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The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EG V1 Pro meter and the EG Pro Test Strips. The EG V1 Pro meter only is used with the EG Pro Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip.

EG Glucose Control Solution: For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The EG V1 (BL) Self Monitoring Blood Glucose Test System is intended for the quantiatative measurement of glucose in fresh capillary whole blood from the fingertip, palm or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter[OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.

The system consists of the EG V1 (BL) meter and the EG V1 Test Strips. The EG V1 (BL) meter only is used with the EG V1 Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip, palm, or forearm.

EG Glucose Control Solution: For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The EG V1 Pro Self-Monitoring Blood Glucose System consists of the EG V1 Pro Blood Glucose Meter, EG Pro Glucose Test Strips, single-use Lancing Device and EG Level 2 Control Solution.

The EG V1 (BL) Self-Monitoring Blood Glucose System consists of the EG V1 (BL) Blood Glucose Meter, EG Glucose Test Strips, Auto-Lancet Device and EG Level 2 Control Solution.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the EG V1 Pro Self-Monitoring Glucose Test System and the EG V1 (BL) Self Monitoring Glucose Test System, based on the provided 510(k) Summary.

Key Observation: The document contains two separate 510(k) summaries for two devices:

EG V1 Pro Self Monitoring Glucose Test System: Intended for professional use, measuring glucose in venous or capillary whole blood from the fingertip.
EG V1 (BL) Self Monitoring Glucose Test System: Intended for Over-The-Counter (OTC) / home use, measuring glucose in capillary whole blood from fingertip, palm, or forearm.

Both summaries reference the same performance characteristics data, indicating that the underlying technology and analytical performance studies likely apply to both, with clinical accuracy studies differing based on professional vs. patient use and anatomical sites. I will present the acceptance criteria and study details as they apply to the respective devices and their specific accuracy studies.

EG V1 Pro Self Monitoring Glucose Test System (Professional Use)

1. Table of Acceptance Criteria and Reported Device Performance (Professional Use)

The acceptance criteria for system accuracy are based on ISO 15197:2003.

Performance Metric	Acceptance Criteria (ISO 15197:2003)	Reported Device Performance (Professional Use)	Meets Criteria?
System Accuracy (Professional Use)
For Glucose < 75 mg/dL	95% of individual glucose results to be within ±15 mg/dL of the laboratory reference method.	100% (19/19) of individual glucose results were within ±15 mg/dL of the YSI 2300D analyzer for glucose concentrations < 75 mg/dL from fingertip samples. (Also reported: 84.21% within ±5mg/dL, 89.47% within ±10mg/dL).	Yes
For Glucose ≥ 75 mg/dL	95% of individual glucose results to be within ±20% of the laboratory reference method.	98.51% (132/134) of individual glucose results were within ±20% of the YSI 2300D analyzer for glucose concentrations ≥ 75 mg/dL from fingertip samples. (Also reported: 76.12% within ±5%, 93.28% within ±10%, 96.27% within ±15%).	Yes
Hematocrit Interference	Bias ≤ 15 mg/dL when glucose concentration <75 mg/dL and bias ≤ 15% when glucose concentration ≥75 mg/dL (for hematocrit ranges 20-60%)	Max % Bias reported for different hematocrit levels (20%, 30%, 41%, 49%, 60%) across two strip lots: 11.5% and 13.1% (all within 15%). Specific bias for <75 mg/dL not explicitly stated in table but implied to meet criteria as max % bias is given for the overall range.	Yes
Reportable Range	Not explicitly stated as a numerical acceptance criterion, but implied to be validated.	20-600 mg/dL	Validated
Precision (Within-run)	Not explicitly stated as a numerical acceptance criterion in the provided text.	CV (%) ranged from 2.7% to 6.5% across 6 glucose concentration ranges. SD (mg/dL) ranged from 2.6 to 13.9.	N/A
Precision (Day-to-Day)	Not explicitly stated as a numerical acceptance criterion in the provided text.	CV (%) ranged from 2.1% to 7.5% across 3 control solution levels. SD (mg/dL) ranged from 3.1 to 7.2.	N/A
Linearity (R2)	Not explicitly stated as a numerical acceptance criterion in the provided text.	0.9973 (Linear regression slope 0.9809, Y-intercept 0.8180)	N/A

2. Sample Size and Data Provenance (for System Accuracy / Method Comparison Study)

Test Set Sample Size: 153 diabetes patients.
Data Provenance: Not explicitly stated (e.g., country of origin), but implies a multi-site study ("at three sites"). The study is prospective as it involves taking blood samples from diabetes patients for comparison.

3. Number of Experts and Qualifications for Ground Truth (System Accuracy)

Number of Experts: Not explicitly stated, however, the "healthcare professional" at the study sites performed tests using the EG V1 Pro meter and the YSI 2300 analyzer. The YSI 2300D analyzer is the reference method, which is a laboratory instrument.
Qualifications of Experts: "Healthcare professional" is mentioned. Additional specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. Given it's a glucose measurement, these would likely be laboratory technicians or nurses/medical staff trained in sample collection and operation of the reference device.

4. Adjudication Method (Test Set)

None. The ground truth is established by a single, traceable laboratory reference method (YSI 2300D analyzer) for each sample. Measurements from the EG V1 Pro meter are then compared directly to this reference.

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

No. This type of study is typically for evaluating the diagnostic performance of a device when interpreted by multiple human readers (e.g., radiology images). For a quantitative self-monitoring blood glucose system, comparing human interpretation of cases is not applicable. The comparison is between the device's numerical output and a laboratory reference.

6. Standalone Performance (Algorithm Only)

Yes. The system accuracy study directly compares the results from the EG V1 Pro meter (algorithm only, without human interpretation for the result itself) against the reference method.

7. Type of Ground Truth Used

Reference Method (Laboratory Analyzer): The YSI 2300D analyzer served as the ground truth. This is a common and accepted clinical laboratory method for glucose measurement.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The studies described are performance validation studies for the device itself.
- Analytical Performance (Precision): 200 tests per range for within-run (total 1200+ for 6 ranges), 400 tests for day-to-day precision.
- Analytical Performance (Linearity): 630 tests in three test strip lots.
- Analytical Performance (Hematocrit Interference): 40 tests per hematocrit level (total of 400 for 10 levels across 2 lots).
- System Accuracy (Clinical Study): 153 diabetes patients.

9. How Ground Truth for Training Set was Established

As a traditional quantitative measurement device, it's unlikely to have a "training set" in the machine learning sense. The device's calibration and analytical performance would be established through a series of experiments using known glucose concentrations and reference methods. For the analytical studies (precision, linearity, hematocrit interference), the ground truth was established by:
- Known glucose concentrations (glucolyzed/spiked venous blood).
- The YSI 2300D analyzer as the reference method, traceable to NIST 965b.

EG V1 (BL) Self Monitoring Glucose Test System (Over-The-Counter / Home Use)

1. Table of Acceptance Criteria and Reported Device Performance (Patient Use)