(88 days)
VivaChek™ Link Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips.
VivaChek™ Link Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek Link Plus Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
VivaChek Link Plus Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 2, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.
The provided text describes the VivaChek™ Link Plus Blood Glucose Monitoring System, an in-vitro diagnostic device. Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. Instead, it states that various laboratory studies were performed, and for these studies, "the test results indicated that the acceptance criteria were met."
Therefore, based on the provided text, a generic representation of this would be:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly detailed in text) | Reported Device Performance |
|---|---|---|
| Accuracy (User Evaluation) | [e.g., ISO 15197:2013 standards for accuracy] | "able to obtain blood glucose readings" |
| Precision | [e.g., CV% within specified limits] | "acceptance criteria were met" |
| Linearity | [e.g., R-squared > 0.99] | "acceptance criteria were met" |
| Interference | [e.g., no significant bias from common interferents] | "acceptance criteria were met" |
| Usability/Ease of Operation | [e.g., users can successfully perform tests, satisfaction] | "satisfied with the ease of operation... and the overall performance" |
| Stability | [e.g., device functions effectively over time] | "acceptance criteria were met" |
| Environmental Conditions | [e.g., functional across specified temperature/humidity] | "acceptance criteria were met" |
| Safety (Electrical, EMC, etc.) | [e.g., complies with relevant standards] | "acceptance criteria were met" |
| Cybersecurity | [e.g., controls in place, management plan] | "FCC, cybersecurity control DFMEA, Cybersecurity Management Plan and Web App software validation were conducted." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "clinical study (user evaluation) was conducted with intended users." However, it does not specify the number of users or samples included in this evaluation.
- Data Provenance: The document does not explicitly state the country of origin for the data. It also directly states that the user evaluation was conducted as a "clinical study," implying it was a prospective study, though not explicitly labelled as such. The other laboratory studies listed are implicitly prospective tests performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" for glucose levels would typically be established using a laboratory reference method (e.g., a YSI analyzer), not by human experts interpreting results. The user evaluation focuses on the usability and ability of lay persons to obtain readings, not on expert interpretation of the device's output.
4. Adjudication method for the test set
This information is not applicable/provided in the context of this device. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers interpret images or complex data to establish a consensus ground truth, often for AI-assisted diagnostic tools. For a blood glucose meter, the reference method (e.g., YSI) provides the objective ground truth, and device readings are compared directly to this.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI where human readers interact with AI assistance. The VivaChek™ Link Plus Blood Glucose Monitoring System is a standalone measurement device for self-testing; it does not involve human readers interpreting AI-generated insights.
- Effect size of improvement with AI vs without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was done. The entire suite of laboratory studies (e.g., precision, linearity, interference, stability, environmental, safety) represents the standalone performance evaluation of the device system (meter and test strips) without human interpretation in the loop. The "user evaluation" section primarily assesses usability rather than the intrinsic accuracy of the algorithm/device itself. The device is designed for "self-testing outside the body (in vitro diagnostic use)," operating without professional human-in-the-loop interpretation of its results for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the specific reference method used for establishing ground truth for glucose levels. However, in the context of blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which provides highly accurate and precise glucose concentration measurements. This is an objective chemical measurement, not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not provided and is generally not applicable in this context. Blood glucose monitoring systems are typically designed and calibrated based on biochemical principles and rigorous testing, rather than "training" a machine learning algorithm with a dataset in the way an AI diagnostic tool would be trained. The "training set" concept is usually associated with AI/ML development.
9. How the ground truth for the training set was established
As noted above, a "training set" in the AI/ML sense is likely not applicable here. Device calibration and verification are based on established analytical chemistry methods where the "ground truth" for glucose concentrations in control solutions or reference samples would be determined using highly accurate laboratory reference instruments.
§ 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.