(142 days)
Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use . by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.
Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.
The provided text describes the performance data for the Excel™ GE Blood Glucose Test Strips and Code Strip. Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" with numerical thresholds. However, it implicitly demonstrates performance through comparison with established laboratory methods (YSI) and aims for "equivalent performance" to a predicate device. Interpreting the presented data as the reported performance that met the implicit acceptance for substantial equivalence:
| Performance Metric | Reported Device Performance (Excel™ GE Blood Glucose Test Strips) |
|---|---|
| Precision | |
| Glucose Level 1 (e.g., ~45 mg/dL) | SD: 1.2 mg/dL, CV: 2.6-2.7% |
| Glucose Level 2 (e.g., ~80 mg/dL) | SD: 2.2-2.3 mg/dL, CV: 2.7-3.0% |
| Glucose Level 3 (e.g., ~150 mg/dL) | SD: 3.2-3.6 mg/dL, CV: 2.2% |
| Glucose Level 4 (e.g., ~345 mg/dL) | SD: 6.4-7.0 mg/dL, CV: 1.8-2.0% |
| Accuracy (Professional Users vs. YSI) | |
| n | 252-253 |
| Regression Equation (y = mx + b) | y = 0.91x + 0.18 to y = 0.93x + 1.24 |
| Correlation Coefficient (r) | 0.9877 - 0.9949 |
| Standard Error of Estimate (Sy.x) | 7.55 - 11.45 |
| Range | 51 - 374 mg/dL |
| Accuracy (Lay Users vs. YSI) | |
| n | 128 |
| Regression Equation (y = mx + b) | y = 0.92x + 6.99 to y = 0.95x + 3.92 |
| Correlation Coefficient (r) | 0.9883 - 0.9941 |
| Standard Error of Estimate (Sy.x) | 8.31 - 11.38 |
| Range | 51 - 374 mg/dL |
2. Sample Size for the Test Set and Data Provenance
- Precision Study:
- Sample Size: 20 for each glucose level, on each meter model (total of 20 x 4 x 2 = 160 tests, not distinct samples). The text states "20 samples" implying 20 distinct blood samples, each tested across 4 glucose levels and two meter models.
- Data Provenance: Not specified, but described as a "laboratory study."
- Accuracy Studies (Professional and Lay Users):
- Sample Size:
- Professional Users: 252 (Model 3901A) and 253 (Model 3901M) patient samples.
- Lay Users: 128 patient samples.
- Data Provenance: "128 patients with diabetes at three clinical centers." This indicates a prospective clinical study involving actual patient samples. The country of origin is not specified.
- Sample Size:
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) for measuring blood glucose. The "ground truth" is established by a reference laboratory method, not human expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established by a laboratory reference method (YSI), not through human adjudication of differing interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. This is an IVD device for measuring blood glucose, not an imaging device or AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study. The performance is assessed against a laboratory reference method and compared to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence, the device's performance (Excel™ GE Blood Glucose Test Strips used with Glucometer Elite® Glucose Meters) is evaluated in a standalone manner against the YSI laboratory reference method. The "algorithm" here is the combined chemistry and meter reading. The accuracy studies demonstrate the device's performance without human interpretation influencing the measurement result itself, though human professionals and lay users perform the blood application.
7. The Type of Ground Truth Used
- Precision Study: The "ground truth" for precision is the mean glucose value obtained by the device itself, allowing for calculation of standard deviation and coefficient of variation.
- Accuracy Studies: The "ground truth" was established using a YSI (Yellow Springs Instruments) laboratory method, which is a recognized reference standard for glucose measurement.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. For this type of IVD, the development process typically involves optimizing the strip chemistry and meter calibration using various samples, but these are not usually referred to as a "training set" in the same way as for AI. The data presented are performance validation data.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for an AI or machine learning algorithm is mentioned, this question is not directly applicable. For the development of the test strip and meter, the ground truth for calibration and initial development would also typically rely on established laboratory reference methods like YSI.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.