(393 days)
The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only.
CONTOUR® test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.
The CONTOUR® LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps through use of radio frequency communication.
The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR LINK Wireless Blood Glucose Monitoring System features the CONTOUR LINK Wireless Blood Glucose Monitor and the currently marketed CONTOUR Blood Glucose Test Strips, among other components (e.g., lancing device, lancets and control solution)
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | ||
| Repeatability | Cpk values > 1.0 when compared to established accuracy requirements of ± 20% or ± 15mg/dL. (Internal acceptance criteria; no ISO criteria stated). | Cpk values are greater than 1.0 when compared to established accuracy requirements of ± 20% or ± 15mg/dL. (Mean, SD, and %CV provided for 5 glucose levels, e.g., 41.8 mg/dL with 3.02% CV, 125.7 mg/dL with 2.12% CV, 312.3 mg/dL with 1.60% CV). |
| Intermediate Precision | Cp value for 10 days > 1.0 when compared to established limits of + 11% or +5mg/dL. | Cp values are over 1.0 when compared to established limits of + 11% or + 5mg/dL. (Mean, SD, and %CV provided for Low, Normal, and High control levels, e.g., Low: 38.9 mg/dL with 1.41% CV, Normal: 121.7 mg/dL with 1.04% CV, High: 354.9 mg/dL with 1.26% CV). |
| Accuracy | A minimum of 95% of individual glucose results shall fall within ± 15 mg/dL of the results obtained on the YSI analyzer at glucose concentrations 20 mg/dL): Passed (≤10%). Acetaminophen (>22 mg/dL): Passed (≤10%). Uric Acid (>18 mg/dL): Passed (≤10%). Ascorbic Acid (>30 mg/dL): Passed (≤10%). Maltose (>200 mg/dL): Passed (≤7%). Galactose (>200 mg/dL): Passed (≤7%). Xylose: Interferes with test. | |
| Comparative Performance (New vs. Predicate device) | A proportionally weighted Deming regression of the CONTOUR sensor data: slope and 95% confidence interval around it shall include a 1.0; intercept and 95% confidence interval around it shall include 0.0. Bias of CONTOUR LINK system is not significantly larger (α=0.05) than predicate; 95% CI width for % difference within ±4% (±3 mg/dL if glucose 1.33. | Linearity/assay reportable range: Slope: 0.989 (95% CI 0.989 to 1.008); Intercept: 0.49 (95% CI -0.4 to 1.38 mg/dL). Meets acceptance criteria. |
| Comparison Study (new vs predicate meters): Bias of the CONTOUR LINK system is not significantly larger than the predicate CONTOUR system. System performance meets acceptance criteria. | ||
| Usability/Self-testing Performance | Probability exceeds 95% that a randomly selected person will successfully perform any of the tasks required for successful execution of the blood glucose testing procedure. | Statistical analysis indicates probability exceeds 95% that a randomly selected person will successfully perform any of the tasks required. 99% of subjects either needed no assistance or assistance comparable to a Customer Service call. |
2. Sample Sizes Used for the Test Set(s) and Data Provenance
- Repeatability Test: 10 meters, 10 replicates per meter. Total n=100.
- Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
- Intermediate Precision Test: 10 meters tested over 10 days, one measurement per meter per lot per control solution per day.
- Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
- System Accuracy Evaluation (ISO 15197): 100 fresh capillary blood samples tested using 2 test strip lots on 2 CONTOUR LINK meters. Total of 400 readings.
- Data Provenance: Fresh capillary blood samples (prospective). Country of origin not specified, but typically conducted in the submitting company's R&D facilities or contracted labs.
- Linearity/Assay Reportable Range (Predicate K062058 data cited):
- Study 1: Blood with 40% hematocrit, 5 glucose concentrations, 3 CONTOUR lots, 24 sensors per lot.
- Study 2: 8 meters, 3 sensors per lot tested on each.
- Data Provenance: Unspecified, but derived from the predicate device's 510(k) submission (K062058), so likely both in-house lab testing (prospective) and potentially some clinical data.
- Detection Limit: 3 production lots of CONTOUR sensors, 24 sensors per sample for manipulated blood samples.
- Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
- Analytical Specificity (Interferences): Not explicitly stated how many samples or replicates were performed for each compound.
- Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
- Method Comparison with Predicate Device (Linearity/Assay Reportable Range comparison): 444 paired readings collected.
- Data Provenance: Fresh venous blood; likely prospective in-house lab testing.
- Method Comparison with Predicate Device (CONTOUR LINK vs. CONTOUR meters): 111 subjects (fingerstick study). Two lots of CONTOUR sensors, four CONTOUR meters. RF function of CONTOUR LINK left on.
- Data Provenance: Fresh capillary blood samples from 111 subjects. Likely prospective clinical or usability study. Country unspecified.
- Clinical Study (Usability and Accuracy - New Device): 77 adults.
- Data Provenance: Adults aged 20-85 (fresh capillary blood, self-test and HCP-test results). Likely prospective clinical or usability study. Country unspecified.
- Clinical Study (Usability and Accuracy - Predicate K062058 cited): 109 adults.
- Data Provenance: Adults aged 20-75 (self-testing). Derived from predicate device's 510(k) submission (K062058). Likely prospective clinical or usability study. Country unspecified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No human experts were used for establishing ground truth. The ground truth in these studies was established using a high-precision laboratory reference method.
4. Adjudication Method for the Test Set
- Not applicable. Since the ground truth was established by a laboratory reference instrument (YSI 2300 STAT PLUS glucose analyzer) rather than human experts, there was no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done in the context of comparing human readers (interpreting images/cases) with and without AI assistance. This device is a blood glucose meter, and its performance is assessed against a laboratory reference standard, not against human interpretation of images.
- A comparative performance study was done between the new device (CONTOUR LINK) and the predicate device (CONTOUR) using blood samples, showing equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, the device's accuracy tests (Precision, System Accuracy, Linearity, Detection Limit, Analytical Specificity) represent standalone performance, as these evaluate the device's ability to measure glucose values compared to a reference method, without human intervention in the measurement process itself beyond standard operation. The clinical study also included "HCP-test results" which implies professional use, which would also be standalone.
- The clinical usability studies involved human users (self-testers and HCPs) operating the device, but the accuracy assessment within these studies is still primarily evaluating the device's standalone measurement capability under real-world usage conditions.
7. The Type of Ground Truth Used
- Laboratory Reference Method: The primary and most frequently cited ground truth was the YSI 2300 STAT PLUS glucose analyzer.
- Traceability: The YSI analyzer is traceable to the hexokinase method, which was developed collaboratively by the FDA, CDC, NIST, and AACC. This method utilizes NIST Standard Reference Material 917, dry D-glucose.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size for a training set. Blood glucose meters typically do not involve "training sets" in the same way AI algorithms do unless specific machine learning components are involved (which is not described here). The development and calibration of such devices usually rely on extensive internal R&D test data and validated chemical/electrical principles, rather than a publicly reported "training set."
9. How the Ground Truth for the Training Set Was Established
- As the document does not explicitly mention a training set in the context of an AI/ML model, it also does not describe how ground truth for such a set was established. Device calibration and internal validation would rely on the same laboratory reference methods described for the performance studies (e.g., YSI 2300 STAT PLUS traceable to hexokinase method).
§ 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.