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510(k) Data Aggregation
(388 days)
The eBchek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The eBchek Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The eBchek Blood Glucose Monitoring System 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 eBchek Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus or for neonatal use. The eBchek Glucose Meter contains some speaking functions, but is not intended for use by the visually impaired.
eBchek Blood Glucose Test Strips are for use with the eBchek Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
eB-series Control Solutions are for use with the eBchek Blood Glucose Meter and eBchek Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Based on an electrochemical biosensor technology and the principle of capillary action, eBchek Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed on the meter. This system contains some speaking functions, but is not intended for use by the visually impaired.
The eBchek Blood Glucose Monitoring System consists of the eBchek Meter, eBchek test strips with instruction, lancing device, lancets, code card, two AAA Batteries, users manual, carrying case. eB-series control solutions (previously cleared in K062555 as eBsensor control solution) with two different glucose concentration ranges (Level 1 and Level 2) are available but sold separately.
The original text describes a medical device, the eBchek Blood Glucose Monitoring System, and its performance studies. However, the document does not include detailed acceptance criteria or a comprehensive study report with specific data provenance, sample sizes for test and training sets, expert qualifications, or adjudication methods in the way typically expected for AI/ML device descriptions.
The document states that the Performance Studies are "based on ISO 15197: In vitro diagnostic test systems- Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus." It concludes that "Performance on the eBchek Blood Glucose Monitoring System demonstrated that the device meets the requirements for its intended use" and "replicates the predicate device."
Without the full ISO 15197 study report, I cannot provide all the requested details. However, I can infer some information based on typical requirements for blood glucose monitoring systems and the provided text.
Based on the provided information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems generally follow ISO 15197. While the specific ISO 15197 table is not provided, the general performance criteria for accuracy typically involve comparing the device's readings to a laboratory reference method. The document states that the device "meets the requirements for its intended use" and "demonstrated that the device is substantially equivalent to the predicate."
A typical summary of accuracy for a blood glucose monitor under ISO 15197 would involve percentage of results within certain deviation ranges from a reference method. For self-testing devices, common accuracy criteria at the time this submission was made were:
- For glucose concentrations < 75 mg/dL (4.2 mmol/L): At least 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference value.
- For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): At least 95% of results must be within ±20% of the reference value.
Since the document states the device "meets the requirements for its intended use" and "is substantially equivalent to the predicate," it implies that the device achieved these (or similar) ISO 15197 specified accuracy targets.
| Acceptance Criteria (Inferred from ISO 15197 for accuracy) | Reported Device Performance (Inferred) |
|---|---|
| For glucose < 75 mg/dL: ≥95% results within ±15 mg/dL | Device "meets the requirements for its intended use" and is "substantially equivalent to the predicate," implying these ISO 15197 criteria are met. |
| For glucose ≥ 75 mg/dL: ≥95% results within ±20% | Device "meets the requirements for its intended use" and is "substantially equivalent to the predicate," implying these ISO 15197 criteria are met. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. ISO 15197 typically requires a minimum number of subjects (e.g., 100 for user performance accuracy) and a certain number of data points across the measurable range.
- Data Provenance: Not explicitly stated. The manufacturer is Visgeneer Inc. from Hsinchu City, Taiwan. The study was conducted based on ISO 15197. It is highly likely the data was collected in Taiwan, but this is not confirmed. It is a prospective study as it's a performance study for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a blood glucose monitoring system, not an imaging AI device requiring expert adjudication for ground truth. The "ground truth" would be established by a highly accurate laboratory reference method (e.g., YSI analyzer).
4. Adjudication method for the test set
Not applicable. Ground truth for blood glucose measurements is established by a reference laboratory method, not expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a standalone diagnostic device (blood glucose monitor), not an AI assistance tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this is a standalone performance study. The eBchek Blood Glucose Monitoring System is a device that provides a direct measurement, and its performance is evaluated on its own ability to accurately measure glucose.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., YSI Glucose Analyzer) due to its high precision and accuracy, rather than expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device in the modern sense that it requires a training set of data to learn from. Its electrochemical biosensor technology is pre-programmed, not "trained" on data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device.
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