(119 days)
The eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Based on an electrochemical biosensor technology and the principle of capillary action, eBsensor Blood Glucose Monitoring System, eB-G only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.
The Visgeneer eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
Here's an analysis of the provided information regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or a detailed performance table from a study beyond referring to compliance with "Guidance Document for In Vitro Diagnostic Test System." Therefore, a definitive table of acceptance criteria and reported performance cannot be generated directly from the given text.
However, the document states that "A claim of substantial equivalence is made to LIFESCAN, INC. - One Touch Ultra Blood Glucose Monitoring System (K043197)." This implies that the eBsensor system's performance is expected to be comparable to or within acceptable limits of the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical data (test set). It only mentions that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System."
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. For blood glucose meters, adjudication of expert opinions is not typically relevant as the ground truth is established by a more precise laboratory method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor is there any mention of human readers improving with or without AI assistance. This type of study is not typically relevant for a blood glucose monitoring system, which measures a quantitative biomarker directly.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The eBsensor system is a standalone diagnostic device. The performance data would inherently be "algorithm only" as it provides a direct measurement from a blood sample. The document does not detail the specific standalone performance study, but the substantial equivalence claim implies that its standalone performance meets regulatory expectations compared to the predicate device.
7. Type of Ground Truth Used
The type of ground truth used would almost certainly be a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer or a similar highly accurate clinical chemistry instrument). This is standard practice for validating blood glucose monitoring systems. The document does not explicitly state the method, but it is implied by the nature of the device.
8. Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This is typical for a device using an electrochemical biosensor. While the sensor and algorithm would have been developed and calibrated with various samples, the 510(k) summary focuses on the validation of the final product with clinical data, usually referred to as the "test set" in this context even if not explicitly named.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the document, there is no information on how its ground truth was established. If there were calibration or development data, the ground truth would also have been established using a laboratory reference method.
§ 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.