(169 days)
The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples.
Special conditions for use statement(s): Rightest System provides plasma equivalent results.
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets. The Rightest Meter, Blood Glucose Test Strips, Code Key and Check key are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Test Strips is verified by the Control Solution. The Check key verifies the status of Rightest meter.
Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the clinical study design, which focuses on demonstrating substantial equivalence to a predicate device and strong correlation with a lab reference method (YSI 2300D). The performance is presented through linear regression statistics (slope, intercept, and correlation coefficient 'r').
| Acceptance Criteria (Implied) | Device Performance (Rightest BGMS) - Technician Study | Device Performance (Rightest BGMS) - Patient Study |
|---|---|---|
| Strong linear correlation with YSI-Plasma reference method: | ||
| Slope close to 1.00 | Fingerstick: 0.99 | Fingerstick: 1.03 |
| Palmstick: 1.01 | Palmstick: 1.02 | |
| Armstick: 0.99 | Armstick: 1.02 | |
| Intercept close to 0 | Fingerstick: 2.51 | Fingerstick: -0.25 |
| Palmstick: 1.70 | Palmstick: 1.19 | |
| Armstick: 2.21 | Armstick: -0.84 | |
| High correlation coefficient (r) (e.g., > 0.98 or similar) | Fingerstick: 0.9901 | Fingerstick: 0.9911 |
| Palmstick: 0.9910 | Palmstick: 0.9912 | |
| Armstick: 0.9882 | Armstick: 0.9906 | |
| Suitability for alternative site testing (finger, palm, arm) | Demonstrated by similar slopes and intercepts across sites for both technician and patient studies. | Demonstrated by similar slopes and intercepts across sites for both technician and patient studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Technician Study:
- Fingerstick: 176
- Palmstick: 176
- Armstick: 174
- Patient Study:
- Fingerstick: 176
- Palmstick: 175
- Armstick: 174
- Technician Study:
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective, as it describes a clinical evaluation designed to test the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The ground truth was established by the YSI 2300D laboratory reference method, not by human experts in a subjective sense. Therefore, the concept of "number of experts" and their "qualifications" doesn't directly apply in the way it would for image-based diagnostics. The YSI 2300D is an automated analyzer, representing an objective standard.
4. Adjudication Method for the Test Set
- No adjudication method is described for the test set. The comparison is directly between the Rightest BGMS readings and the YSI 2300D reference values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. The Rightest Blood Glucose Monitoring System is a quantitative measurement device, not an interpretive one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the clinical study essentially constitutes a standalone performance evaluation. The "Rightest" device's readings are directly compared to the reference standard (YSI-Plasma) without human intervention in the interpretation of the device's output. The "human-in-the-loop" aspect for a blood glucose meter is the patient or healthcare professional using the device and acting on its numerical output, not interpreting a complex AI output.
7. The Type of Ground Truth Used
- The ground truth used was an objective laboratory reference method: YSI 2300D (YSI-Plasma). This is considered a highly accurate and precise standard for measuring blood glucose.
8. The Sample Size for the Training Set
- The document does not provide information about a specific "training set" or its sample size. This suggests that the device, being a chemical/enzymatic sensor system, likely relies on established electrochemical principles and calibration procedures rather than a machine learning model that requires a distinct training phase with labeled data in the way AI algorithms often do. Its development likely involved extensive bench testing and calibration rather than a "training set" as understood in contexts like deep learning.
9. How the Ground Truth for the Training Set was Established
- As a training set is not explicitly mentioned or implied for a machine learning model, the method for establishing its ground truth is not applicable from the provided text. The device's calibration and accuracy would be verified against reference standards during its development and manufacturing, which is distinct from "ground truth" for an AI training set.
§ 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.