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SD LipidoCare BT Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare BT Home Blood Glucose Test Strips are for use with SD LipidoCare BT Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare BT Home Lipid Profile Test Strips are intended for use with the SD LipidoCare BT Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare BT Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).

The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare BT Professional Blood Glucose Test Strips are for use with SD LipidoCare BT Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by lay users and medical professionals. SD LipidoCare BT Profile Test Strips are intended for use with the SD LipidoCare BT Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

SD LipidoCare Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare Home Blood Glucose Test Strips are for use with SD LipidoCare Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare Home Lipid Profile Test Strips are intended for use with the SD LipidoCare Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).

The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatments with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare Professional Blood Glucose Test Strips are for use with SD LipidoCare Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, or upper arm by lay users and medical professional Lipid Profile Test Strips are intended for use with the SD LipidoCare Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

SD LipidoCare (BT) Professional/Home Analyzer can measure TC, TG, HDL, and Glucose, and it also can calculate LDL and non-HDL using the blood sample from the human with the SD LipidoCare (BT) Profiessional/Home Lipid Profile and SD LipidoCare (BT) Professional/Home Glucose test strips. This system is portable using batteries for power source and can store up to 500 test results in the memory. Users can search the stored results and can review the average results for 7, 15 and 30 day glucose test results. The average calculation function is for glucose test results only. This system can set the beep, date, time, unit, auto printing, simplex/duplex printing, hypo warning for glucose, alarms and Bluetooth. The analyzer offers 2 models: one with Bluetooth function for printing the test results and transferring data to a PC via Bluetooth technology and the other without it. The analyzer without the Bluetooth unit can still print the test results and transfer the data to a PC using a cable.

The system includes Lipid Profile Test Strip which is based on a reflectance photometry, and Glucose Test Strip which is based on glucose oxidase biosensor.

There are also lipid check strips and glucose check the internal malfunction (or problem) of the analyzer prior to testing.

The code chip is for the analyzer to read the lot-specific characteristics of the test strips currently in use. The SD Ezi Tube+ is used to apply blood sample for lipid profile testing.

Here's a breakdown of the acceptance criteria and the study information for the SD LipidoCare systems, based on the provided document:

The document combines information for four devices: SD LipidoCare Home System, SD LipidoCare Professional System, SD LipidoCare BT Home System, and SD LipidoCare BT Professional System. All four systems are intended for the quantitative measurement of glucose, total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood. The "BT" versions add Bluetooth functionality.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with explicit acceptance criteria for each performance metric. Therefore, some information, particularly around specific acceptance criteria values and the detailed methodology of how "ground truth" was established, is inferred or generalized from the context of substantial equivalence testing for IVD devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the subject devices (SD LipidoCare systems). Instead, it relies on demonstrating substantial equivalence to predicate devices. However, it does list the test ranges for both the predicate and new devices, which can be seen as the operational range where performance is expected to be acceptable. Performance is generally presented as "substantially equivalent" rather than with specific quantifiable metrics against a pre-defined criterion table.

Inferred Performance and Comparison:

Acceptance Criteria Implication: For many IVD devices, acceptance criteria often relate to accuracy (bias, precision), linearity, interference, and user performance. The document states that "We performed various clinical and bench tests and the test results supported that despite these differences the [subject device is] substantially equivalent to the predicate devices." This implies that the performance of the new devices, within their specified (and sometimes wider) ranges, met the accepted performance characteristics typically associated with the predicate devices, thereby not raising questions of safety and effectiveness.

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

The document does not specify the sample size used for the "clinical and bench tests" that demonstrated substantial equivalence.

Data Provenance: The manufacturer is SD Biosensor, Inc. from the Republic of Korea. The document does not explicitly state whether the data was retrospective or prospective, but clinical and bench testing for 510(k) submissions are typically prospective studies designed to evaluate the new device's performance.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For in vitro diagnostic (IVD) devices measuring biomarkers, ground truth is typically established using established laboratory reference methods performed by qualified laboratory personnel, rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. For quantitative measurements by IVD devices, adjudication (like 2+1 or 3+1 for imaging studies) is generally not applicable in the same way. The comparison is usually made directly against a reference method.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where AI assists human readers. The SD LipidoCare systems are in vitro diagnostic devices for quantitative measurement of blood analytes.

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

The device itself is a standalone measurement system (analyzer and test strips). Its performance is inherently "standalone" in the sense that it provides a quantitative result without direct human interpretation of complex visual data or complex human-AI interaction. The "clinical and bench tests" would have evaluated this standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For IVD devices measuring analytes like glucose, total cholesterol, triglycerides, and HDL cholesterol, the ground truth is typically established using reference laboratory methods (e.g., enzymatic colorimetric methods on a chemistry analyzer) operated by trained laboratory professionals. These methods are considered the gold standard for accurate quantitative measurements for these specific analytes in blood. The document implies this approach through its discussion of "Substantial Equivalence," which generally means the device's results correlate sufficiently with established laboratory methods.

8. The Sample Size for the Training Set

The document does not specify the sample size for a "training set." These devices typically do not involve AI algorithms that require explicit "training sets" in the conventional machine learning sense. Their performance is based on the chemical and enzymatic reactions within the test strips and the photometric/biosensor reading technology, which are validated through analytical and clinical studies.

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

As noted above, a "training set" in the machine learning sense is not applicable here. The device's underlying principles (e.g., enzymatic reactions for glucose, photometric reading for lipids) are based on established scientific methods. Any calibration or internal adjustments made during manufacturing (which would be analogous to "training" in a very broad sense) would be done against reference standards, with the "ground truth" being the known concentrations of those reference standards.

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SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 diabetes control.

The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

SD GlucoNavii® Mentor BT Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor BT Multi 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 SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor BT Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

SD GlucoNavii® Mentor BT Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoNavii® Mentor BT and BT Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is indicated for singlepatient use at home (over-the-counter; OTC) and should not be shared, while the SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-thecounter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control.

A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.

The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The system can also set the pre-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

A Bluetooth unit for data transfer has been added to the subject devices in addition to NFC and USB cable communication features.

The following modifications were made on the subject device from the predicate device (K132929).

• 1. The addition of Bluetooth for wireless transmission of data to mobile device or PC, and which comprises the following modifications:
  • i. Changed printed circuit board (PCB) layout.
  • ii. Added Bluetooth module to PCB.
  • iii. Added and deleted electronic components to support the Bluetooth Module.
  • iv. Deleted USB communication circuit.
  • Changed Firmware. V.
  • Added Bluetooth icon to display. vi.
  • Extended automatic meter shutoff times to allow enough time for data transfer via Bluetooth. vii.
• 2. Memory capacity for stored glucose test results decreased from 300 to 100 records.
• 3. The trade name of the systems has changed from SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System and SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System to SD GlucoNavii® Mentor BT Blood Glucose Monitoring System and SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System.
• 4. The trade name of the test strips has changed from SD GlucoNavii® Mentor NFC Blood Glucose Test Strips and SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips to SD GlucoNavii® Mentor BT Blood Glucose Test Strips and SD GlucoNavii® Mentor BT Multi Blood Glucose Test Strips.
• 5. Labeling was modified to reflect the changes to the device.

This document is a 510(k) Premarket Notification from the FDA regarding the SD GlucoNavii® Mentor BT Blood Glucose Monitoring System and SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.

Therefore, much of the requested information, particularly regarding detailed study design, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not provided in this document as it pertains to clinical performance which the FDA states is "not applicable."

However, based on the provided text, we can extract the acceptance criteria (implicitly defined by the device's specifications and comparison to the predicate) and the reported device performance for certain aspects, primarily through the "Similarities and Differences" table.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or statistical format, but rather details the device's specifications, which act as de facto criteria. The reported device performance is largely presented by stating that the modified device's performance characteristics are "identical" to the predicate or within acceptable changes.

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

The document explicitly states: "Clinical sensitivity and clinical specificity testing are not applicable." This implies that no clinical performance study involving a patient test set was conducted for this 510(k) submission, as the focus was on demonstrating substantial equivalence based on non-clinical tests (design control, risk analysis, verification & validation activities) due to the nature of the modifications (primarily adding Bluetooth connectivity). Therefore, sample size for a clinical test set and its provenance are not provided.

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)

Not applicable, as no clinical test set was used for this submission.

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

Not applicable, as no clinical test set was used for this submission.

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

Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers and MRMC studies.

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

This is a standalone blood glucose meter. Its performance is evaluated intrinsically, and the "study" demonstrating its performance relies on the device itself against a reference method (not detailed here, but expected for glucose meters). The document indicates "design control, risk analysis and verification & validation activities" were performed, which would include testing the device's accuracy and precision, but the specific details of these tests (e.g., sample size, reference method) are not included in this summary.

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

For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory-grade reference method for glucose measurement (e.g., YSI glucose analyzer), which is considered the gold standard. However, the document does not explicitly state the specific reference method used for the verification and validation activities.

8. The sample size for the training set

Not applicable in the context of an AI/algorithm training set. For a traditional medical device like a glucose meter, "training" might refer to calibration data, but the document does not provide details on the sample size for such data.

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

Not applicable in the context of an AI/algorithm training set. For a glucose meter, the ground truth for calibration (if considered "training") would be established by measuring known glucose concentrations against a reference method.

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SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 diabetes control.

The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

SD GlucoNFC Blood Glucose Test Strips are for use with SD Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm.

SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.

SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm and venous whole blood. The SD GlucoNFC Multi 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 SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm and venous whole blood.

SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Multi Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.

SD GlucoNFC Blood Glucose Monitoring System and GlucoNFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while the SD GlucoNFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting (prescription; POC), in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology.

SD GlucoNFC Blood Glucose Monitoring System includes:

• SD GlucoNFC Blood Glucose Meter
• SD GlucoNFC Blood Glucose Test Strips
• SD Glucose Check Strip
• SD GlucoNavii® Control Solution – Level 2
• Lancet
• Lancing device (with a white cap for fingertip testing and a clear cap for Alternative Site Testing)
• User Instruction Guide
• Test Strip Package Insert
• Control Solution Package Insert

SD GlucoNFC Multi Blood Glucose Monitoring System includes

• SD GlucoNFC Multi Blood Glucose Meter
• SD GlucoNFC Multi Blood Glucose Test Strips
• SD Glucose Check Strip
• SD GlucoNavii® Control Solution Level 2
• User Instruction Guide
• Test Strip Package Insert
• Control Solution Package Insert

A drop of blood sample works with Glucose dehydrogenase (GDH) and potassium ferrocyanide in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.

The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: non-meal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL units. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

The provided document is a 510(k) Summary for the SD GlucoNFC Blood Glucose Monitoring System and the SD GlucoNFC Multi Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and the non-clinical and clinical tests performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets for each performance metric, nor does it always provide specific numerical results for the device's performance against those criteria. Instead, it generally states that "All the test results met the pre-set criteria."

However, we can infer some criteria and general performance from the "Similarities and Differences" table (Page 7) and the list of conducted tests (Page 9).

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

The document explicitly states that "the non-clinical studies and clinical-studies provided in this submission demonstrated that the differences do not raise and effectiveness." The list of tests on page 9 includes "System Accuracy," "Precision," "Linearity," "Sample Volume," "Hematocrit," "Matrix comparison," and "Interference Substances," which typically involve clinical or non-clinical data.

• Sample Size: The document does not specify the sample size used for any of the clinical or non-clinical tests (e.g., system accuracy, precision, linearity).
• Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It generally refers to "non-clinical studies and clinical-studies."

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

The document is for a Blood Glucose Monitoring System, which measures a quantitative value (glucose concentration). For such devices, the "ground truth" (or reference method) is typically established using a highly accurate laboratory reference instrument, not by human expert consensus or radiologists.

• Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth, as typically applied to image-based diagnostic systems, does not directly apply here. The ground truth for glucose measurements would be derived from a laboratory reference method.

4. Adjudication Method for the Test Set

As explained above, for a quantitative measurement device like a blood glucose meter, the ground truth is established by a reference laboratory method rather than by human interpretation requiring adjudication.

• Thus, adjudication methods (e.g., 2+1, 3+1) are not relevant to the type of ground truth used for this device.

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

The SD GlucoNFC Blood Glucose Monitoring System is a device designed for direct measurement of blood glucose, not an AI-powered image analysis system that assists human readers in diagnosis.

• Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. There is no mention of AI assistance or human readers improving diagnostic accuracy with the device.

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

This device is a standalone glucose measurement system. The blood glucose meter provides a numerical result directly to the user or healthcare professional. There isn't an "algorithm only" component separate from the meter's function, as the meter itself performs the measurement.

• The performance metrics like "System Accuracy," "Precision," and "Linearity" inherently represent the standalone performance of the device (the meter and test strip system).

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established against a laboratory reference method that is highly accurate and precise, often a hexokinase or glucose oxidase method run on a clinical chemistry analyzer.

• The document implies this by stating "System Accuracy" and "Matrix comparison" tests were performed, which compare the device's readings to a known, precise reference. It does not explicitly name the reference method but it's understood in the context of these devices.
• It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document describes premarket notification (510(k)) to demonstrate substantial equivalence, focusing on testing the final device. It does not mention a "training set" in the context of machine learning or AI.

• This device is a traditional electrochemical biosensor, not an AI/ML-based system requiring a distinct training dataset.

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

As there is no mention of an AI/ML component or a "training set," this question does not apply to the information provided.

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The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.

The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.

The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.

The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh capillary or venous whole blood samples. It is intended for professional use.

The SD HbA1c Control Set is intended for use as quality control materials for the SD A1cCare System.

The SD A1cCare System include the analyzer, analyzer check strip, DC power adapter, immunoassay test panels, lot-specific calibration code chips, and control set.

Here's a breakdown of the acceptance criteria and study information for the SD A1cCare System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "All testing met acceptance criteria," but it does not provide a table with specific numerical acceptance criteria alongside the reported device performance for each test. Instead, it lists the types of tests conducted.

To provide a tabular format, I will extract the types of tests mentioned under "Functional and Safety Testing" and indicate that the results met unstated acceptance criteria.

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

The document mentions "a user study clinical evaluation was conducted comparing home user results against a reference method." However, it does not specify the sample size for this test set nor the specific country of origin for the data. It implies the data is prospective, gathered from the user study.

For other functional and safety tests, no specific sample sizes are provided.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth. It states "comparing home user results against a reference method," but the nature of this reference method and the involvement of experts in its establishment or application are not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. It only mentions a comparison against a "reference method."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is an immunoassay system designed for quantitative measurement, not an imaging or diagnostic aid typically assessed via MRMC studies. The "user study clinical evaluation" compared home user results to a reference method, which is different from an MRMC study assessing human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies described are indicative of standalone performance of the device. The "SD A1cCare System" is an automated reflectometry immunoassay system. The bench testing and clinical evaluation would assess the performance of this system (analyzer and test kit) in isolation, measuring its accuracy, precision, linearity, etc., without an explicit human-in-the-loop component influencing the measurement itself. The "user study clinical evaluation" did involve home users, but their role was in operating the device, not in interpreting results in conjunction with an AI algorithm.

7. Type of Ground Truth Used

The ground truth for the clinical evaluation was established by a "reference method". The specific nature of this reference method is not detailed, but for HbA1c assays, it typically refers to a highly accurate laboratory method (e.g., HPLC or mass spectrometry, often NGSP-certified) used to provide the true HbA1c values against which the device's measurements are compared.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. Immunoassays like the SD A1cCare System typically use a different development and validation paradigm than machine learning models that require distinct training and test sets. While the system may have undergone internal calibration and optimization during development, the text does not refer to a "training set" in the context of a machine learning algorithm.

9. How Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is mentioned, this information is not available in the provided text. The calibration and performance optimization of an immunoassay system would typically be based on a series of characterized samples and reference methods, but this is not referred to as a "training set."

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SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 diabetes control.

The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.

SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi 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 SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.

SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-the-counter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control. NFC devices contain near field communication (NFC) technology.

SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System includes:

• SD GlucoNavii® Mentor NFC Blood Glucose Meter
• SD GlucoNavii® Mentor NFC Blood Glucose Test Strips
• SD Glucose Check Strip
• SD Glucose Control Solution - Level M
• 3V Battery Type CR2032
• User Instruction Guide
• Quick Guide
• Test Strip Package Insert
• Control Solution Package Insert
• Carrying Case
• Lancing Device, Lancet

SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System includes:

• SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter
• SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips
• SD Glucose Check Strip
• SD Glucose Control Solution Level M
• 3V Battery Type CR2032
• User Instruction Guide
• Quick Guide
• Test Strip Package Insert
• Control Solution Package Insert
• Carrying Case

Optional software accessory

• GlucoNavii® DMS
• GlucoNavii®

A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.

The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format usually expected for complex medical imaging devices or AI-driven diagnostic tools. This submission is for a Blood Glucose Monitoring System, which falls under a different regulatory pathway.

However, based on the non-clinical and clinical tests performed, I can extract information related to "System Accuracy" and "User Performance Studies" as the closest equivalent to acceptance criteria and the studies performed.

Here's an analysis based on the provided text, structured to answer your questions as best as possible given the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "System accuracy evaluations (Method Comparison with Predicate Device) for the SD GlucoNavii Mentor NFC and NFC Multi Blood Glucose Monitoring Systems were performed according to ISO 15197." ISO 15197 is an international standard for in vitro diagnostic test systems for self-testing in managing diabetes mellitus. It defines minimum requirements for system accuracy.

While the exact numerical acceptance criteria from ISO 15197 are not explicitly listed in the document, it's a common standard for blood glucose meters. The document states that "The study results support that SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are substantially equivalence to other predicate devices in the market" and that the testing "met all relevant standards requirements." This implies compliance with ISO 15197.

Based on typical ISO 15197:2013 (or earlier versions like 2003, which might have been relevant in 2015) standards for system accuracy:

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The SD GlucoMentor Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The SD GlucoMentor Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 diabetes control.

The SD GlucoMentor Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The SD GlucoMentor Test Strips are for use with the SD GlucoMentor Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

The SD GlucoMentor multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoMentor multi 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 SD GlucoMentor multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The SD GlucoMentor multi Blood Glucose Test Strips are for use with the SD GlucoMentor multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

SD GlucoMentor™ blood glucose system is an Rx/OTC blood glucose monitoring system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management.

SD GlucoMentor™ blood glucose monitoring system is comprised of the following.

• SD GlucoMentor"M blood glucose meter -
• SD GlucoMentor™ blood glucose test strip -
• -SD Glucose control solution
• -SD Glucose check strip

A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.

The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning. date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

The provided text describes the SD GlucoMentor™ Blood Glucose Monitoring System, but it does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria in the format requested.

The document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone performance study with detailed acceptance criteria and results.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's a breakdown of the available information and what's not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document mentions types of testing performed (e.g., Performance Evaluation, Electromagnetic Compatibility Study (ISO 15197:2003)), but it does not specify the quantitative acceptance criteria (e.g., accuracy percentages, limits of agreement) or the precise reported device performance metrics against those criteria.

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

The document mentions:

• "A system accuracy evaluation (Method Comparison with Predicate Device) for the SD GlucoLink Blood Glucose Monitoring System was performed according to ISO 15197:2003."
• "A user performance study was performed to demonstrate that lay consumers could obtain accurate results using the SD GlucoLink Blood Glucose Monitoring System. The study was performed using capillary whole blood from fingertip, palm, forearm, and upper arm sample sites."

However, the specific sample sizes for these studies are not provided.
Data provenance (country of origin, retrospective/prospective) is also not specified. Given SD Biosensor, Inc.'s address in Korea, it's possible the studies were conducted there, but this is not stated. The studies appear to be prospective clinical studies based on the descriptions ("performed using capillary whole blood from...").

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. For blood glucose monitors, the ground truth is typically established using a reference laboratory method (e.g., YSI analyzer). Certified laboratory personnel would operate such equipment, but they are not "experts" in the sense of clinical reviewers for imaging AI.

4. Adjudication method

This information is not provided. For blood glucose measurements, adjudication methods as described (e.g., 2+1) are not typically applicable. The reference method provides the established true value.

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

No MRMC comparative effectiveness study was done. This device is a blood glucose monitoring system, which does not involve "human readers" interpreting medical images or data that an AI would assist with in the traditional sense of an MRMC study.

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

Yes, the system accuracy evaluation is a standalone performance test of the device. The "user performance study" then tests the device with human-in-the-loop (lay consumers) to ensure they can obtain accurate results, but the primary measurement is algorithmic. However, the standalone performance metrics are not detailed.

7. The type of ground truth used

The ground truth for blood glucose monitoring systems is typically established using a reference laboratory method, such as a hexokinase-based enzymatic method performed on a YSI analyzer or similar highly accurate laboratory instrument. While not explicitly stated as "YSI," the "system accuracy evaluation (Method Comparison with Predicate Device)" implies comparison against a highly accurate reference.

8. The sample size for the training set

This information is not applicable/not provided. Blood glucose monitoring systems typically rely on established electrochemical principles calibrated during manufacturing; they are generally not "trained" on large datasets in the way a machine learning algorithm for image analysis would be.

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

This information is not applicable/not provided for the reasons mentioned in point 8.

Summary of Missing and Provided Information:

This 510(k) summary focuses on demonstrating equivalence to an existing device rather than providing a detailed performance report with specific acceptance criteria and outcome data as might be found in a clinical trial publication.

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