(259 days)
The Element™ V Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, palm, hand, upper-arm, forearm, calf, and thigh. The Element™ V Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Element™ V Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Element™ V test strips are for use with the Element™ V meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the finger, palm, hand, upper-arm, forearm, calf and/or thigh.
The Element™ V control solutions are for use with the Element™ V meter and the Element™ V test strips to check that the meter and test strips are working together properly and the test is performing correctly.
This meter contains some speaking functions but has not been validated for use by the visually impaired. By adding the voice function, users can hear test results, setting conditions and warning messages (errors) while performing the test. This added function is intended to aid users for their convenience.
The Element™ V Blood Glucose Monitoring System consists of the meter, test strips and control solutions (Level 1, Level 2 and level 3). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
The provided text contains limited information about the acceptance criteria and details of the clinical study, making it challenging to extract all the requested information comprehensively. However, I will do my best to present the available details in the requested format.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list specific numerical acceptance criteria (e.g., accuracy percentages within certain glucose ranges) for the Element™ V Blood Glucose Monitoring System. It generally states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy / Substantial Equivalence to Predicate Device | "Test results showed substantial equivalence." |
| "device is as safe, as effective and performs as well as the legally marketed predicate device" | |
| Performance, Functionality, Reliability | "The device passed all of the tests based on pre-determined Pass/Fail criteria." |
| Disinfection Efficacy | "Validated demonstrating complete inactivation of live virus" with CaviWipes. |
| Durability after Disinfection | "no change in performance or in the external materials of the meter and the lancing device after 1,095 cleaning/disinfection cycles" |
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 (Clinical): The document states "The clinical performance evaluation... was conducted for purpose of validating the consumer use for the accuracy." It does not specify the number of participants or samples used in this clinical accuracy study.
- Data Provenance: Not explicitly stated, but the applicant company (Infopia Co., Ltd.) is based in Korea. It's common for initial studies to be conducted in the country of origin. The study is referred to as a "clinical performance evaluation," which typically implies a prospective design for validating accuracy.
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 a laboratory reference method, not by human experts interpreting results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret data (e.g., imaging studies). For objective measurements like blood glucose, accuracy is determined by comparison to a reference standard, not by expert consensus on the device's reading.
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
This information is not applicable. The Element™ V Blood Glucose Monitoring System is a standalone device for quantitative glucose measurement, not an AI-assisted diagnostic tool that would involve human readers interpreting output or an MRMC study design.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the primary clinical performance evaluation described is for the standalone device (Element™ V Blood Glucose Monitoring System) measuring glucose. Its accuracy is evaluated without a "human-in-the-loop" to interpret the results beyond the user following instructions to obtain a reading. The voice function is an aid for convenience, not an interpretation element.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is universally established by laboratory reference methods (e.g., YSI analyzer, or other highly accurate, traceable laboratory-grade glucose measurement devices). It would not be expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not provided. The text focuses on the clinical performance evaluation for validation. It does not mention details about algorithm development or training sets, which are more common for AI/ML-based devices.
9. How the ground truth for the training set was established
This information is not provided and likely not applicable in the context of this device's technology. As it's an electrochemical glucose meter, the "training set" concept (as understood in machine learning) is not directly relevant to its core operational principle. If any internal calibration or algorithm adjustments were made during development, they would typically rely on comparisons to laboratory reference methods, but this is not detailed.
§ 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.