(386 days)
The GE200 Blood Glucose Monitoring System 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. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE200 Blood Glucose Monitoring System 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. The GE200 Blood Glucose Monitoring System 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 GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE300 Talking Blood Glucose Monitoring System 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. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by diabetic individuals at home as an aid to monitor the effectiveness of diabetes control. Only limited audible information is available, not intended as an aid for the visually impaired. The GE300 Talking Blood Glucose Monitoring System 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 GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Series Control Solution are for use with the GE300 Talking Blood Glucose Meter and the GE300 Talking Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The Rightest Blood Glucose Monitoring System GM650 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. The Rightest Monitoring System GM650 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by diabetic individuals at home as an aid to monitor the effectiveness of diabetes control. Only limited and ble, is available, not intended as an aid for the visually impaired. The Rightest Blood Glucose Monitoring System GM650 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 Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Control Solutions GC650 are for use with the Rightest Blood Glucose Meter GM650 and the Rightest Blood Glucose Test Strip GS650 to check that the meter and test strips are working together properly and that the test is performing correctly.
The Rightest Blood Glucose Monitoring System GM700 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. The Rightest Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 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. The Rightest Blood Glucose Monitoring System GM700 should not be used for the 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 Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE200 Blood Glucose Monitoring System consists of the GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, and GE200 Control Solution. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the GE200 Control Solution.
The GE300 Talking Blood Glucose Monitoring System consists of the GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, and GE300 Series Control Solution. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the GE300 Series Control Solution.
The Rightest Blood Glucose Monitoring System GM650 consists of the Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, and Rightest Control Solution GC650. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the Rightest Control Solution GC650.
The Rightest Blood Glucose Monitoring System GM700 consists of the Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, and Rightest Control Solution GC700. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance is verified by the Rightest Control Solution GC700.
The provided document describes the non-clinical and clinical studies performed for the BIONIME Righhtest Blood Glucose Monitoring System (GM700, GM650) and GE Blood Glucose Monitoring System (GE200, GE300) to demonstrate their substantial equivalence. The primary change for these systems is a revised hematocrit (HCT) range for the test strips (GS700/GS650/GS750 for Rightest brand and identical strips for GE200/GE300).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to adherence to ISO 15197:2003 for precision and references other CLSI guidelines for interference studies, but it doesn't explicitly state specific numerical acceptance criteria for each test (e.g., specific bias percentages for linearity or accuracy). However, it consistently states that "the results fall within the acceptance criteria" or "meet the acceptance criteria."
However, for accuracy, the general standard for blood glucose meters within ISO 15197:2003 (which was referenced) is typically:
- **For glucose concentrations ±10% bias at certain concentrations (noted as limitations). |
| Altitude Effect | Stability of bias compared to reference during various operated altitudes within criteria. | Stability of bias compared to REF during various operated altitude were all within the criteria. |
| Operating Temperature/Humidity | Stability of bias compared to reference during various operated temperature and humidity within criteria. | Stability of bias compared to REF during various operated temperature and humidity were all within the criteria. |
| Hematocrit Range | Stability compared to reference during various HCT ranges within criteria. | Stability compared to REF during various HCT ranges were all within the criteria. Acceptable HCT range is 20-65%. |
| Lay User Performance | Lay users could obtain accurate results (implies meeting accuracy standards). | Showed substantial equivalence to predicate device in finger, palm, and forearm positions. |
2. Sample sizes used for the test set and the data provenance:
- Linearity Study Data Provenance: Not explicitly stated, but given it evaluates venous blood samples, it's likely a controlled lab study, probably prospective.
- Precision Study Sample Size:
- Within-day: 500 test strips (across 3 lots)
- Between-day: 300 test strips (across 3 lots)
- Data Provenance: Not explicitly stated, implied controlled lab study, probably prospective.
- Specimen Volume Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
- Interference Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
- Altitude Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
- Operating Temperature and Humidity Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
- Hematocrit Study Data Provenance: Not explicitly stated, likely a controlled lab study, probably prospective.
- System Accuracy Study (Whole Blood) Sample Size: A total of 120 patients participated.
- Data Provenance: Not explicitly stated (e.g., country of origin), but it's a clinical study on patients, which would typically be prospective for this type of accuracy assessment.
- Lay User Study Sample Size: A total of 100 laypersons.
- Data Provenance: Not explicitly stated (e.g., country of origin), but it's a clinical study on lay users, which would typically be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For all the non-clinical studies (Linearity, Precision, Specimen Volume, Interference, Altitude, Operating Temperature/Humidity, Hematocrit), the ground truth was established by a reference method, specifically the YSI 2300 Analyzer. This is an automated laboratory instrument, not human experts.
- For the clinical System Accuracy Study, the comparison was made against "plasma glucose values on reference lab instrument," which is the YSI 2300 Analyzer. No human experts are explicitly mentioned as establishing this ground truth for the test.
- For the Lay User Study, the evaluation method is comparing the lay users' results to a "predicate device." The ground truth for direct accuracy is again, by implication from other studies, the YSI 2300 Analyzer. No explicit mention of human experts establishing ground truth for the test sets in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method by human experts is described in the document for any of the test sets. The ground truth for all quantitative measurements relies on comparison to a reference laboratory instrument (YSI 2300 Analyzer).
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 as the device is a blood glucose monitoring system, not an AI diagnostic tool that human readers would interpret. There are no "human readers" in the context of interpreting results from this device; patients or healthcare professionals read the numerical glucose value displayed by the meter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance of the device (meter and test strip) is inherently standalone as it provides a direct numerical result. The non-clinical studies (Linearity, Precision, Interference, etc.) and the System Accuracy study report on the algorithm's (device's) performance compared to a reference standard without human interpretation as an intermediate step. The "Lay User Study" evaluates the user's ability to operate the device and obtain accurate results, not their interpretation of an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth used for all quantitative performance analyses (linearity, precision, interference, system accuracy, etc.) was a reference laboratory instrument, specifically the YSI 2300 Analyzer, which provides plasma glucose values. This is an objective, instrumental reference method.
8. The sample size for the training set:
- This document is a 510(k) summary for a medical device (blood glucose monitoring system), not an AI/machine learning model. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's operational parameters and calibration are established through engineering and analytical studies, not typically by training a model on a large dataset in the way AI systems are trained.
9. How the ground truth for the training set was established:
- As mentioned above, the concept of a "training set" for an AI model is not applicable to this device. For the calibration and internal algorithms of the blood glucose meter, the ground truth would be established through a rigorous process involving samples with known glucose concentrations, validated by a reference method like the YSI 2300 Analyzer during the device's development and manufacturing.
§ 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.