(208 days)
The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The NoCoding1 Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The VeraSens Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The VeraSens Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The VeraSens Blood Glucose Test Strips are for use with the VeraSens Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The NoCoding1 Plus BGMS and VeraSens BGMS is a derivation from the same design file as its predicate device, NoCoding1 Plus Blood Glucose Monitoring System with the addition of a Bluetooth module. This Premarket Notification (510(k) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device, NoCoding1 Plus Blood Glucose Monitoring System, K160742.
The NoCoding1 Plus BGMS and VeraSens BGMS consist of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges).
The NoCoding1 Plus BGMS and VeraSens BGMS is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.
The provided text describes the i-SENS NoCoding1 Plus Blood Glucose Monitoring System and VeraSens Blood Glucose Monitoring System. The document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full study with acceptance criteria and detailed performance data.
However, I can extract information related to acceptance criteria and device performance based on the type of device and the context provided. The non-clinical section states that "Verification, validation and testing activities were conducted to establish the performance, functionality characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This indicates that acceptance criteria were defined, and the device met them.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data for glucose measurement accuracy. However, it implicitly refers to established "pre-determined Pass/Fail criteria" for verification, validation, and testing activities. Given the device type (blood glucose monitoring system), these criteria would typically refer to accuracy standards like those set by ISO 15197 (e.g., specific percentages of results within +/- certain mg/dL or %). The document does not provide the specific numerical acceptance criteria or the reported device performance in terms of accuracy metrics (e.g., mean absolute relative difference, percentage within limits).
The provided non-clinical summary focuses more on functional aspects related to the addition of a Bluetooth module, cleaning/disinfection, and cybersecurity.
| Acceptance Criteria Category (Implied) | Reported Device Performance (as described) |
|---|---|
| Glucose Measurement Accuracy | "Verification, validation and testing activities were conducted to establish the performance, functionality characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." |
| (Specific numerical accuracy metrics (e.g., % within +/- 15 mg/dL) are not detailed in this summary.) | |
| Cleaning and Disinfection Effectiveness | "Results demonstrated complete inactivation of live virus inoculated on the materials of the meter and lancing device." |
| Durability after Cleaning/Disinfection | "260 each of pre-cleaning and disinfection cycles for meter... has no effect on the performance or the external materials of the meter and lancing device." |
| Cybersecurity (Bluetooth connection to unintended device) | "Passkey entry and short display time of showing Passkey was adopted to prevent that situation and software function test was done to verify this." "Residual risk falls from AFAP to ACC region." |
| Cybersecurity (Data transmission without encryption) | "Product design which meets Bluetooth SIG standard." "Bluetooth SIG certification was received." |
| Cybersecurity (Outside intrusion during UART communication) | "Connect with a device using the protocol designed by i-SENS, Inc." "User Manual pg. 10, 41." "Residual risk falls from AFAP to ACC region." |
| Software Function (Error of download function using UART/Bluetooth) | "Memory Test was done to verify the memory function of the meter and lower the probability of the risk." "Residual risk falls from AFAP to ACC region." |
| Electromagnetic Field Compatibility | "EMC test report, Caution indication (Manual)." "R&TTE and FCC test was done to verify that there is no problem of meter's electromagnetic field effect." "Residual risk falls from AFAP to ACC region." |
| User Errors/Unawareness (Human Factor Study) | "Human Factor Study was done to verify the user convenience of using the meter." "Residual risk still exists, it is not in the non-acceptable region." |
| User Errors/Unawareness (Bluetooth pairing difficulties) | "Use instruction in the user manual." "Residual risk falls from AFAP to ACC region." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not explicitly provided in the summary for the core glucose measurement accuracy testing. For cleaning and disinfection, it states "260 each of pre-cleaning and disinfection cycles."
- Data Provenance: Not specified. The document is from i-SENS, Inc. in Seoul, Korea, which is the manufacturer's location, but this does not confirm the origin of patient data (if any was used for core performance studies).
- Retrospective or Prospective: Not specified.
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. For blood glucose monitoring systems, ground truth is typically established by laboratory-reference methods (e.g., YSI analyzer) rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable for direct blood glucose measurement devices; it's more relevant to image-based diagnostic systems.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI-assisted interpretation of medical images, which is not the function of a blood glucose monitoring system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone blood glucose meter. Its performance is evaluated by comparing its readings to a reference method, not by an algorithm's performance in abstract. The "standalone" performance is the device's performance in generating a glucose reading. The document confirms "Verification, validation and testing activities were conducted to establish the performance, functionality characteristics of the modified devices," indicating standalone performance evaluation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not explicitly state the ground truth method. For blood glucose monitoring systems, the ground truth for glucose measurements is almost universally established by a traceable laboratory reference method (e.g., using a YSI glucose analyzer), not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not provided. As this device is based on electrochemical biosensor technology and likely uses fixed algorithms, the concept of a "training set" in the context of machine learning (as often seen with AI devices) may not directly apply or is not detailed in this type of 510(k) summary for a blood glucose meter.
9. How the ground truth for the training set was established
This information is not provided, and as noted above, the concept of a "training set" with ground truth in the AI sense might not be applicable here. If internal calibration/development involved a "training set" of samples, the ground truth would typically be established by a laboratory reference 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.