(745 days)
The Contour® next GEN Blood Glucose Monitoring System contour® next GEN meter, Contour® next 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 test strips and Contour® next control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the Contour® next ONE blood glucose meter. It uses two replaceable CR2032 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 document provides information on the Contour® next GEN Blood Glucose Monitoring System, a medical device for quantitative measurement of glucose in fresh capillary whole blood. The device has been reviewed by the FDA and determined to be substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text, addressing your specific questions about acceptance criteria and the study proving the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria for glucose measurement accuracy with specific numerical targets (e.g., % of readings within +/- X mg/dL or %). However, it states that "Clinical trials and bench testing showed that the Contour® next GEN Blood Glucose Monitoring System performed as intended and met the system specifications."
For glucose meters, the generally accepted accuracy standards are often based on ISO 15197 (or similar national standards). The FDA might have specific internal or guidance-based acceptance criteria for substantial equivalence claims. Given the context of a 510(k) submission, the device is being compared to a predicate, implying that its performance is equivalent to, or better than, the predicate device which presumably met relevant accuracy standards at its time of clearance.
Without direct quantitative performance data in this specific document, a table cannot be fully constructed. However, the qualitative "reported device performance" is that it "performed as intended and met the system specifications."
| Acceptance Criteria (Implied from Standard Practice for BGM Systems) | Reported Device Performance |
|---|---|
| Accuracy (e.g., ISO 15197 standard for glucose measurement) | Met system specifications and performed as intended. |
| Usability | Easy to use by typical customers. |
| Safety and Effectiveness | Substantially equivalent to predicate, implying safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Clinical trials and bench testing" and "Usability testing" but does not specify the sample sizes used for these test sets.
Similarly, data provenance (country of origin, retrospective or prospective) is not detailed in this summary. These details would typically be found in the full submission, which is not provided here.
3. 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)
For a blood glucose monitoring system, the "ground truth" for glucose concentration is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than expert radiographic review. The document does not specify details about the personnel or their qualifications involved in establishing this reference ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically for human reader studies involving subjective interpretations (e.g., radiology). For a blood glucose meter, the "ground truth" is a quantitative measurement from a reference laboratory instrument, which doesn't involve human interpretation directly or require adjudication in the same way. Therefore, this concept is not applicable in the context of a glucose meter's accuracy testing, and no adjudication method is mentioned.
5. 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
An MRMC study is relevant for AI-assisted diagnostic imaging, where human readers interpret cases with or without AI assistance. This is not applicable to a blood glucose monitoring system, which provides a direct numerical measurement and is used by individuals for self-monitoring. The device itself is not an AI system assisting human interpretation of images. Consequently, no MRMC study or effect size for human reader improvement is mentioned or expected.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
For a blood glucose meter, the "standalone performance" is essentially the device's accuracy in measuring glucose values against a reference method. The document states that "Clinical trials and bench testing showed that the Contour® next GEN Blood Glucose Monitoring System performed as intended and met the system specifications." This implies that the device's ability to measure glucose values accurately was assessed, which is its standalone performance. The system's algorithm (mentioned as "similar algorithm as the one used in the Contour® next ONE blood glucose meter" and having "Modified terms in the equations") is intrinsic to its measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a blood glucose monitoring system is established by highly accurate laboratory reference methods for glucose measurement, typically performed on venous blood samples. These reference methods are considered the gold standard for quantifying glucose concentration. The document does not explicitly state "laboratory reference method" but this is the standard practice for such devices.
8. The sample size for the training set
The document does not provide information on the sample size for the training set. Blood glucose meters typically use algorithms (the document mentions "similar algorithm as the one used in the Contour® next ONE" and "Modified terms in the equations"), which might be developed using extensive calibration data. Details about this data (size, characteristics) are not available in this summary.
9. How the ground truth for the training set was established
Similar to the test set, the ground truth for any data used in training/calibration of the glucose meter's algorithm would have been established by highly accurate laboratory reference methods for glucose measurement. The document does not provide specifics on how this was established for the training data.
§ 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.