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510(k) Data Aggregation
(30 days)
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The FreeStyle InsuLinx 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 to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
The FreeStyle InsuLinx Meter, in conjunction with the FreeStyle InsuLinx Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.
The device automatically logs blood glucose results to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.
Users can pre-program audible and visual reminders for blood glucose testing, or other individual needs.
The FreeStyle InsuLinx System has 'plug and play' software that automatically installs on a computer without the need for a CD or internet access (via the meter's USB port and a provided cable). It also provides access to the structured reports for both the healthcare professionals and patients.
The provided document is a 510(k) premarket notification for the FreeStyle InsuLinx Blood Glucose Monitoring System, detailing its substantial equivalence to a predicate device. This submission primarily focuses on a modification to include a different lancing device and a change in the recommended cleaning and disinfection wipes. While it outlines the acceptance criteria for accuracy and precision, it does not include a detailed study proving the device meets these criteria in the traditional sense of a clinical trial report with specific patient data, expert ground truth establishment, or statistical analyses like MRMC studies.
Instead, the document asserts substantial equivalence based on the device's fundamental technology, indications for use, and performance characteristics (accuracy and precision) being identical to the predicate device (K120568). The only differences noted are related to the lancing device and the disinfectant wipes.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (as per predicate device) | Reported Device Performance (as per predicate device, asserted to be same for modified device) |
|---|---|---|
| Precision | At glucose levels below 75 mg/dL, average SD is ≤ 5 mg/dL. At glucose levels ≥ 75 mg/dL, average CV is ≤ 5%. | Same |
| Accuracy | 95% of results should fall within ± 15 mg/dL of the comparative method results at glucose concentrations < 75 mg/dL and within ± 20% at glucose concentrations ≥ 75 mg/dL. | Same |
| Measurement Glucose Range | 20 to 500 mg/dL | Same |
| Sample Volume | 0.3 µL | Same |
| Measurement Time | Average 5 seconds | Same |
| Hematocrit Range | 15% - 65% | Same |
| Meter Operating Temperature | 40°F to 104°F (4°C to 40°C) | Same |
| Meter Operating Humidity | 5 to 90% Relative Humidity, Non-Condensing | Same |
| Storage Operating Temperature | -4°F to 140°F (-20°C to +60°C) | Same |
| Meter Operating Pressure (Altitude) | Up to 10,000 feet (3048 meters) | Same |
| Double Application (Time for additional blood) | 60 seconds | Same |
| Coding | No coding required | Same |
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 for the K152328 submission does not provide details on the sample size for any test set or the provenance of data. It asserts that the modified device is substantially equivalent to the predicate (K120568), implying that the performance data from the predicate device is applicable. To find this information, one would need to review the K120568 submission details, which are not included in the provided text.
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 document does not contain any information about experts or their qualifications used to establish ground truth. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the way it might be for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This document does not specify any adjudication method. This methodology is generally not applicable to quantitative measurements like blood glucose, where comparison is made against a scientific reference standard.
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
No MRMC study was done or is applicable to this type of device. This device is a blood glucose monitoring system, which provides a direct quantitative measurement and does not involve human interpretation of complex data (like medical images) that would benefit from AI assistance or warrant an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is fundamentally a standalone device in terms of its glucose measurement function. The "algorithm" (coulometric biosensor technology) performs the measurement independently. There isn't a "human-in-the-loop" for the measurement itself, though a human uses the device and interprets the result. The document doesn't explicitly describe a "standalone study" in the context of advanced AI algorithms, but the core functionality is algorithm-driven by the meter and test strip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated in this document, for blood glucose monitoring systems, the ground truth is typically established against laboratory reference methods (e.g., YSI analyzer). The document mentions "comparative method results" in the accuracy section, which refers to these lab-based reference standards.
8. The sample size for the training set
The document does not provide any information regarding a training set sample size. This type of information is usually relevant for machine learning or AI models. The FreeStyle InsuLinx Blood Glucose Monitoring System is based on established electrochemical biosensor technology, which does not typically involve a "training set" in the same way modern AI systems do. Its performance is based on the robust chemical and electrical properties of the test strip and meter.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth would have been established. For the performance validation of the underlying biosensor technology, ground truth would have been established by laboratory reference methods for the predicate device.
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