(335 days)
The Okmeter Match Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions. The meter has some audible features but it is not for use by the visually impaired.
The Okmeter Test Surins are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Okmeter Test Strips must be used with the Okmeter Match Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are 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. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The Okmeter 2 levels (Normal and High) Control Solution are for use with the Okmeter Match Blood Glucose Monitoring System and Okmeter Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Match Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds. The device including two test strips there are identical in structure design and test performance, the only difference in colors (White for strip A and Green for strip B).
The provided text lacks specific details about acceptance criteria and the results of a study proving the device meets those criteria. However, I can extract the available information and highlight what is missing based on your request.
Here's a breakdown of the available information and what's not present:
Acceptance Criteria and Device Performance:
The document mentions "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/FDA." This implies that the device was tested against FDA guidance, which would contain specific acceptance criteria for accuracy, precision, and other relevant performance metrics for blood glucose monitoring systems. However, the exact acceptance criteria and the reported numerical performance of the Okmeter Match Blood Glucose Monitoring System are not provided in the given text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (e.g., within +/- X% of Y reference) | Not provided in the text | Not provided in the text |
| Precision (e.g., standard deviation) | Not provided in the text | Not provided in the text |
| Measuring Time | 6 seconds (implied as a feature, not a criterion) | 6 seconds |
| Sample Volume | Small amount of blood (implied) | Small amount of blood |
| Detecting Range | Not provided in the text | Not provided in the text |
| HCT Range | Not provided in the text | Not provided in the text |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not provided in the text. The document states "Pre-clinical and clinical data are employed," but it does not specify the number of subjects or samples used in these studies.
- Data Provenance: The manufacturer is OK Biotech Co., Ltd., located in Taiwan, ROC. The studies were likely conducted in Taiwan, but this is not explicitly stated for the clinical data. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Not provided in the text. For a blood glucose monitoring system, the "ground truth" is typically established by laboratory reference methods, not by expert consensus on image interpretation. Therefore, this question may not be directly applicable in the same way it would be for an AI-powered diagnostic imaging device. If expert validation of a reference method was involved, the details are missing.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided in the text. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments (e.g., expert interpretation of medical images). For a quantitative device like a blood glucose meter, the "ground truth" is typically a quantitative measurement from a highly accurate lab instrument, not subject to individual interpretation or adjudication among experts in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- Not applicable/Not provided in the text. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The Okmeter Match Blood Glucose Monitoring System is a standalone device for direct quantitative measurement, not an AI-assisted diagnostic tool that helps human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, by definition. The Okmeter Match Blood Glucose Monitoring System is a standalone device. Its performance, as implied by the "Pre-clinical and clinical data," would represent its standalone accuracy and precision. The reported "6 seconds" for result display is a standalone performance metric.
7. The Type of Ground Truth Used:
- Implied to be laboratory reference methods for glucose measurement. While not explicitly stated, for a blood glucose monitoring system, the ground truth is universally established by a highly accurate, often laboratory-based, glucose analyzer. The document mentions "Pre-clinical and clinical data," which would have involved comparing the device's readings to such a reference method. The text does not mention pathology, outcomes data, or expert consensus in this context.
8. The Sample Size for the Training Set:
- Not applicable/Not provided in the text explicitly as a "training set." Blood glucose meters based on electrochemical biosensor technology generally do not involve AI/machine learning training sets in the same way an image recognition algorithm would. While there is likely internal verification and calibration during development, the document doesn't describe a distinct "training set" with established ground truth as would be relevant for an AI model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided in the text. See the explanation for point 8.
§ 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.