(54 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 condition for use statement(s): Rightest System provides plasma equivalent results.
Our Blood Glucose Monitoring System includes Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets. 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 Control Solution. The Check key verifies the status of Rightest meter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Rightest Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner for the clinical study. Instead, it aims to demonstrate "substantial equivalence" to a predicate device and suitability for alternative site testing. The metrics reported are slopes, intercepts, and correlation coefficients (r) from linear regressions comparing the device readings to a reference method (YSI-Plasma). The implicit acceptance criteria are that these statistical measures should be sufficiently close to ideal values (slope of 1, intercept of 0, r close to 1) to establish substantial equivalence.
| Metric (Implicit Acceptance Criteria) | Rightest Fingerstick vs YSI-Plasma (Technician) | Rightest Palmstick vs YSI-Plasma (Technician) | Rightest Armstick vs YSI-Plasma (Technician) | Rightest Fingerstick vs YSI-Plasma (Patient) | Rightest Palmstick vs YSI-Plasma (Patient) | Rightest Armstick vs YSI-Plasma (Patient) |
|---|---|---|---|---|---|---|
| Slope (Ideally 1) | 1.03 | 1.02 | 0.96 | 1.06 | 1.03 | 0.99 |
| Intercept (Ideally 0) | -1.63 | 1.18 | 6.55 | Not Available* | Not Available* | Not Available* |
| r (Correlation) (Ideally 1) | 0.9852 | 0.9862 | 0.9793 | Not Available* | Not Available* | Not Available* |
| Testing Range | 55.7 - 490 mg/dL | 55.7 - 490 mg/dL | 55.7 - 490 mg/dL | 55.7 - 490 mg/dL | 55.7 - 490 mg/dL | 55.7 - 490 mg/dL |
| Test Number (Sample Size) | 134 | 134 | 132 | 134 | 133 | 132 |
*Note: The table for the patient study is truncated in the provided text, only showing slope and test numbers. Intercept and 'r' values are not explicitly stated for the patient study in the snippet provided. Assuming the "not available" cells would be populated if the full table was present.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size (Technician Study):
- Fingerstick: 134
- Palmstick: 134
- Armstick: 132
- Sample Size (Patient Study):
- Fingerstick: 134
- Palmstick: 133
- Armstick: 132
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission for a device manufactured in Taiwan, it's plausible the study was conducted in Taiwan, but this is not confirmed. Clinical tests are generally prospective; however, this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The concept of "experts" to establish ground truth as typically understood in AI/imaging studies (e.g., radiologists interpreting images) is not directly applicable here. For blood glucose monitoring systems, the "ground truth" or reference method is typically an established laboratory analyzer.
- Reference Method for Ground Truth: YSI 2300D (This is a commonly recognized laboratory glucose analyzer, which serves as the gold standard for comparison).
- Qualifications of "Experts": The document mentions "technician" for one part of the study. These would be laboratory technicians trained to operate the YSI 2300D and collect blood samples accurately. No specific number or qualification (e.g., years of experience) is provided for these technicians, as this is standard practice for such laboratory work. For the patient study, patients themselves performed the tests without "experts" determining their glucose level.
4. Adjudication Method for the Test Set:
Not applicable in the context of a blood glucose monitoring system validation study. The "ground truth" is provided by a single, highly accurate laboratory instrument (YSI 2300D), not by multiple human adjudicators reviewing conflicting interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or interpretation tasks, not for quantitative measurement devices like a blood glucose meter. The study focuses on the device's accuracy against a gold standard and its performance across different sample sites and user types (technician vs. patient).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the described studies essentially evaluate the standalone performance of the Rightest Blood Glucose Monitoring System. The device's readings are directly compared to the YSI reference method. While a human uses the device, the focus is on the accuracy of the device's measurement, not on how a human's overall decision-making improves with or without using the device's output. The "algorithm" here is the device's internal measurement process.
7. The Type of Ground Truth Used:
The ground truth used was comparative analysis against a well-established laboratory reference method (YSI 2300D). This is a form of highly accurate quantitative measurement from plasma, serving as the gold standard for glucose levels.
8. The Sample Size for the Training Set:
The document does not explicitly mention separate "training" and "test" sets in the context of machine learning model development. This is a medical device validation study, not an AI model development study. The provided data (132-134 tests per arm) represents the clinical validation data set used to demonstrate performance. The device itself (the glucose meter) is likely calibrated during manufacturing based on internal standards and development data, but this "training set" information is not included in this 510(k) summary.
9. How the Ground Truth for the Training Set was Established:
As mentioned above, information regarding a "training set" for an AI algorithm is not applicable here. For the calibration and development of the glucose meter itself, the ground truth would typically be established using:
- Reference solutions: Solutions with precisely known glucose concentrations.
- Laboratory reference methods: Similar to the YSI method used in the validation study, but applied during the device's development and calibration phases.
- Statistical process control: To ensure consistency and accuracy during manufacturing.
This information, however, is part of the device's design and manufacturing process and is not detailed in this specific 510(k) summary, which focuses on clinical validation for market clearance.
§ 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.