(252 days)
The Contour® Next ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® Next ONE 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 in monitoring the effectiveness of a diabetes control program.
The Contour® Next ONE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm.
The system is intended for in vitro diagnostic use only.
CONTOUR® NEXT ONE Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to a mobile smart device. The meter uses the CONTOUR NEXT test strips and CONTOUR NEXT control solution. It utilizes a similar algorithm to the one used in the CONTOUR NEXT USB blood glucose meter, but this algorithm has been enhanced for even better accuracy. The meter has a 7-segment display and icons in the display to aid the user with the features of the meter. It uses two replaceable CR2032 coin cell batteries. The associated CONTOUR Diabetes app is compatible with Apple iOS operating system and the Android operating system. The app communicates with the CONTOUR® NEXT ONE blood glucose meter using Bluetooth Low Energy wireless technology. Blood glucose test results are automatically sent to the mobile device for viewing and editing, and settings on the meter can be modified using the app.
The provided document is a 510(k) summary for the Contour Next ONE Blood Glucose Monitoring System. It outlines the device description, intended use, and a comparison to a predicate device (Contour Next USB Blood Glucose Monitoring System). While it mentions "Clinical trials and bench testing showed that the Contour Next One Blood Glucose Monitoring System performed as intended and met the system specifications," it does not provide detailed acceptance criteria or study results for accuracy, which would typically include metrics like bias, precision, or agreement rates against a reference method. It also does not discuss sample sizes, ground truth establishment, or expert involvement in a manner relevant to the accuracy of the blood glucose measurements.
Therefore, many of the requested details cannot be extracted from this document as they are not present.
Here's what can be extracted:
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A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states "Clinical trials and bench testing showed that the Contour Next One Blood Glucose Monitoring System performed as intended and met the system specifications," but it doesn't give specific numerical acceptance criteria (e.g., % of results within ±X mg/dL of reference) or the precise performance values achieved against those criteria. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood glucose monitoring systems, the "ground truth" is typically a laboratory reference method, not an expert panel. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically used for subjective assessments (e.g., image interpretation), not for quantitative measurements like blood glucose. -
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
This information is not applicable and not provided. MRMC studies are related to interpretive tasks often involving medical imaging, not blood glucose meters where the device provides a direct numerical reading. There is no "AI assistance" for human readers in this context. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself (Blood Glucose Monitoring System) is a standalone measurement tool. The document states, "Clinical trials and bench testing showed that the Contour Next One Blood Glucose Monitoring System performed as intended and met the system specifications." This implies standalone performance was evaluated, but details of the study are not provided. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for accuracy studies. For blood glucose meters, the standard ground truth is typically a validated laboratory reference method (e.g., YSI analyzer) measuring plasma glucose. -
The sample size for the training set
This information is not provided in the document. While the document mentions the algorithm was "enhanced for even better accuracy," it does not discuss training sets or how the algorithm was developed in detail. -
How the ground truth for the training set was established
This information is not provided in the document.
§ 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.