(122 days)
The CareSens N Voice Multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm. palm, thigh, and calf. Alternative site. testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in virro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N Voice Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The meter has a speaking function but it is not intended for use by the visually impaired persons.
The CareSens N Voice Multi Blood Glucose Monitoring System (BGMS) consists of a multi use blood glucose meter, test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately).
The CareSens N Voice Multi BGMS are based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.
The provided document pertains to a 510(k) submission for the "CareSens N Voice Multi Blood Glucose Monitoring System". This is a regulatory submission for a medical device that measures blood glucose, and the criteria and studies described are for demonstrating substantial equivalence to a predicate device, as opposed to a new AI model with clinical performance studies.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC study, standalone performance, training set) typically applies to more complex AI/ML device submissions, especially those involving image analysis or diagnostic support where a 'ground truth' needs to be established by experts.
For this blood glucose monitoring system, the "performance" is typically assessed through analytical studies demonstrating accuracy against a reference method, rather than through expert adjudication or large scale clinical outcome studies as one might find for an AI diagnostic tool.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document mentions that "the candidate device has met the performance, safety, and effectiveness of the device for its intended use." However, it does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy metrics or ranges) for blood glucose measurement. It also doesn't present a table of reported device performance values against such criteria. The submission focuses more on the equivalence to the predicate device and the disinfection study.
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 does not specify the sample size used for any performance testing of the blood glucose measurement function, nor does it provide details on data provenance (country, retrospective/prospective). The only study detailed is a disinfection study.
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):
This information is not applicable to a blood glucose monitoring system in the same way it would be for an AI diagnostic imaging device. Blood glucose measurements are typically compared against a laboratory reference method (e.g., YSI analyzer) rather than expert consensus. The document does not mention any expert involvement in establishing 'ground truth' for glucose measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for a blood glucose monitoring system; no adjudication method would be used for this type of device performance evaluation.
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. This device is a standalone blood glucose meter and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is inherently "standalone" in its function as a blood glucose meter, as it directly measures glucose levels. The document states it is "intended for use outside the body (in vitro)" and "measures the glucose level in whole blood samples." This confirms it operates independently to provide the measurement.
7. 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 performance evaluation of blood glucose measurement. However, for blood glucose meters, the "ground truth" (or reference standard) is almost universally a highly accurate laboratory method, such as a YSI glucose analyzer.
8. The sample size for the training set:
The concept of a "training set" is typically associated with machine learning or AI models. This device is an electrochemical biosensor, not an AI model, so there isn't a "training set" in that sense.
9. How the ground truth for the training set was established:
Not applicable due to the reasons stated in point 8.
§ 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.