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The GLUCOCARD W Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program.

The GLUCOCARD W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GLUCOCARD® W Blood Glucose Monitoring System is designed to quantitatively determine glucose concentrations in fresh capillary whole blood samples. The GLUCOCARD® W Blood Glucose Monitoring System consists of a battery-powered GLUCOCARD® W Blood Glucose Meter, disposable GLUCOCARD® W Blood Glucose Test Strips and Assure® Control-Control Solution (Levels 1, 2, and 3). The GLUCOCARD® W Blood Glucose Monitoring System utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Although capillary blood samples are used for measurement, the results displayed on the GLUCOCARD® W Blood Glucose Monitoring System are equivalent to plasma glucose levels.

The biosensor (GLUCOCARD® W Blood Glucose Test Strips) operates on the electrochemical detection of the reaction of glucose with the enzyme glucose oxidase.

Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current. The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates your glucose level.

The document describes the performance testing of the GLUCOCARD® W Blood Glucose Monitoring System, an in vitro diagnostic device. The acceptance criteria and supporting studies are detailed below, primarily focusing on the accuracy of blood glucose measurements.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the accuracy of blood glucose measurements are derived from the 2016 FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. The reported device performance is based on the Finger-Stick Data Accuracy and Alternate Site (Palm) Data Accuracy studies.

Accuracy at Extreme Glucose Values:
For extreme glucose values (below 80 mg/dL and greater than 250 mg/dL), 100% of the data points were within 15% of the reference analyzer result, meeting the 2016 FDA Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.

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

• Finger-stick Data Accuracy:
  • Sample Size: 300 lay-user participants.
  • Data Provenance: Not explicitly stated regarding country of origin, but the studies were performed by ARKRAY, Inc., based in Japan, and presented to the FDA in the USA. The study design is prospective, involving user performance.
• Alternate Site (Palm) Data Accuracy:
  • Sample Size: 240 lay-user participants.
  • Data Provenance: Not explicitly stated regarding country of origin, but the studies were performed by ARKRAY, Inc., and presented to the FDA in the USA. The study design is prospective, involving user performance.
• Precision (Within-Run & Intermediate):
  • Sample Size: 1,500 test strips (500 per test strip lot, 300 per glucose level) for both within-run and intermediate precision. Venous whole blood samples were spiked with glucose for within-run, and glucose control solutions were used for intermediate precision.
  • Data Provenance: Not specified, likely internal laboratory testing.
• Linearity:
  • Sample Size: 330 test strips (across 3 lots). Venous whole blood samples spiked with glucose.
  • Data Provenance: Not specified, likely internal laboratory testing.
• Accuracy at Extreme Glucose Values:
  • Sample Size: 100 prepared capillary whole blood samples (50 below 80 mg/dL and 50 above 250 mg/dL).
  • Data Provenance: Not specified, likely internal laboratory testing.
• Interference:
  • Sample Size: Not explicitly stated as a single number of samples, but involved 27 endogenous and exogenous substances tested with venous blood samples at three glucose levels (approx. 60, 120, and 250 mg/dL). Each sample was divided into test and control pools.
  • Data Provenance: Not specified, likely internal laboratory testing.
• Hematocrit:
  • Sample Size: 12 blood samples with varying hematocrit levels (20%-70%), each containing five glucose levels. A single glucose determination was made using 3 different lots of test strips with 10 different meters, resulting in 30 replicates per sample aliquot.
  • Data Provenance: Not specified, likely internal laboratory testing.
• Environmental Conditions:
  • Sample Size: Not explicitly stated as a single number of samples, but involved 10 meters and 3 test strip lots with venous whole blood samples at 3 glucose levels tested under various temperature and humidity conditions.
  • Data Provenance: Not specified, likely internal laboratory testing.
• Altitude Effects:
  • Sample Size: 360 tests (across 10 meters per test strip lot, 3 test strip lots, 6 blood glucose levels, 2 sample replicates per blood glucose level).
  • Data Provenance: Tested under real-life altitude conditions at sea level and at 10,335 feet (3,150 meters) above sea level. Not specified where these locations are.
• Error Codes for Samples Outside Measuring Range:
  • Sample Size: Not explicitly stated as a single number of samples, but involved venous blood samples with two glucose levels (≤ 10 mg/dL and 650-700 mg/dL) tested using 3 different lots of test strips with 10 different meters.
  • Data Provenance: Not specified, likely internal laboratory testing.
• Short Sample Detection:
  • Sample Size: Not explicitly stated.
  • Data Provenance: Not specified, likely internal laboratory testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The ground truth for glucose measurements was established using a "YSI comparator" or "YSI reference analyzer" (YSI 2300 Biochemistry Analyzer). This is a laboratory-grade, highly accurate instrument for glucose measurement, considered the gold standard for glucose reference values in such studies. No human experts (e.g., radiologists) were involved in establishing the ground truth for glucose levels; it was an instrumental measurement.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The ground truth is established by a reference instrument (YSI 2300), not by human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic aids where human readers interpret medical images with and without AI assistance (e.g., radiology AI). The GLUCOCARD® W Blood Glucose Monitoring System is a quantitative measurement device, not an image interpretation or AI-assisted diagnostic tool in that context. The "lay-user Participants" are performing the test themselves; their performance is compared against the reference method (YSI 2300), not against other human readers or AI output.

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

While the device's measurement principle (biosensor technology) is an "algorithm" in a broad sense, the performance studies described are inherently "human-in-the-loop" studies as they involve user operation (lay-users performing finger-stick and palm tests). The precision, linearity, interference, and extreme glucose values studies evaluate the meter and test strip system's performance, which can be seen as representing the "standalone" analytical performance of the device components when operated under controlled conditions, but always with a human providing the sample. The YSI 2300 reference analyzer itself serves as the "standalone" benchmark against which the device's output is compared.

7. The Type of Ground Truth Used

The ground truth used for all performance tests (accuracy, linearity, extreme values, interference, hematocrit, altitude, error codes) was established using a YSI 2300 Biochemistry Analyzer. This is an outcomes-based, highly accurate instrumental reference method considered a gold standard for glucose measurements.

8. The Sample Size for the Training Set

The document describes performance testing for device validation and substantial equivalence, not the development or "training" of an AI algorithm or a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of GLUCOCARD® W Blood Glucose Test Strips involves calibration and quality control, but the document does not specify a "training set" in the sense of data used to train a statistical model or algorithm.

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

As there is no "training set" in the AI/ML context, this question is not applicable. For the device itself, the "ground truth" for calibration and internal performance parameters would be established through a rigorous manufacturing and quality control process, likely referencing traceable standards and highly accurate laboratory methods such as the YSI 2300. The document mentions "Automatic coded calibration" for the meter, implying an internal calibration curve is established during manufacturing.

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