(88 days)
The CareSens N Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens N Voice Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Voice Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The CareSens Control Solutions are for use with the CareSens N Voice Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
The CareSens N Voice Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood sample by the meter using a small electrical current generated in the test strips. The system consists of the following: the CareSens N Voice Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), Lancing Device, Lancets, User's manual, Quick reference guide, and Logbook.
Here's a breakdown of the acceptance criteria and study information for the CareSens N Voice Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" against those criteria in a table format. Instead, it focuses on general equivalency and validation. However, we can infer that the device had to meet performance expectations comparable to its predicate device (CareSens N BGMS, K083468).
The document states:
- "Assessment of Performance Characteristics: When compared with the predicate device (CareSens N BGMS, K083468), the basic features of the CareSens N Voice BGMS (including the intended use, glucose level measuring principle, and fundamental scientific technology) are the same."
- "validation testing including the meter function test and system accuracy test were conducted."
- "The test results confirmed that the modified features operated properly when compare to the predicate device (CareSens N BGMS, K083468)."
- "CareSens N Voice BGMS demonstrated satisfactory performance and is suitable for its intended use."
Without specific numerical performance metrics (e.g., accuracy percentages, bias, precision), a direct table of acceptance criteria vs. performance cannot be fully constructed from this document. It implies that the "meter function test" and "system accuracy test" were designed to demonstrate performance comparable or equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "validation testing including the meter function test and system accuracy test were conducted." However, it does not provide any specific sample sizes for these tests for either the test set or the training set.
The provenance is implied to be from the manufacturer's testing, located in Seoul, Korea. It is a prospective study in the sense that the testing was conducted specifically for this 510(k) submission to validate the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the "system accuracy test." For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the same way as image interpretation.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. Given the nature of blood glucose measurement, where ground truth is typically established by a precise laboratory reference method, adjudication by multiple human readers/experts is generally not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation where human readers are involved. For a blood glucose meter, the evaluation focuses on the accuracy and precision of the device itself against a reference standard.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the "system accuracy test" and "meter function test" are standalone performance evaluations of the device (meter and test strip system) without human intervention in the measurement process itself, beyond the initial blood application. The device is designed for standalone measurement when used by patients.
7. The Type of Ground Truth Used
The type of ground truth for blood glucose meters like this is typically established by comparing the device's readings against laboratory reference methods (e.g., YSI analyzer, hexokinase method). The document doesn't explicitly name the reference method used but refers to "system accuracy test," which implies comparison against a highly accurate reference.
8. The Sample Size for the Training Set
The document does not provide any specific sample sizes for a training set. This device relies on a pre-established electrochemical principle and a standard curve. While there might have been initial calibration data (which could be considered a "training set" in a broad sense), the submission doesn't detail it in terms of size or methodology. The validation focuses on the performance of the modified device.
9. How the Ground Truth for the Training Set Was Established
As with point 8, the document does not provide details on how ground truth was established for any potential "training set." For an electrochemical glucose meter, the "ground truth" for calibration curves would be established by measuring glucose solutions of known concentrations using the same highly accurate laboratory reference methods mentioned in point 7.
§ 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.