(465 days)
MultiSure GK Link Blood Glucose and Ketone Monitoring System is comprised of the MultiSure GK Blood Glucose and Ketone Meter, the MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood Ketone test strips.
The MultiSure GK Link Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The MultiSure GK Link Blood Glucose and Ketone Monitoring System consists of the MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 and Level 3), and KET-1 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution, and KET-1 ketone control solution are purchased separately.
MultiSure GK Link Blood Glucose and Ketone Monitoring System enables automatic transmission of stored data to a data management system using upload data via USB cable (optional), or mobile device with Bluetooth when the meter and data management systems are properly configured.
The glucose test strips and glucose control solution utilized in the MultiSure GK Link Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips and Contrex Plus 4 Glucose Control Solution, previously cleared in K170267; The ketone test strips and ketone control solution are the same as the KET-1 Blood Ketone test strips and KET-1 ketone control solution, previously cleared in K182593.
Here's an analysis of the provided text, extracting information related to acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides information on the accuracy studies for both glucose and ketone measurements. The acceptance criteria for these are described in the device's previous clearances (K170267 for glucose and K182593 for ketone). While the exact numerical acceptance criteria are not explicitly stated within this specific 510(k) summary for this device (K201880), it notes that the systems used are the same as previously cleared products, implying they meet the previously established criteria. The reported performance is that the "Results demonstrate substantial equivalence to the predicate system."
Given the information available, a table would look like this:
| Measurement Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Blood Glucose | Performance criteria established in K170267 | Substantially equivalent to the predicate system (K091547) |
| Blood Ketone | Performance criteria established in K182593 | Substantially equivalent to the predicate system (K091547) |
| Ease of Use & Understanding (User Manual) | Not explicitly detailed for this 510(k), but assessed in clinical study | Substantially equivalent to the predicate system (K091547) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for the "accuracy studies for glucose and ketone" or the "evaluation of ease of use." It only mentions that these studies were "conducted with home users."
- Data Provenance: Not specified within this document. The submitter is from Hsinchu, Taiwan, but the location where the clinical studies were performed is not mentioned. It is prospective, as it involves human participants (home users) in a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For blood glucose and ketone monitoring systems, ground truth is typically established by comparative measurements against a laboratory reference method, not necessarily by expert consensus in the way a diagnostic imaging study might.
4. Adjudication Method for the Test Set:
Not applicable or specified. For glucose and ketone measurements, adjudication methods (like 2+1, 3+1) are typically used for qualitative or imaging-based assessments where human interpretation is involved. For quantitative measurements against a reference standard, direct comparison is the method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance, particularly in imaging diagnostics. This device is a quantitative blood analyzer for self-testing, so this type of study is not relevant.
6. Standalone Performance (Algorithm Only Without Human-in-the-loop Performance):
Yes, a standalone performance study was done for the device itself. The "accuracy studies for glucose and ketone" assess the performance of the device (meter and test strips) in measuring blood glucose and ketone levels. While performed by "home users," the focus is on the device's ability to provide accurate readings, not on human interpretation of those readings.
7. Type of Ground Truth Used:
For the "accuracy studies for glucose and ketone," the ground truth would typically be established by a laboratory reference method. This is standard for quantitative diagnostic devices like blood glucose and ketone meters, where the device's readings are compared against a highly accurate and precise laboratory analyzer. The document states "accuracy studies," which implies comparison to a gold standard.
8. Sample Size for the Training Set:
The document does not provide information on the sample size for a training set. This is often not explicitly detailed for diagnostic devices that rely on established electrochemical biosensor technology, as opposed to devices employing complex machine learning or AI models that require extensive "training" data. The technology itself (Glucose Oxidase for glucose, $\beta$-hydroxybutyrate dehydrogenase for ketone) is well-understood and the "training" would have been part of the initial development and calibration of the test strips and meter, not necessarily a distinct "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
As with point 8, the concept of a "training set" and its associated ground truth establishment isn't directly applicable in the same way for this type of device as it would be for an AI/ML diagnostic. The ground truth for the development and calibration of the technology would have been established through rigorous laboratory testing using reference methods and known concentrations of glucose and ketone.
§ 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.