(69 days)
The Contour USB Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Contour USB is an over the counter (OTC) device utilized by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Contour USB Diabetes Care System is indicated for use with capillary, venous and arterial whole blood samples. Capillary samples may be drawn from fingertip, palm and forearm. The Contour USB is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
GLUCOFACTS® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by Health Care Professionals and Patients with Diabetes for viewing and printing reports that display blood sugar readings from Bayer's CONTOUR® and BREEZE® families of meters.
Contour USB Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System
This FDA 510(k) clearance letter for the Contour USB Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System (K091820) primarily focuses on establishing substantial equivalence to a predicate device. It does not contain the detailed information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.
The document confirms the device's legality for marketing and mentions its intended use for measuring glucose in whole blood for individuals with diabetes and healthcare professionals. However, it does not provide any specific performance data, study results, acceptance criteria, sample sizes, ground truth establishment, or expert involvement details.
To provide a comprehensive answer, I would need access to the actual 510(k) submission (which often includes performance data and studies) or other publicly available documentation from the manufacturer or FDA related to this specific device.
Based only on the provided document, here's what can be inferred or explicitly stated, with significant limitations:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided document. The document is a clearance letter, not a performance report. Performance data and acceptance criteria would be part of the original 510(k) submission, not typically summarized in the clearance letter itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided document.
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)
- Not available in the provided document. For a blood glucose meter, the "ground truth" is typically established by laboratory reference methods, not necessarily by expert consensus in the same way as imaging interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available in the provided document. Adjudication methods like 2+1 or 3+1 are common in image interpretation studies where experts disagree. For quantitative measurements like blood glucose, agreement is typically assessed against a reference method rather than through expert adjudication of results.
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
- Not applicable/Not available in the provided document. MRMC studies are relevant for diagnostic imaging interpretation where human readers interpret cases. This device is a blood glucose meter, where the user reads a numerical output, not a complex image. The "AI" component mentioned (Glucofacts Delux software) is for viewing and printing reports, not for performing interpretative diagnostics and thus an MRMC study in the traditional sense wouldn't apply to the meter's performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly for the blood glucose meter itself. The Contour USB Blood Glucose Meter is expected to operate as a standalone device, providing a numerical glucose reading without human interpretation of raw signals. Its performance would be assessed standalone against a reference method. The document, however, does not provide performance data.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Likely a laboratory reference method. For blood glucose meters, the ground truth is almost universally established by comparing the device's readings to laboratory-based reference methods (e.g., YSI glucose analyzer) on the same blood samples. This is a highly accurate chemical analysis, not expert consensus or pathology in the typical sense.
- Not explicitly stated in the provided document.
8. The sample size for the training set
- Not applicable/Not available in the provided document. For a traditional medical device like a blood glucose meter, the "training set" concept (as used for machine learning models) does not directly apply. The device is calibrated and validated, but it doesn't "learn" from a training set in the same way an AI algorithm does.
9. How the ground truth for the training set was established
- Not applicable/Not available in the provided document. (See point 8)
In summary, the provided FDA clearance letter is insufficient to extract the detailed study and acceptance criteria information you are requesting. Answering these questions fully would require accessing the original 510(k) submission 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.