(198 days)
The CareSens II, CareSens POP Meters are used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)
CareSens Test Strips work with the CareSens II, CareSens POP meters to quantitatively measure glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)
CareSens Normal and Middle Control Solutions are a red liquid which is to be used to check that both the CareSens meters and CareSens test strips are working together properly. It contains a known range of glucose as specified on the vial.
CareSens Blood Glucose Monitoring System is an in vitro diagnostic device designed to measure the concentration of glucose in capillary whole blood with CareSens Test Strips. The CareSens II model consists of the CareSens II meter, CareSens test strips, CareSens control solution (Normal and Middle ranges), check strips, lancing device, lancets, user manual, quick reference guide and a logbook. CareSens POP model consists of the CareSens POP meter, CareSens test strips and lancing device, lancets, user guide, and quick guide.
The test principle is:
CareSens Blood Glucose Monitoring System is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase. A blood sample is applied to the blood collection area at the tip of the strip and is automatically drawn into the reaction zone, where the glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, a mediator transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of glucose present in the blood sample. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
The provided text describes a 510(k) summary for the CareSens Blood Glucose Monitoring System, which includes information about its intended use, principle of operation, and a comparison to a predicate device. It also mentions a substantial equivalence claim based on clinical data. However, the document does NOT contain explicit acceptance criteria, detailed study design, sample sizes for test and training sets, information about experts, adjudication methods, MRMC studies, or specific ground truth establishment methods as requested in the prompt.
Therefore, many of the requested items cannot be extracted directly from the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "All predetermined acceptance criteria were satisfied." However, the specific acceptance criteria themselves are not detailed in the provided text. The document implies that the device performance was sufficient to demonstrate substantial equivalence to the predicate device. Without the actual acceptance criteria, a table cannot be fully populated.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "All predetermined acceptance criteria were satisfied." The device performed "well with the laboratory glucose reference test equipment." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The study is described as "clinical data." The submitting company is i-SENS, Inc. in Seoul, Korea, suggesting the data may originate from Korea, but this is not explicitly stated as the country of origin for the data used in the clinical study. It is implied to be a prospective study ("The clinical data demonstrates the performance..."), but not explicitly stated as retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. The "ground truth" is referred to as "laboratory glucose reference test equipment," implying a comparison against a gold standard lab method, not expert consensus.
4. Adjudication method for the test set:
- Not applicable as the ground truth appears to be established by comparison to laboratory equipment, not by human expert consensus or adjudication.
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 device is a blood glucose monitoring system, an in-vitro diagnostic device, not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "CareSens Blood Glucose Monitoring System" is an automated device designed to measure glucose concentration. The performance described is that of the device itself, functioning as an algorithm/instrument without direct human interpretation in the loop after the sample is applied. The statement "The clinical data demonstrates the performance of the CareSens Blood Glucose Monitoring System well with the laboratory glucose reference test equipment" refers to its standalone performance.
7. The type of ground truth used:
- "Laboratory glucose reference test equipment." This indicates a comparison against a recognized gold standard method for glucose measurement in a clinical laboratory setting.
8. The sample size for the training set:
- Not specified in the provided text. Blood glucose monitoring systems typically don't have "training sets" in the AI/machine learning sense, but undergo extensive calibration and verification during development. If "training set" refers to samples used for initial calibration or optimization of the device's measurement algorithm, that information is not provided.
9. How the ground truth for the training set was established:
- Not specified. As noted above, the concept of a "training set" with ground truth in the AI sense is not directly applicable to this type of device based on the provided information.
§ 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.