(147 days)
The Element The Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element 101 Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element ™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Element The 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 in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly.
The Element TM Test Strips are for use with the Element M Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The Element ™ control solutions are for use with the Element ™ Blood Glucose Monitoring system to check that the meter and the test strips are working together properly and the test is performing correctly.
The Element™ Blood Glucose Monitoring System consists of the meter, test strips and control solutions (low, normal and high levels). 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.
Here's a breakdown of the acceptance criteria and study information for the Element™ Blood Glucose Monitoring System, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a table format with specific thresholds (e.g., "X% of results within Y% of reference"). Instead, it broadly states that the device passed "pre-determined Pass/Fail criteria" and showed "substantial equivalence" to the predicate device. For blood glucose monitoring systems, performance is typically evaluated against standards like ISO 15197 for accuracy. However, this specific 510(k) summary only provides a high-level qualitative description.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Performance | "Test results showed substantial equivalence [to the predicate device]." |
| Non-clinical Performance | "The device passed all of the tests based on pre-determined Pass/Fail criteria." |
| Disinfection Study | "complete inactivation of live virus" with CaviWipes; "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 Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size used for the clinical performance evaluation (test set). It only states that a "clinical performance evaluation using the Element™ Blood Glucose Monitoring System components were conducted for purpose of validating the consumer use for the user and the professional accuracy."
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission sponsor is Infopia Co.,Ltd. from Korea, which might suggest the studies were conducted there, but this is not confirmed. The document only mentions the "clinical performance evaluation." The type is prospective, as it's a "clinical performance evaluation" rather than an analysis of existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given 510(k) summary. For blood glucose monitoring systems, the "ground truth" (reference measurements) would typically come from a laboratory reference method, not human expert consensus like in imaging studies.
4. Adjudication Method for the Test Set
This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers interpret results and need to reach consensus, often in imaging or pathology. For a blood glucose monitoring system, the "ground truth" comes from a reference laboratory method, not from subjective human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, a MRMC comparative effectiveness study was not conducted. This type of study assesses how human readers perform with and without an AI CAD system, which is not relevant for a blood glucose monitoring device.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no such study was performed or is relevant to this device type.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, a standalone performance evaluation was conducted. The "clinical performance evaluation" and "non-clinical performance evaluation" assess the device's accuracy and functionality in its intended use, typically without human interpretation influencing the measurement result itself. The device itself is the "algorithm" that measures glucose.
7. Type of Ground Truth Used
The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., YSI analyzer, hexokinase method). While the document states "professional accuracy" was validated, it does not explicitly name the specific reference method used.
8. Sample Size for the Training Set
The document does not mention a training set in the context of an AI/ML algorithm. This device is a traditional in vitro diagnostic device, not an AI/ML powered one, so the concept of a "training set" for an algorithm to learn from is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm, this information is not applicable and not provided.
§ 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.