(211 days)
The Evolution™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Evolution™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when alucose is not changing rapidly.
The Evolution™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Evolution™ Test strip. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood qlucose result.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it relies on a qualitative assessment of "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (LifeScan One Touch® Ultra ® Blood Glucose Monitoring System (K021819)) for consumer use | "Test results showed substantial equivalence." |
| Substantial equivalence to predicate device for professional accuracy | "Test results showed substantial equivalence." |
| Verification of software requirement specifications based on predicate device specifications | "results showed substantial equivalence." |
| Verification of product requirement specifications based on predicate device specifications | "results showed substantial equivalence." |
| Verification of user interface requirement specifications from risk analysis based on predicate device specifications | "results showed substantial equivalence." |
| Safe, effective, and performs as well as the legally marketed predicate device | "The conclusion drawn from the clinical and non clinical tests is that the EVOLUTION™ Blood Glucose Monitoring System is as safe, as effective, and performs as well as the legally marketed predicate device, the ONE TOUCH(®) Ultra®." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "clinical performance evaluation" but does not specify the sample size for the test set.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "clinical performance evaluation using the EVOLUTION™ Blood Glucose Monitoring System components were conducted for the purpose of validating the consumer use for the user and the professional accuracy." This phrasing generally implies a prospective study conducted for the purpose of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Blood glucose monitoring systems typically use a laboratory reference method as ground truth rather than expert consensus on individual readings.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set. Given the nature of blood glucose measurement, a process like 2+1 or 3+1 expert adjudication would not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging interpretation where human readers analyze independent cases. The study here focuses on the accuracy and performance of a blood glucose meter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the "Performance Data" section discusses "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the EVOLUTION™ Blood Glucose Monitoring System with respect to the predicate device. Testing involved the verification of software requirement specifications, product requirement specifications and user interface requirement specifications from risk analysis." This describes standalone testing of the device itself (its software, product, and user interface) to ensure it meets specifications, which is essentially an algorithm-only performance assessment in the context of a medical device.
7. The Type of Ground Truth Used:
While not explicitly stated as "ground truth," for blood glucose monitoring systems, the implicit ground truth would be a laboratory reference method for glucose measurement. The clinical performance evaluation would compare the device's readings against these highly accurate laboratory results.
8. The Sample Size for the Training Set:
The document does not specify the sample size for any training set. For blood glucose meters, the "training" (calibration) is usually inherent to the manufacturing process and chemistry of the test strips and meter, not a separate data-driven machine learning training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no explicit mention of a separate training set or machine learning model training, the document does not describe how ground truth for a training set was established.
§ 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.