(118 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 people with diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This test device is not intended for testing neonate blood samples.
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Two Control Solutions, Lancing Device and lancets. The Rightest Meter, Blood Glucose Test Strips are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.
Here's a summary of 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 doesn't explicitly state "acceptance criteria" in a numerical or categorical format for performance metrics. Instead, it demonstrates performance through a comparison with a reference method (Olympus AU2700) and describes linearity and correlation. However, we can infer performance goals from the presented data (e.g., slopes close to 1).
| Performance Metric | Acceptance Criteria (Implied/Inferred) | Reported Device Performance (Rightest BGMS GM100) |
|---|---|---|
| Linearity (Slope vs. Olympus-Plasma) | Ideally 1.0 (indicating perfect agreement) | Fingertrick: 0.99 |
| Palmstick: 0.96 | ||
| Armstick: 0.96 | ||
| Linearity (Intercept vs. Olympus-Plasma) | Ideally 0.0 (indicating no systematic bias) | Fingertrick: 0.74 |
| Palmstick: 6.35 | ||
| Armstick: 0.46 | ||
| Correlation Coefficient (r vs. Olympus-Plasma) | Ideally 1.0 (indicating strong correlation) | Fingertrick: 0.993 |
| Palmstick: 0.990 | ||
| Armstick: 0.987 | ||
| Test Range | Sufficient to cover diabetic glucose levels | 20 - 600 mg/dL |
| Sample Source Equivalence | Demonstrate comparable results across different alternative sites (fingertip, palm, forearm) | Slopes and intercepts for fingertip, palm, and forearm are similar, showing substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 164 for each test site (fingerstick, palmstick, armstick).
- Data Provenance: The document doesn't explicitly state the country of origin. It describes the study as "clinical test was designed in Alternative site testing study" and conducted by "Technician," but no information about recruitment location is provided. The study appears to be prospective as it involves the collection of blood samples for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given text. The ground truth (reference values) was established using the Olympus AU2700, which is an automated laboratory analyzer, not human experts.
4. Adjudication Method for the Test Set:
This information is not applicable as the ground truth was established by an automated reference analyzer (Olympus AU2700), not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a Blood Glucose Monitoring System, an in vitro diagnostic device that provides a direct numerical result. It does not involve human readers interpreting images or data where AI assistance would be relevant in the context of an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done. The study directly compares the results of the Rightest Blood Glucose Monitoring System (algorithm only) to a reference laboratory instrument (Olympus AU2700) without human intervention in the device's measurement process.
7. The Type of Ground Truth Used:
The ground truth used was reference laboratory method results from the Olympus AU2700 analyzer which measures "Olympus-Plasma" glucose concentrations. This serves as the comparative standard for the device's performance.
8. The Sample Size for the Training Set:
This information is not provided in the supplied text. The document describes clinical validation but does not detail the training set used for the device's development.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the supplied text.
§ 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.