(27 days)
The GlucoLeader Enhance Self-Monitoring of Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
The GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System is comprised of two main parts a bio-active electrode (test strip) containing the enzyme glucose oxidase and the glucose meter. The blood sample is drawn into the Test Strip through capillary action. Glucose in the sample reacts with glucose oxidase and potassium ferricyanide in the strip, producing ferrocyanide. Potassium ferrocyanide is produced in proportion to the glucose concentration of the blood sample. Oxidation of the potassium ferrocyanide produces an electrical current which is then converted by the meter to display the glucose concentration.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated in terms of specific performance thresholds (e.g., a certain percentage of readings within a specific range). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (GlucoLeader™ Value Self-Monitoring of Blood Glucose System) through strong correlation.
Therefore, the "acceptance criteria" inferred from the document is the demonstration of a strong linear correlation (R > 0.98) and low standard error of the estimate (Sy.x) within the specified glucose measurement range (40-400 mg/dL or 64-539 mg/dL) when compared to a reference method (YSI) for lay users and technicians, and when compared to the predicate device (GlucoLeader™ Value) in point-of-care settings.
| Performance Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (GlucoLeader™ Enhance) |
|---|---|---|
| Consumer Study | ||
| Correlation (R) vs. YSI (Lay Users) | > 0.98 | 0.987 |
| Sy.x vs. YSI (Lay Users) | Low (relative to predicate/clinical needs) | 13.65205 |
| Range (Lay Users) | 40-400 mg/dL (or similar) | 64-539 mg/dL |
| Correlation (R) vs. YSI (Technician) | > 0.98 | 0.981 |
| Sy.x vs. YSI (Technician) | Low (relative to predicate/clinical needs) | 19.0268 |
| Range (Technician) | 40-400 mg/dL (or similar) | 68-539 mg/dL |
| Point-of-Care Study | ||
| Correlation (R) vs. GlucoLeader™ Value (Total) | > 0.98 | 0.986 |
| Sy.x vs. GlucoLeader™ Value (Total) | Low (relative to predicate/clinical needs) | 13.78 |
| Range (Total) | 40-400 mg/dL (or similar) | 68-411 mg/dL |
| Measuring Range | 30-600 mg/dL | 30-600 mg/dL (claimed to be similar to predicate) |
| Acceptable Hematocrit Range | 30-50 % | 30-50 % (claimed to be similar to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Consumer Study:
- Sample Size: 180 specimens for lay users and 180 specimens for technicians.
- Data Provenance: Conducted at "clinical centers." The country of origin is not explicitly stated, but the submitter is HMD Biomedical Inc. from Taiwan. The mention of "clinical centers" suggests a prospective collection for this study, though it's not explicitly stated as "prospective."
- Point-Of-Care Study:
- Sample Size: 150 specimens (50 each from Home Medical, Metabolism, and Internal departments).
- Data Provenance: Conducted at "department of Home Medical, Internal, and Metabolism." Similar to the consumer study, the country of origin is not explicitly stated. This appears to be prospective data collection in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Ground Truth Method: The primary ground truth for the consumer study was established using the YSI (Yellow Springs Instruments) method, which is a laboratory reference method for glucose measurement. For the point-of-care study, the predicate device, GlucoLeader™ Value, served as the comparative reference.
- Experts: The document does not specify a "number of experts" in the context of establishing ground truth for the test set by consensus or interpretation (e.g., radiologists). The ground truth was primarily obtained via instrument-based reference methods (YSI) and the predicate device. For the "technician" comparison in the consumer study, it's implied that trained medical technicians operated the GlucoLeader Enhance device and that their readings were compared to the YSI reference. Their qualifications are not further detailed beyond "technician."
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by objective measurements from reference instruments (YSI) or by comparison to the predicate device, not through expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes studies to evaluate the standalone performance and substantial equivalence of a glucose meter, not a comparative effectiveness study involving multiple human readers using an AI vs. without AI assistance. The device is a self-monitoring blood glucose system, not an AI diagnostic tool that assists human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies presented are essentially standalone performance evaluations of the GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System.
- The "Consumer Study" compares the device's output (when used by lay users or technicians) directly against a definitive reference method (YSI).
- The "Point-of-Care Study" compares the device's output against a predicate device.
In both cases, the performance being assessed is that of the device itself.
7. Type of Ground Truth Used
- Consumer Study Ground Truth: Objective reference method measurements from a YSI instrument (a laboratory analyzer for glucose).
- Point-of-Care Study Ground Truth: Comparative measurements from the GlucoLeader™ Value predicate device.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or how the device's algorithms (if any beyond basic signal processing and conversion) were developed or trained. This submission focuses on the performance of a final, manufactured device. Glucose meters typically use pre-calibrated algorithms established during development, not "trained" in the machine learning sense on a distinct training dataset for each submission.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set information is provided or implied for this type of device in the document.
§ 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.