(35 days)
The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.
The FreeStyle Connect monitor utilizes coulometric biosensor technology found in the FreeStyle Connect test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Connect BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.
The provided text describes a 510(k) summary for the FreeStyle Connect™ Blood Glucose Monitoring System. The information is limited to establishing substantial equivalence to a predicate device and does not detail specific acceptance criteria or an in-depth study proving the device meets said criteria with specific performance metrics beyond a statement of "acceptability and comparability."
Therefore, based only on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. It broadly states: "The results obtained during these studies demonstrated that the FreeStyle Connect BGMS is substantially equivalent to the predicate devices." and "Results of laboratory testing demonstrated that the performance of the FreeStyle Connect BGMS is acceptable and comparable to the performance of the predicate devices for blood glucose testing when used according to its intended use."
Without specific numerical cutoffs for accuracy, precision, or other performance characteristics, a table cannot be fully constructed.
2. Sample sized used for the test set and the data provenance:
The document mentions "laboratory testing" and "performance studies" but does not specify the sample size used for the test set, nor does it provide the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide any information regarding experts used to establish ground truth or their qualifications. Blood glucose monitoring systems typically use a reference method for ground truth, such as a laboratory analyzer, rather than expert consensus on images.
4. Adjudication method for the test set:
The document does not mention any adjudication method for the test set. Given the nature of a blood glucose monitoring system, adjudication in the sense of reconciling reviewer disagreements on, for example, image interpretation, would not be applicable.
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:
This question is not applicable to a blood glucose monitoring system. MRMC studies and AI assistance for human readers are relevant to imaging diagnostics or other fields where human interpretation is a primary component of diagnosis, not for automated quantitative measurements from a device like a blood glucose meter. The FreeStyle Connect BGMS is an in vitro diagnostic device that provides a quantitative measurement of glucose.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The FreeStyle Connect Blood Glucose Monitoring System is inherently a standalone device in its core function. It measures glucose electrochemically based on biosensor technology. Its performance, as described, would be "algorithm only without human-in-the-loop performance" in terms of generating the glucose value. The "performance studies" mentioned would reflect this standalone performance.
7. The type of ground truth used:
While not explicitly stated, for a blood glucose monitoring system, the ground truth for performance studies is typically established by a reference laboratory method or a highly accurate laboratory analyzer (e.g., YSI analyzer) that provides a validated glucose concentration. The document states it measures "glucose concentration in whole blood samples," implying comparison against a gold standard for blood glucose measurement. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
The document does not specify any sample size for a training set. For a device utilizing biosensor technology and electrochemical measurement as described, "training set" in the context of machine learning is not directly applicable in the same way as it would be for an AI-powered image analysis system. The development would involve calibration and validation based on chemical and electrical principles rather than iterative training on large datasets in the AI sense.
9. How the ground truth for the training set was established:
As above, the concept of a "training set" in the AI sense is unlikely to apply directly to this device. If there were any development data (akin to training), the ground truth would similarly be established using reference laboratory methods/analyzers for glucose concentration.
§ 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.