(16 days)
The FastTake® Compact Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The FastTake® System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.
The FastTake® system includes four main components:
- FastTake® Test Strips .
- FastTake® Compact Blood Glucose Meter
- FastTake® Control Solution
- Penlet II or Penlet Plus lancing device and FinePoint lancets.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the FastTake® Compact Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating equivalence to a predicate device, rather than explicit pre-defined "acceptance criteria" for performance. However, based on the Summary of Performance Data provided, we can infer the key performance metrics evaluated and their reported results. The predicate device's performance would serve as the implicit acceptance benchmark.
| Performance Metric | Implied Acceptance Criteria (relative to predicate) | Reported Device Performance (Modified FastTake®) |
|---|---|---|
| Precision | Demonstrates equivalent or better precision at various glucose levels. | Glucose Level 1 (62 mg/dL): SD=1.1 mg/dL, CV=1.7% |
| Glucose Level 2 (87 mg/dL): SD=3.5 mg/dL, CV=4.0% | ||
| Glucose Level 3 (152 mg/dL): SD=3.2 mg/dL, CV=2.1% | ||
| Glucose Level 4 (220 mg/dL): SD=6.3 mg/dL, CV=2.9% | ||
| Glucose Level 5 (378 mg/dL): SD=9.1 mg/dL, CV=2.4% | ||
| (Compared to unmodified FastTake®, indicating equivalence) | ||
| Accuracy (Professional Users vs. YSI) | Equivalent accuracy as measured against a reference method (YSI) | n = 238 |
| $y = 1.04x - 9.2$ | ||
| r = 0.988 | ||
| Sy·x = 13.5 | ||
| Range = 44 to 425 mg/dL | ||
| Accuracy (Lay Users vs. YSI) | Equivalent accuracy as measured against a reference method (YSI) | n = 119 |
| $y = 1.03x - 5.2$ | ||
| r = 0.982 | ||
| Sy·x = 16.69 | ||
| Range = 46 to 425 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Study (Laboratory Study):
- Sample Size: 20 samples (n=20) for each of the 5 glucose levels.
- Data Provenance: The document states "A laboratory study," implying an in-house or controlled laboratory setting. It does not specify the country of origin or whether it's retrospective or prospective, but such laboratory studies are typically prospective.
- Accuracy Study (Clinical Centers):
- Professional Users: n = 238.
- Lay Users: n = 119.
- Data Provenance: "clinical centers" (plural, suggesting multiple sites). The context implies these are prospective clinical studies. The country of origin is not explicitly stated, but the submission is to the US FDA, making it highly probable the studies were conducted in the US or under US regulatory standards. The participants were "people with diabetes."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (blood glucose monitor) does not typically rely on human expert interpretation for ground truth. The gold standard for glucose measurement is usually a highly accurate laboratory reference method.
- Ground Truth Method: The text explicitly states "Accuracy of Professional users compared to YSI" and "Accuracy of Lay users compared to YSI." YSI (Yellow Springs Instruments) is a well-known brand for laboratory-grade glucose analyzers, serving as the reference method or "ground truth" in these studies.
- Number/Qualifications of Experts: Not applicable, as the ground truth was established by laboratory instrumentation (YSI), not human experts.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used when human experts are establishing ground truth, especially for subjective assessments (e.g., image interpretation). Since the ground truth was instrumental (YSI), no human adjudication method was needed or performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is relevant for diagnostic imaging AI devices where human interpretation is a primary component. For a blood glucose monitor, the focus is on the device's direct measurement capability, both by professional and lay users, against a laboratory reference.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The performance data presented (precision and accuracy) represents the device's performance. While "lay users" and "professional users" are involved in operating the device, the metrics themselves ($y=mx+b$, r-value, S_yx, SD, CV%) are a standalone reflection of the device's measurement precision and accuracy compared to a reference standard (YSI). There isn't a separate "algorithm" being evaluated beyond the functioning of the glucose meter and test strips.
7. The Type of Ground Truth Used
The ground truth used was an objective laboratory reference method, specifically a YSI glucose analyzer. This is considered a highly accurate and precise instrumental measurement, often serving as the gold standard for glucose concentration.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device development or performance evaluation. Blood glucose monitoring systems typically do not involve machine learning algorithms that require separate training sets in the way AI/ML medical devices do. The performance data presented is from verification and validation studies on the final product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or indication of a training set as understood in AI/ML development. The ground truth for the performance studies was established by a laboratory reference instrument (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.