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510(k) Data Aggregation
(336 days)
The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared.
The OneTouch Verio Sync BGMS is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch Verio Sync BGMS should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch Verio Test Strips are for use with the OneTouch Verio Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The OneTouch® Verio™ Sync Blood Glucose Monitoring System consists of the OneTouch® Verio™ Sync Blood Glucose Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio™ Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio™ Sync Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for OneTouch Verio Sync Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the requirements of ISO 15197:2003(E) for system accuracy. The provided text details two levels of accuracy checks: against a laboratory reference method (YSI) and a user performance evaluation with fingertip blood samples.
System Accuracy (Against Laboratory Reference - YSI)
| Glucose Concentration Range | Acceptance Criteria (Implied by ISO 15197:2003(E) - General Guidance) | Reported Device Performance (Number and Percent of Meter Results Matching Laboratory Test) |
|---|---|---|
| <75 mg/dL | For < 75 mg/dL, at least 95% of all results shall be within ±15 mg/dL of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003) | Within ±15 mg/dL: 57/57 (100%) |
| Within ±5 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5 mg/dL: 40/57 (70%) | |
| Within ±10 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10 mg/dL: 55/57 (96%) | |
| ≥75 mg/dL | For ≥ 75 mg/dL, at least 95% of all results shall be within ±20% of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003) | Within ±20%: 243/243 (100%) |
| Within ±5%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5%: 174/243 (72%) | |
| Within ±10%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10%: 235/243 (97%) | |
| Within ±15%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±15%: 242/243 (99.59%) |
Total Precision (Based on Control Solution Tests)
| Glucose Level Ranges (mg/dL) | Acceptance Criteria (Typically CV < 5% for control solutions, but not explicitly stated as such in filing. The reported values are generally acceptable for devices of this type.) | Reported Device Performance (Coefficient of Variation (%)) |
|---|---|---|
| Low (38-62) | No explicit threshold for acceptance stated in the document. | 2.27 |
| Mid (102-138) | No explicit threshold for acceptance stated in the document. | 1.70 |
| High (298-403) | No explicit threshold for acceptance stated in the document. | 1.86 |
User Performance Evaluation (Subject Fingertip Results)
| Glucose Concentration Range | Acceptance Criteria (Implied by ISO 15197:2003(E) - General Guidance for lay-user testing) | Reported Device Performance (Number and Percent of Meter Results Matching Laboratory Test) |
|---|---|---|
| <75 mg/dL | For < 75 mg/dL, at least 95% of all results shall be within ±15 mg/dL of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003 for user performance testing) | Within ±15 mg/dL: 22/23 (96%) |
| Within ±5 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5 mg/dL: 5/23 (22%) | |
| Within ±10 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10 mg/dL: 15/23 (65%) | |
| ≥75 mg/dL | For ≥ 75 mg/dL, at least 95% of all results shall be within ±20% of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003 for user performance testing) | Within ±20%: 248/250 (99%) |
| Within ±5%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5%: 141/250 (56%) | |
| Within ±10%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10%: 219/250 (88%) | |
| Within ±15%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±15%: 242/250 (97%) |
Note: The document states that the testing was performed in accordance with ISO 15197:2003(E). While the specific acceptance thresholds (e.g., "95% of results within...") are not explicitly listed in the provided text as "acceptance criteria," they are inherent to meeting the ISO standard. The reported performance values demonstrate that the device met or exceeded these implicit acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size for System Accuracy (Against Lab Reference):
- Glucose <75 mg/dL: 57 samples
- Glucose ≥75 mg/dL: 243 samples
- Total for System Accuracy: 300 samples (57 + 243)
- Test Set Sample Size for User Performance Evaluation:
- Glucose <75 mg/dL: 23 samples
- Glucose ≥75 mg/dL: 250 samples
- Total for User Performance: 273 samples (23 + 250)
- Test Set Sample Size for Total Precision: 600 control solution tests.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a medical device cleared in the US (FDA), it is highly probable that the studies were conducted in accordance with good clinical practice and likely involved prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this device. The ground truth for glucose measurements is established by a laboratory reference method, specifically the Yellow Springs Instrument (YSI).
- Qualifications of Experts: Not applicable. The YSI is a highly accurate and standardized laboratory instrument used for reference glucose measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth is established by a quantitative laboratory reference method (YSI), which does not typically involve human expert adjudication for determining values. The comparison is directly between the device's reading and the YSI's reading.
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 is more common for diagnostic imaging devices where human readers interpret images. For a blood glucose monitoring system, the focus is on the accuracy and precision of the numerical measurement provided by the device, both in a lab setting and by a single lay user. The "user performance evaluation" assesses accuracy and usability, not reader improvement with AI assistance.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable as it wasn't an MRMC study with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The "System Accuracy" section (Page 4) directly compares the OneTouch® Verio™ Sync Blood Glucose Monitoring System's results to a laboratory reference method (YSI). This is a standalone assessment of the device's (meter, strips, and control solutions) accuracy without direct human interpretation influencing the measurement itself, beyond applying the blood sample and following test procedure.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for glucose concentrations was established using a laboratory reference method, specifically the Yellow Springs Instrument (YSI). This is a highly accurate and precise method for determining glucose levels in blood samples.
8. The Sample Size for the Training Set
- The document does not explicitly state a separate sample size for a training set. For a blood glucose monitoring system, particularly one cleared via 510(k) as "substantially equivalent," the focus is on verification and validation testing rather than large-scale training of an artificial intelligence algorithm in the way a machine learning device would require. The system's underlying electrochemical reaction and algorithms are inherent to its design and calibrated during manufacturing. Therefore, there isn't a "training set" in the sense of a dataset used to train a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- As mentioned in point 8, a distinct "training set" for a machine learning algorithm is not detailed or implied in the submission. The device's operational principles are based on established electrochemical sensing technology. Any internal calibration or algorithm development would have relied on highly controlled glucose standards and reference methods during the device's engineering and design phases. The "ground truth" for the device's development and calibration would similarly be laboratory reference methods, but the specific details and dataset sizes for this are not provided in the 510(k) summary.
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