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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 GDH Professional LED 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 venous whole blood. The GDH Professional LED 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 GDH Professional LED Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GDH Professional test strips are for use with the GDH Professional LED meter to quantitatively measure glucose (sugar) 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 GDH Professional control solutions are for use with the GDH Professional LED meter and GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GDH 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 venous whole blood. The GDH 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 GDH Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes and/or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GDH Professional test strips are for use with the GDH Professional meter to quantitatively measure glucose (sugar) 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 GDH Professional control solutions are for use with the GDH Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GDH Professional Blood Glucose Monitoring System and GDH Professional LED 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 in vitro diagnostic devices 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.

This 510(k) summary does not contain the detailed acceptance criteria or study results needed to complete the requested table and answer all questions directly. It provides a high-level statement that "The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not specify the numerical criteria, the reported device performance against those criteria, or the details of the studies conducted.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that "The device passed all of the tests based on pre-determined Pass/Fail criteria," but does not list these criteria or the specific performance metrics achieved. For a blood glucose monitoring system, typical acceptance criteria would be based on ISO 15197 (e.g., percentage of results within ±15% or ±20% of a reference method).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document mentions "Verification, validation and testing activities" but does not specify the sample size for any of these tests or the origin/type of data (retrospective/prospective, country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable/provided in the context of a blood glucose monitoring system's analytical performance testing. Ground truth for blood glucose measurements is typically established by laboratory reference methods (e.g., YSI instrument), not by expert consensus or interpretation of images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads), not for objective measurements by a device like a blood glucose meter.

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 information is not applicable/provided. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to diagnostic imaging and AI applications, not to the performance assessment of a blood glucose monitoring system.

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

The device itself is a standalone system for measuring glucose. There is no "human-in-the-loop" component in terms of interpretive performance that would require this type of study. The study implies an evaluation of the device's accuracy against a reference method, which is inherently standalone performance. However, the details of this standalone performance are not provided.

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

This information is not explicitly stated but can be inferred. For a blood glucose monitoring system, the "ground truth" or reference method is typically a laboratory-grade analyzer (e.g., YSI). The document mentions "analytical performance," which strongly implies comparison to a highly accurate reference method.

8. The sample size for the training set:

This information is not applicable/provided. Blood glucose monitoring systems, as described, do not typically involve "training sets" in the machine learning sense. Their calibration and performance are based on chemical and electrochemical principles, and physical calibration processes, rather than on algorithm training with large datasets.

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

This information is not applicable/provided for the reasons stated above.

Summary of available information:

• Device Name: GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
• Indication for Use: Quantitative measurement of glucose in capillary and venous whole blood for multiple-patient use in professional healthcare settings, as an aid to monitor the effectiveness of a diabetes control program. Not for diagnosis, screening, or neonatal use.
• Study Type: The document states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This implies analytical accuracy, precision, and robustness testing. Additionally, a Disinfection Study and a Robustness Study were performed.
• Predicate Device: GluNEOTM Lite Professional Blood Glucose Monitoring System (K132966) by Infopia Co., Ltd.
• Conclusion: The device is substantially equivalent to the predicated device based on verification/validation activities.

Missing Key Information for a Comprehensive Answer:

To fully answer your request, detailed study reports providing the following would be needed:

• Specific analytical accuracy and precision criteria (e.g., according to ISO 15197)
• The actual performance results of the device against those criteria (percentage within specific error limits).
• The exact sample sizes (number of subjects, number of samples per subject) used in performance studies.
• The specific reference method used for ground truth (e.g., YSI 2300 STAT Plus Glucose & L-Lactate Analyzer).
• Details of the collected data (e.g., glucose range covered, patient demographics).

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