(231 days)
The GLUCOCARD X-METER Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The GLUCOCARD X-METER Blood Glucose Monitoring System consists of a meter, sensor test strips, and control solutions for use as an aid to monitor the effectiveness of diabetes control.
The provided text describes the GLUCOCARD X-METER Blood Glucose Monitoring System. However, it does not contain the specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment that would be needed to fully answer your request.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "Functional and Safety Testing" including "clinical testing included evaluation of accuracy for both finger stick and Alternate Site Testing." However, it does not provide the specific acceptance criteria (e.g., ISO 15197 compliance, specific accuracy percentages at different glucose ranges) nor the actual reported device performance metrics (e.g., bias, precision, percentage of readings within a certain range of a reference method).
2. Sample Size Used for the Test Set and Data Provenance:
The document states "clinical testing included evaluation of accuracy." However, it does not specify the sample size (number of patients or readings) used for the test set, nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data collection).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions "clinical settings by healthcare professionals" as an intended use but does not provide information on how many experts were used to establish the ground truth for the test set, nor their specific qualifications. For glucose meters, the "ground truth" (reference method) is typically a laboratory-based analyzer, not expert consensus on the reading itself.
4. Adjudication Method for the Test Set:
Given that the ground truth for glucose meters is typically a laboratory reference method, an adjudication method for the test set (e.g., 2+1, 3+1) is not applicable in the same way it would be for image-based diagnostic devices. The device reading is compared directly to the reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to a blood glucose meter. This type of study is relevant for diagnostic devices that involve human interpretation of images or other complex data. Blood glucose meters provide a direct numerical output.
6. Standalone Performance Study:
Yes, a standalone performance study was implicitly done. The "clinical testing included evaluation of accuracy" refers to the device's performance in measuring glucose levels. This is a standalone evaluation of the algorithm and device without a human-in-the-loop scenario. The output is a direct glucose reading from the device.
7. Type of Ground Truth Used:
The type of ground truth used would almost certainly be a laboratory reference method (e.g., a YSI STAT PLUS Glucose & L-Lactate Analyzer or similar) for measuring glucose in blood samples. This is standard practice for blood glucose meter accuracy studies. The document does not explicitly state this, but it is the industry standard for this type of device.
8. Sample Size for the Training Set:
The document does not provide any information about a training set size. For a device like a blood glucose meter, the "training set" might refer to the data used during the development and calibration of the electrochemical sensor and algorithm. This information is typically proprietary and not included in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
Similar to the training set size, the document does not provide information on how the ground truth for the training set was established. This would relate to the methods used during the device's development and calibration, likely involving comparisons to laboratory reference methods with known concentrations.
In summary, while the document confirms clinical testing for accuracy was performed, it lacks the detailed quantitative information on acceptance criteria, specific performance metrics, sample sizes, and the exact nature of the ground truth required to fully answer your request. This level of detail is often found in the full 510(k) submission and supporting study reports, which are more extensive than the summary provided.
§ 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.