(23 days)
The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next blood glucose test strips and the Contour® Diabetes app.
The Contour® next GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN 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 GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The system is intended for in vitro diagnostic use only.
CONTOUR® NEXT GEN Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution. The meter can be connected to the CONTOUR® Diabetes app. It uses two replaceable CR2032 or DL2032 coin cell batteries. The meter's shape is a traditional oval form factor, and it includes an illuminated strip port with colors indicating if a glucose result is above, within, or below target.
The provided text describes a 510(k) summary for the CONTOUR® next GEN Blood Glucose Monitoring System. This submission focuses on demonstrating substantial equivalence to a predicate device due to minor modifications (e.g., changes to internal meter circuitry due to component end-of-life, changes to packaging, user guide format, and test strip packaging from bottled to foil-packed).
The information provided is typical for a 510(k) submission of a blood glucose monitoring system, which primarily relies on analytical performance data (accuracy of glucose measurements) to demonstrate that the device performs as intended and is substantially equivalent to a predicate. This type of device does not involve an AI algorithm with a training or test set, nor does it involve expert reviews, ground truth establishment through consensus, or MRMC studies.
Therefore, the requested information regarding AI acceptance criteria and study details (sample sizes for training/test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this specific device submission. The device described is a physical medical device (blood glucose meter and test strips), not an AI-powered diagnostic system.
However, I can extract information related to the performance testing mentioned, even if it's not structured around AI-specific criteria.
Key takeaway: This document does not describe an AI medical device.
Information applicable to the device (even without AI context):
-
A table of acceptance criteria and the reported device performance:
The document states: "Verification testing against well-established methods showed that the modified CONTOUR® NEXT GEN Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications."
It also mentions: "Validation testing with the proposed black and white pamphlet User Guide demonstrated that the CONTOUR® NEXT GEN Blood Glucose Monitoring System continued to be easy to use by typical customers."
However, the specific numerical acceptance criteria and reported performance data are not detailed in this 510(k) summary. For a blood glucose meter, this would typically involve accuracy metrics (e.g., % of results within ±X% of reference, ISO 15197 compliance). This summary only states that they were met. -
Sample sizes used for the test set and the data provenance:
Not explicitly stated in the provided text. For a blood glucose meter, validation studies would involve a sufficient number of blood samples (from various glucose concentrations) and potentially human subject testing for usability/accuracy. The provenance would likely be from clinical sites where these tests were performed. -
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):
Not applicable, as this is not an AI diagnostic device. Ground truth for blood glucose meters is established by reference laboratory methods (e.g., YSI or hexokinase method) on the same blood samples. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. -
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:
Not applicable, as this is not an AI diagnostic device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI algorithm. The device itself is the "standalone" entity that performs the glucose measurement. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a blood glucose monitoring system, the ground truth for glucose levels is established using a highly accurate and precise laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or a hexokinase enzymatic method). -
The sample size for the training set:
Not applicable, as this is not an AI device with a training set. -
How the ground truth for the training set was established:
Not applicable, as this is not an AI device.
In summary, the provided document is a 510(k) premarket notification for a blood glucose monitoring system, which is a physical diagnostic device. It does not contain information about AI algorithm development, training, or testing, and therefore, most of the requested details are not relevant to this specific submission.
§ 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.