(161 days)
The Envision™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary 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. ENVISION™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.
The ENVISION™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the ENVISION™ 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 glucose result.
This document describes the regulatory submission for the ENVISION™ Blood Glucose Test System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics as one might find for a novel device or AI/ML product.
As such, the information typically requested in your prompt (e.g., sample sizes for test/training sets, detailed ground truth establishment, MRMC studies, specific performance metrics like F1, accuracy, etc.) is not explicitly provided or applicable in the context of this 510(k) summary for a blood glucose monitor. Blood glucose monitoring systems are evaluated against established performance standards and predicate devices, which typically involve accuracy studies comparing device readings to a laboratory reference method.
However, I will extract and infer the closest available information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to the performance of the predicate device as the benchmark for "substantial equivalence." The reported device performance is a general statement of meeting this equivalence.
| Performance Metric Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Performance | Substantial equivalence to the predicate device (LifeScan One Touch® Ultra® Blood Glucose Monitoring System) validation for consumer use and professional accuracy. | "Test results showed substantial equivalence." |
| Non-Clinical (Verification, Validation, Testing) | Pass/Fail criteria based on specifications cleared for the predicate device. | "Results showed substantial equivalence." |
| Overall Conclusion | As safe, effective, and performs as well as the legally marketed predicate device. | "The ENVISION™ 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 Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "clinical performance evaluation" without providing the number of subjects or samples.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be "prospective" in the sense that performance evaluations were conducted for the purpose of validating the consumer use for the user and the professional accuracy of the ENVISION™ system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided because blood glucose monitoring systems typically use a laboratory reference method (e.g., a YSI analyzer) as the "ground truth" for glucose concentration, not expert consensus on images or other subjective data. No mention of experts for ground truth is made.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for blood glucose measurements is typically an objective laboratory reference method, not an adjudicated expert opinion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is a blood glucose monitor.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone system (monitor + test strips) that provides a direct glucose reading. The "clinical performance evaluation" assessed its accuracy against a reference, which is essentially a standalone performance assessment in a clinical setting. There is no "human-in-the-loop" in the interpretation of the numerical glucose result from the device.
7. The Type of Ground Truth Used
The ground truth implicitly used for accuracy assessments in blood glucose monitoring systems is a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer). While not explicitly stated in the provided text, this is the standard practice for validating such devices. The document refers to "professional accuracy," which implies comparison to a highly accurate reference.
8. Sample Size for the Training Set
Not applicable. This device is a measurement system, not a machine learning model that requires a "training set" in the conventional sense. Its performance is based on the electrochemical reaction and calibrated sensor, not a learned algorithm from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this blood glucose monitoring device.
§ 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.