(266 days)
Rightest Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Max is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max.
Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus.
GE Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
GE Blood Glucose Monitoring System Max is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max.
GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.
For Over-the-Counter Setting:
Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus, consist of the following devices:
Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.
Rightest Meter Max and Rightest Meter Max Plus, when used with the Rightest Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus are verified by the Rightest Control Solution GC700.
GE Blood Glucose Monitoring System Max and GE Blood Glucose Monitoring System Max Plus, consist of the following devices:
Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.
GE Meter Max and GE Meter Max Plus, when used with the GE Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of GE Blood glucose monitoring System Max and GE Blood glucose monitoring System Max Plus are verified by the Rightest Control Solution GC700.
The provided text pertains to a 510(k) premarket notification for a blood glucose monitoring system, not an AI model. Therefore, direct answers to questions regarding acceptance criteria for an AI device, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI are not applicable.
However, I can extract information related to the performance of the blood glucose monitoring system and present it in a format that mirrors the requested table, as well as address the aspects of the study that were performed.
Here's a breakdown of the information available and how it relates to your questions:
Device: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus. These are glucose test systems (NBW, Class II, 21 CFR 862.1345).
Study Type: This is a premarket notification (510(k)) seeking substantial equivalence to a predicate device (Rightest Blood Glucose Monitoring System GM720, K140210). The studies described are for the performance of a blood glucose meter, not an AI algorithm.
Information applicable to the prompt (adapted for a glucose meter):
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format for distinct performance metrics but rather presents various technical specifications and study results to demonstrate substantial equivalence. The provided information focuses on the technical specifications and a lay user performance study.
| Acceptance Criteria (Implied/Standard for BGMs) | Reported Device Performance (from "Comparison to Predicate Devices" and "Discussion of Non-Clinical Tests") |
|---|---|
| Measurement Technology | Dehydrogenase Electrochemical Sensor |
| Sample Type | Fresh capillary whole blood |
| Alternative Sample Site | Fingertips, palm, forearm. |
| Minimum Sample Volume | 0.75 microliter |
| Test Time | 5 seconds |
| Control Solution | 3 levels (Level 1, 2, and 4) Rightest Control Solution GC700 |
| Operating Conditions (Temperature) | 43 ~111 °F (6 ~ 44°C) |
| Operating Conditions (Relative Humidity) | 10 ~ 90% |
| Meter Storage Conditions | 14 |
| Test Strip Shelf Life (After Opening) | 4 months |
| Hematocrit Range | 10 - 70 % (New Device) vs. 20 - 65% (Predicate Device) |
| Measuring Range | 10-600 mg/dL (New Device) vs. 20-600 mg/dL (Predicate Device) |
| Test Strip Reagent Composition | FAD-Glucose dehydrogenase 12.4 %, Potassium Ferricyanide 49.6 %, Non-reactive Ingredients 38.0 % (New Device) vs. FAD-Glucose dehydrogenase 12.1%, Potassium ferricyanide 48.5%, Non-reactive ingredients 39.4% (Predicate Device) |
| Interference | Dopamine HCl > 2.3 mg/dL, Gentisic Acid > 3.0 mg/dL, Glutathione reduced > 35 mg/dL, Hemoglobin > 10,000 mg/dL, Uric Acid > 10 mg/dL, Maltose > 1900 mg/dL, Xylose > 9.0 mg/dL (New Device) vs. Ascorbic acid > 3 mg/dL; Glutathione reduced >60 mg/dL; Uric Acid > 12 mg/dL (Predicate Device) |
| Accuracy (Lay User Performance Study) | "The study result shows substantial equivalence to comparison method." (Specific numerical performance metrics are not provided in this summary, but would typically be based on ISO 15197 accuracy requirements for blood glucose monitoring systems, e.g., ±15% or ±20% agreement with a reference method for certain glucose concentration ranges). |
| Precision, Linearity, Sample Volume, etc. | Evaluated to establish performance, functionality, and reliability, with results supporting substantial equivalence. (No specific numerical results for these evaluations are provided in the summary) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A "User performance study with 357 participants" was performed.
- Data Provenance: The document does not specify the country of origin. It indicates the manufacturer is Bionime Corporation in Taichung City, Taiwan, and the consultant is in San Juan Capistrano, CA, USA. The study type is for a medical device performance validation, which typically involves prospective data collection. It is implied to be prospective as it's a performance study with participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes a study for a blood glucose meter, not an AI interpretation model. The "ground truth" for a blood glucose meter is typically established by comparing its readings to a laboratory reference method (e.g., a central lab analyzer's measurement of glucose in the same blood sample), not by expert consensus on image interpretation.
4. Adjudication Method for the Test Set
This section is not applicable for a blood glucose meter performance study. Adjudication methods are relevant for subjective interpretations, often in imaging or clinical diagnoses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This section is not applicable. An MRMC study is relevant for evaluating the impact of AI systems on human reader performance, typically in diagnostic imaging. This document describes the performance of a blood glucose meter itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a blood glucose meter. Its performance is inherent to the device's measurement capabilities. The "Lay User Performance Study" evaluates the device's accuracy when used by its intended users (individuals with diabetes at home), which includes a human "user-in-the-loop" aspect, but this is about device usability and accuracy, not AI algorithm standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for blood glucose measurements in such studies is typically comparison to a laboratory reference method. The document states that the "study result shows substantial equivalence to comparison method," implying that the device's readings were compared against a highly accurate laboratory standard.
8. The Sample Size for the Training Set
This section is not applicable. Blood glucose meters are not "trained" in the way AI models are. Their performance is based on their electrochemical design and calibration.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as blood glucose meters do not have a "training set" or "ground truth" established for it in the context of machine learning. Their calibration and performance are validated through rigorous lab testing against reference standards.
§ 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.