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510(k) Data Aggregation
(230 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.
FreeStyle Control Solutions are for use with the FreeStyle InsuLinx Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
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 and other events to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.
Patient and Healthcare Professionals can pre-program audible and visual reminders for blood glucose testing, or other individual needs.
Weekly messages feature assist the patient in identifying patterns in their blood glucose results. Using a rolling report, the measured glucose values are summarized according to the proportion within, above, or below the predetermined target range entered by the patient or HCP. These results are displayed in a simple graphical format and include a count of the tests performed. An additional algorithm compares the prevailing blood glucose levels during the preceding week with simple messages relating to achievement versus target glucose levels.
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 FreeStyle Auto-Assist software produces six different reports to facilitate discussion between patients and their health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program. The software also shows trends in blood glucose data in both graphical and text format for guided interpretation.
- The Snapshot Report is a general summary of the data for a specified date range.
- The Modal Day Report shows the daily patterns of blood glucose levels over a specified date range
- The Logbook Report is a table of blood glucose for each day in the specified date range.
- The Daily Statistics Report provides an overview of blood glucose over the date range in a series of charts and tables.
- The Meal Event Averages Report compares the before and after meal blood glucose level averages for the morning, mid-day and evening times over the specified date range.
- The Meter Settings Report shows current meter settings.
These reports provide detailed information on glucose monitoring, and are designed to enable healthcare professionals and patients to assess the effectiveness of diabetes management and then plan appropriate changes to therapy regimens.
The FreeStyle InsuLinx System may be packaged within a cardboard carton, in addition to the following components and accessories listed below.
- (A) FreeStyle InsuLinx Meter
- (B) 10 count vial of FreeStyle InsuLinx Test Strips (may be sold separately)
- (C) FreeStyle Auto-Assist software (resides in the FreeStyle InsuLinx Meter)
- (D) Carrying Case
- (E) Owner's Booklet
- (F) Quick Start Guide
- (G) USB Cable
- (H) FreeStyle Control Solutions (may be obtained by contacting Customer Service)
The provided text describes the FreeStyle InsuLinx Blood Glucose Monitoring System and compares it to a predicate device, but it does not contain a dedicated section detailing acceptance criteria or a specific study proving the device meets those criteria, nor does it provide the requested sample sizes, expert qualifications, or ground truth establishment methods in a comprehensive manner.
However, based on the "Comparison to Predicate Device" table, we can infer the acceptance criteria for certain performance characteristics and the device's reported performance against those metrics, as they are presented as equivalent to a previously cleared device.
Here's an attempt to extract the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the performance characteristics of the predicate device, which the FreeStyle InsuLinx Blood Glucose Monitoring System claims to be substantially equivalent to.
| Performance Characteristic | Acceptance Criteria (inferred from predicate) | Reported Device Performance (FreeStyle InsuLinx) |
|---|---|---|
| Precision | At glucose levels below 75mg/dL average SD is ≤ 5mg/dL and at glucose levels ≥ 75mg/dL average CV is ≤ 5% | At glucose levels below 75mg/dL average SD is ≤ 5mg/dL and at glucose levels ≥ 75mg/dL average CV is ≤ 5% |
| Accuracy | 95% of results should fall within ± 15mg/dL of the comparative method results at glucose concentrations < 75mg/dL and within ±20% at glucose concentrations ≥ 75mg/dL | 95% of results should fall within ± 15mg/dL of the comparative method results at glucose concentrations < 75mg/dL and within ±20% at glucose concentrations ≥ 75mg/dL |
| Sample Volume | 0.3 µL | 0.3 µL |
| Measurement Glucose Range | 20 to 500 mg/dL | 20 to 500 mg/dL |
| Meter Operating Humidity | 5 to 90% Relative Humidity, Non-Condensing | 5 to 90% Relative Humidity, Non-Condensing |
| Storage Operating Temperature | -4°F to 140°F (-20°C to +60°C) | -4°F to 140°F (-20°C to +60°C) |
| Double Application (Time for) | 60 seconds | 60 seconds |
| Measurement Time | average of 15 seconds (predicate) | average 5 seconds (FreeStyle InsuLinx) |
Note: The document explicitly states "The similarities between FreeStyle InsuLinx System and the predicate are highlighted below," and then lists the exact same values for Precision and Accuracy for both devices. This indicates that the FreeStyle InsuLinx system is expected to meet these values, implying they are the acceptance criteria, and it reports meeting them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mainly focuses on device description and comparison to a predicate, not detailed study methodologies or data specifics.
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 provided in the document. The ground truth for blood glucose monitoring systems is typically established by laboratory reference methods, not expert consensus in the same way it would be for imaging diagnostics. The document only mentions "comparative method results" in the accuracy section, implying a laboratory reference standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for studies where human interpretation is involved. For a blood glucose meter, the "ground truth" is typically a quantitative laboratory measurement, not subject to human adjudication in the same way.
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 comparative effectiveness study is not mentioned and is not applicable to this type of device (blood glucose monitoring system). This type of study is relevant for imaging diagnostics where human readers interpret patient data. The FreeStyle InsuLinx system is a standalone diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance characteristics described for Precision and Accuracy are for the standalone device (algorithm only). The "comparative method results" used as ground truth indicate that the device's measurements are being compared directly to a reference standard performed in a laboratory setting, without human interpretation as part of the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used appears to be a laboratory comparative method for glucose measurement. The accuracy statement refers to "comparative method results," which in the context of blood glucose monitoring typically means a highly accurate laboratory analyzer.
8. The sample size for the training set
This information is not provided in the document. For a medical device like a blood glucose meter, the "training set" would refer to the data used during the development and calibration of the electrochemical biosensor and its algorithms. This is usually proprietary and not detailed in 510(k) summaries to this extent.
9. How the ground truth for the training set was established
This information is not provided in the document. Similar to point 8, the establishment of ground truth for the training/calibration phase would involve established laboratory reference methods, but the specific details are not disclosed here.
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