(232 days)
The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) 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 CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The CareSens N Premier BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) 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 CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier BT Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
CareSens N Premier brand of Blood Glucose Monitoring System is designed to have two variation models, CareSens N Premier BGMS and CareSens N Premier BT BGMS. CareSens N Premier BGMS is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, CareSens N Premier BT BGMS is implemented with all of the changes stated in the submission. The two meters use the same CareSens N Single Test Strip and CareSens Control Solution.
CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System 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 CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System 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 document is a 510(k) premarket notification for a blood glucose monitoring system, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device evaluation, such as expert-based ground truth, MRMC studies, and training set information, are not applicable or cannot be extracted from this document.
However, I can provide information pertaining to the device's performance given the type of medical device it is (a blood glucose monitor):
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a table format for performance beyond what is listed implicitly for substantial equivalence to the predicate device. However, it mentions "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This implies that internal acceptance criteria were met.
The performance characteristics mentioned are primarily those of the device's technical specifications and intended use, which are deemed "Same" as the predicate device (NoCoding1 Plus Blood Glucose Monitoring System, K160742).
| Characteristic | Predicate Device (NoCoding1 Plus) | Candidate Device (CareSens N Premier / BT) | Reported Performance (Implicitly "Passed" or "Same") |
|---|---|---|---|
| Intended Use | Quantitative glucose measurement in fresh capillary whole blood for self-testing at home by people with diabetes. Not for neonates or diagnosis/screening of diabetes. | Same | Met (Substantially Equivalent) |
| Common Name | System, test, blood glucose, OTC | Same | Met (Substantially Equivalent) |
| Test Principle | Electro-chemical reaction, glucose meter measures electrical current generated by enzyme (glucose oxidase) | Same | Met (Substantially Equivalent) |
| Enzyme | Glucose Oxidase (Aspergillus sp.): 2.7 units; Hexaamineruthenium(III) chloride: 45.7 µg; Other ingredients: 1.6 µg | Same | Met (Substantially Equivalent) |
| Measurement Principle | Amperometric method | Same | Met (Substantially Equivalent) |
| Sample Type | Fresh capillary whole blood | Same | Met (Substantially Equivalent) |
| Calibration | Plasma-equivalent | Same | Met (Substantially Equivalent) |
| Coding System | No coding required (Automatic code identification) | Same | Met (Substantially Equivalent) |
| Test Time (sec.) | 5 | Same | Met (Substantially Equivalent) |
| Sample Volume (ul) | 0.5 | Same | Met (Substantially Equivalent) |
| Measurement Unit | mg/dL | Same | Met (Substantially Equivalent) |
| Test Range (mg/dL) | 20-600 | Same | Met (Substantially Equivalent) |
| Operating Humidity | 10~90% | Same | Met (Substantially Equivalent) |
| Power Source | Two 3.0V lithium batteries (CR2032) | Same | Met (Substantially Equivalent) |
| Memory Capacity | Up to 1,000 test results | Same | Met (Substantially Equivalent) |
| Test Result Average Range | 1, 7, 14, 30 and 90 days (Pre-meal, Post-meal, Fasting and Total) | Same | Met (Substantially Equivalent) |
| Operating Temperature | 42.8-111.2°F | Same | Met (Substantially Equivalent) |
| Hematocrit Range (%) | 15~65 | Same | Met (Substantially Equivalent) |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample size for clinical test sets. For disinfection studies, it mentions "260 each of pre-cleaning and disinfection cycles for meter with the same disinfectant designed to simulate 5 years (260 each of pre-cleaning and disinfection cycles for meter and lancing device) of single patient device use". This relates to the durability of the device after disinfection, not its accuracy in reading blood glucose. The provenance of this data is a "commercial testing service."
The document generally refers to "non-clinical verification, validation and testing activities" as having been conducted. Typically, for blood glucose meters, these would involve studies with human subjects (prospective clinical studies) to compare the device readings against a laboratory reference method. However, the details of these studies (e.g., number of subjects, whether prospective or retrospective, country of origin) are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to a blood glucose monitoring system in the same way it would be for an AI/ML diagnostic device. The "ground truth" for a blood glucose meter is typically established by comparing its readings to a gold- standard laboratory reference method (e.g., YSI glucose analyzer), not expert consensus. The document does not specify the number or qualifications of individuals involved in generating this reference data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device. Adjudication methods like 2+1 are used in AI/ML performance studies where human interpretations are being assessed and potentially reconciled. For a blood glucose meter, the measurement is numerical and compared directly to a reference value.
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:
Not applicable. This is a blood glucose meter, not an AI-assisted diagnostic tool that involves human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device (CareSens N Premier / BT Blood Glucose Monitoring System) is a standalone system for measuring glucose. Its performance is evaluated on its own, with the user taking the measurement. There is no separate "algorithm only" performance reported in the context of an AI/ML algorithm.
7. The type of ground truth used:
For blood glucose meters, the ground truth is typically established by comparison to a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. The document does not explicitly state the reference method used but this is standard practice for glucose meters.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a separate "training set" in the machine learning sense. The device is based on electrochemical biosensor technology.
9. How the ground truth for the training set was established:
Not applicable, as it is not an AI/ML device with a training set.
§ 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.