(388 days)
The Element ™ plus 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 ™ plus 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 "M plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Element ™ plus 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, forearm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly.
The Element Plus Test strip are for use with the Element Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in capillary whole blood samples drawn from ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
This meter contains some speaking functions but has not been validated for use by the visually impaired.
Element ™ plus Blood Glucose Monitoring System is comprised of test meter, test strip and control solutions. Element "" plus blood glucose test meter is substantially identical with the predicate device (Evolution "M: K072369). The minor difference is that Element "M plus test meter has voice function, which Evolution "" test meter does not have. The voice function can be used as an aid for the users to hear the test results, setting conditions and warning messages. This added function is intended to aid users' convenience.
Element 1 1 plus blood glucose test strip is identical with the predicate device (Evolution 1M. K072369) except the cover design of the test strip. Element "1" plus glucose control solutions are also exactly same as Evolution "M control solutions.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Element™ plus Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative or numerical format, nor does it provide specific reported device performance metrics (e.g., accuracy percentages, bias, precision values).
Instead, the document makes a general statement of equivalence:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Performance | "Test results showed substantial equivalence." |
| Non-clinical Performance | "The device passed all of the tests based on pre-determined Pass/Fail criteria." |
| Disinfection Studies | "CaviWipes™ Disinfecting Towelettes... was validated demonstrating complete inactivation of live virus for use with the meter and the reusable lancing device. There was also no change in performance or in the external materials of the meter and lancing device after 1,095 cleaning/disinfection cycles designed to simulate 3 years of device use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Not explicitly stated. The document only mentions "clinical performance evaluation using the Element™ plus 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. There is no mention of country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The general nature of the "substantial equivalence" statement for clinical performance suggests that a direct evaluation against a clinical ground truth might not have been performed in the same way an AI-driven diagnostic would be evaluated. For a blood glucose monitoring system, the ground truth is typically a laboratory reference method.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a blood glucose monitoring system where results are quantitative and compared against a reference method, an adjudication method for experts (like 2+1 or 3+1) is typically not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No, an MRMC comparative effectiveness study was not done.
- Effect Size (AI vs. without AI assistance): Not applicable, as this is a standalone device without an AI assistance component for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance evaluation was conducted for the device itself. The clinical performance evaluation and non-clinical verification/validation activities described relate to the device's inherent performance.
7. Type of Ground Truth Used
While not explicitly stated as "ground truth," for blood glucose monitoring systems, the reference standard is typically a laboratory reference method (e.g., YSI analyzer) for glucose measurement. The clinical evaluation would compare the device's readings against this reference method.
8. Sample Size for the Training Set
This information is not provided. Blood glucose monitoring systems are typically engineered devices with established biochemical principles, not machine learning algorithms that require a "training set" in the common sense (i.e., for model training). Their development involves calibration and validation, but not typically a "training set" for AI.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable in the context of device development for a blood glucose monitoring system, as it's not an AI/ML-driven device that requires a training set and associated ground truth for model development.
§ 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.