(251 days)
The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario meter is connected to a SMD through a standard 3.5mm audio plug in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.
The provided text describes the Dario Blood Glucose Monitoring System and its substantial equivalence determination. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that the device "meets all of its associated specifications" and that performance and safety testing "confirmed the proposed device to be substantially equivalent to the predicate device." However, specific numerical acceptance criteria (e.g., accuracy percentages) are not explicitly stated in this summary. The categories of performance assessed include:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In Vitro Performance | Meets all associated specifications |
| Software | Documentation prepared and submitted for a moderate level of concern device in accordance with FDA guidance |
| Electrical Safety | Successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety |
| Electromagnetic Interference | Successfully met all relevant sections (Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and power frequency magnetic field immunity test) to satisfy compliance |
| Repeatability Precision | Confirmed to be substantially equivalent to the predicate device |
| Intermediate Precision | Confirmed to be substantially equivalent to the predicate device |
| Linearity | Confirmed to be substantially equivalent to the predicate device |
| Operating Conditions | Confirmed to be substantially equivalent to the predicate device |
| Altitude | Confirmed to be substantially equivalent to the predicate device |
| Accuracy | Confirmed to be substantially equivalent to the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a "User Performance study" for the expanded indications. However, the specific sample size used for this study is not provided in the given text.
- Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Given that this is a Blood Glucose Monitoring System, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" as typically understood in imaging diagnostics (human readers reviewing cases) is not applicable. The "User Performance study" mentioned would likely involve human users operating the device, but not in the context of interpreting results in a comparative effectiveness study with AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Dario Blood Glucose Monitoring System comprises "the Dario Blood Glucose Meter, Dario Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component." The description states, "The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function." This implies that the core glucose measurement performance is inherent in the meter and test strips, which would have been tested in a standalone manner (in vitro performance). The app primarily acts as a display. The "User Performance study" would involve human users operating the system, incorporating a "human-in-the-loop" aspect for usability and performance in real-world scenarios.
7. The Type of Ground Truth Used
For a blood glucose monitoring system, the ground truth for accuracy and precision studies is typically established using:
- Reference laboratory methods: Such as a YSI glucose analyzer, which is considered highly accurate for blood glucose measurements.
- Clinical laboratory results: From comparative devices.
While not explicitly stated as "ground truth" in the provided text, the "In Vitro" performance and "Accuracy" assessments would rely on comparison to these established reference methods.
8. The Sample Size for the Training Set
This information is not provided in the given text, as the device is not described as having an AI algorithm that requires a training set in the conventional sense (e.g., for image recognition). The "Software" section refers to documentation for a moderate level of concern device, which typically relates to software validation and verification, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI algorithm or a training set in the conventional sense, this information is not applicable and therefore not provided in the document.
§ 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.