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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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