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510(k) Data Aggregation
(200 days)
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING
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(28 days)
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
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(24 days)
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
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(27 days)
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING
SYSTEM
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(16 days)
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
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).
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(29 days)
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
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 regarding the FastTake® Compact Blood Glucose Monitoring System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual confirmation of sufficient blood sample on test strip | Patients detected under-filled and correctly filled strips with 99% accuracy. |
| Ability of intended users (diabetic patients) to utilize the new feature independently | Demonstrated ability of individual patients to test independently. |
| Equivalence in performance to the unmodified predicate device | Verification and validation tests demonstrate that the modified system has equivalent performance to the unmodified FastTake Compact Blood Glucose Monitoring System. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 19 diabetic patients.
- Data Provenance: The study was a "consumer-use study," implying real-world or simulated home use. The location/country of origin is not explicitly stated, but Selfcare, Inc. is located in Waltham, MA, USA, suggesting a US-based study. It was a prospective study as it evaluated users interactively with the device feature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. The study focused on consumer perception and ability to detect correct filling, implying the "ground truth" for the confirmation window's effectiveness was based on the physical state of the strip (correctly filled vs. under-filled), which would likely be objectively observable or determined by the study administrators rather than expert consensus on a diagnosis.
4. Adjudication Method for the Test Set
This information is not provided in the given text. As the "ground truth" likely related to objective observation of the test strip filling, a formal adjudication method like 2+1 or 3+1 might not have been necessary for this specific performance metric.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The study was a consumer-use study to evaluate the usability and effectiveness of a visual confirmation window, not a comparison of human reader performance with and without AI assistance for diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device, a blood glucose monitoring system, is a diagnostic device that requires human interaction (applying blood to the strip). There is no mention of a standalone algorithm-only performance study independent of human use for the FastTake® Compact Blood Glucose Monitoring System as described. The "confirmation window" is a visual aid for the user, not an automated algorithm to interpret results.
7. The Type of Ground Truth Used
The ground truth for the consumer-use study regarding the confirmation window was based on the adequacy of sample filling (i.e., whether the strip was correctly filled or under-filled). This is an objective characteristic of the test strip's physical state rather than a medical diagnosis.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is not an AI/ML-based system requiring a training set in the typical sense. The "FastTake® strips with the new confirmation window feature" were evaluated, implying a design change rather than a learned model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/ML model for this device.
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