(318 days)
The On Call Sharp Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call Sharp Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call Sharp Blood Glucose Monitoring System in not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.
The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm."
The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
For In Vitro Diagnostic Use
The On Call Sharp Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The provided text describes the "On Call Sharp Blood Glucose Monitoring System" and its performance evaluation. Here's a summary of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The submission mentions compliance with EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus." This standard typically sets the accuracy requirements for blood glucose monitoring systems. While the exact numerical criteria from ISO 15197 are not explicitly stated in the provided text, the conclusion affirms that the device "meets the accuracy requirements per EN ISO 15197."
Based on the information provided, a table detailing specific acceptance criteria and reported device performance from the clinical study, particularly regarding accuracy, would typically present comparisons between device readings and a reference method (like YSI Model 2300 STAT PLUS). However, the document only broadly states that the device "meets the accuracy requirements per EN ISO 15197."
General Features and Specifications (as acceptance criteria for technical characteristics):
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (as per specification) |
|---|---|---|
| Measurement Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) | 20 to 600 mg/dL (1.1-33.3 mmol/L) |
| Result Calibration | Plasma-equivalent | Plasma-equivalent |
| Sample | Fresh capillary whole blood | Fresh capillary whole blood |
| Minimum Sample Size | 0.8 µL | 0.8 µL |
| Test Time | 5 seconds | 5 seconds |
| Battery Life | Minimum of 1,000 measurements | Minimum of 1,000 measurements |
| Hematocrit Range | 25-70% | 25-70% |
| Operating Temperature | 10-45°C (50-113°F) | 10-45°C (50-113°F) |
| Operating Relative Humidity | 10-90% (non-condensing) | 10-90% (non-condensing) |
| Coding | Auto Coding by meter automatic recognition | Auto Coding by meter automatic recognition |
| Meter Memory | Up to 500 records with time and date | Up to 500 records with time and date |
| User Satisfaction | Users satisfied with ease of operation and overall performance | Acknowledged via lay person questionnaire |
The specific accuracy data (e.g., mean bias, percentage of readings within certain error margins) required by ISO 15197 is not detailed in this summary. The summary only concludes that the device meets these requirements.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact numerical sample size (number of participants or measurements) used in the clinical studies for the test set. It mentions studies were conducted with "lay persons and trained laboratory technicians."
- Data Provenance: The document does not explicitly state the country of origin. It indicates that the studies were performed using the ACON Clinical Study Protocol for the Blood Glucose Monitoring System, implying an internal or sponsored study. The clinical studies were performed to evaluate system accuracy compared to a reference method. It's a prospective study as it involves conducting clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: The document mentions "trained laboratory technicians" performed comparative readings. It does not specify the number of technicians involved.
- Qualifications of Experts: The experts are described as "trained laboratory technicians." Specific qualifications (e.g., years of experience, certifications) are not provided.
4. Adjudication method for the test set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "trained laboratory technicians" used the YSI Model 2300 STAT PLUS as a reference method. The comparison was between the device readings by lay persons and the results obtained by these technicians using the reference device.
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
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor is there any mention of AI assistance. This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system for measuring blood glucose. The performance evaluation includes both its internal accuracy (laboratory testing) and its use by "lay persons" (human-in-the-loop). The "algorithm only" performance would be equivalent to the device's accuracy when operated correctly, which is implied by the laboratory testing and comparison to the YSI reference. The clinical study also involved assessing accuracy when used by lay persons, which is a key aspect of real-world "human-in-the-loop" performance for a self-monitoring device.
7. The type of ground truth used
The ground truth for the accuracy evaluation was established using a reference method, specifically the YSI Model 2300 STAT PLUS (K913806), which is a laboratory-grade analyzer for glucose measurement.
8. The sample size for the training set
The document does not provide information about a separate "training set" or its sample size. For medical devices like this, performance is typically evaluated against established standards and reference methods in validation studies, rather than a machine learning training/test set paradigm.
9. How the ground truth for the training set was established
As no specific "training set" for a machine learning algorithm is mentioned, information on how its ground truth was established is not applicable or provided. The device relies on established electrochemical principles and calibration against reference methods.
§ 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.