance is comparable to the predicate device, which would have met such criteria.

Note: For a complete understanding of the device's accuracy against ISO 15197:2003, one would typically need to refer to the full test report or the specific performance data submitted with the 510(k) application, which is not fully included here. However, the mention of the standard indicates the type of criteria the device aims to meet.

Study Information

The document describes non-clinical testing and clinical testing.

2. Sample size used for the test set and the data provenance:

• Non-Clinical Testing:
  • Cleaning Validation Test (Robustness): 3 different meters were tested.
  • Cleaning Validation Test (Efficacy): The sample size for materials tested for disinfection efficacy is not specified, but it was performed by an outside testing laboratory.
• Clinical Testing (Human Factor testing): The sample size is not specified in the provided summary.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the clinical (human factors) study, or the non-clinical testing. However, given it's for FDA submission, it's generally expected to be prospective for human factors and laboratory-controlled for non-clinical.

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

• This information is not provided in the summary. For a blood glucose meter, the "ground truth" for accuracy assessments is typically established by comparative measurements against a well-established laboratory reference method (e.g., YSI analyzer), rather than expert consensus on individual readings.
• For the human factors testing, the definition of ground truth (e.g., successful task completion) would be based on predefined criteria, not expert assessment of individual readings.

4. Adjudication method for the test set:

• Not applicable in the context of this summary. Blood glucose meter performance is determined by quantitative comparison to reference methods, not subjective interpretation requiring adjudication among experts. For human factors, task completion or error rates would be measured against predefined success/failure criteria.

5. 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:

• This is not applicable to a blood glucose monitoring system like the MyGlucoHealth Wireless System. MRMC studies are typically used for imaging diagnostics where human readers interpret medical images, often with AI assistance. This device is a standalone in vitro diagnostic (IVD) device for quantitative measurement.

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

• Yes, the core performance evaluation of the MyGlucoHealth Wireless System is a standalone evaluation. The device itself measures glucose concentration and displays a numerical result. The "algorithm" here refers to the electrochemical principles and calibration within the test strip and meter to convert a biochemical reaction into a glucose reading. The system's accuracy is assessed directly against a reference method.

7. The type of ground truth used:

• For glucose measurement accuracy: Typically, a laboratory reference method (e.g., YSI glucose analyzer) is used as the ground truth. This is implied by the adherence to ISO 15197:2003, which requires comparison to a traceable reference measurement procedure.
• For cleaning/disinfection efficacy: Specific laboratory standards for viral inactivation are used.
• For human factors: Predefined criteria for task completion and user comprehension are typically used to establish ground truth.

8. The sample size for the training set:

• This information is not explicitly provided. For a traditional electrochemical blood glucose meter, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed through engineering and chemistry principles, using a variety of samples during development and manufacturing to establish its operating characteristics.

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

• Not applicable in the machine learning context. For this type of device, ground truth for calibration and development would be established through precise laboratory measurements using reference methods and well-characterized samples over a range of glucose concentrations, hematocrit levels, and interfering substances.

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