(529 days)
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended to be used by a single person and should not be shared.
The FORA D40d Blood Glucose plus Blood Pressure 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. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The FORA D40d Test Strips are for use with the FORA D40d Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual at home. The blood pressure is measured by using an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use auto-disabling lancing devices.
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, and upper arm should be done only during steady – state times (when glucose is not changing rapidly).
The FORA Wisdom D40d Test Strips are for use with the FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual at home. The blood pressure is measured by using an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System consists of one monitor, test strip, control solution, and a pressure cuff. The proposed device has been designed, tested, and demonstrated to work together as a system to produce accurate blood glucose test results and blood pressure measurements.
The proposed device contains speaking function which offers step-by-step audio instructions to help users perform a glucose test or take a blood pressure measurement.
The provided text describes the acceptance criteria and performance studies for the FORA D40d and FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring Systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (Study Results) |
|---|---|
| Blood Glucose Accuracy | Met the requirements of ISO 15197 |
| Blood Pressure Accuracy | Met the requirements of ANSI/AAMI SP10 |
| Electrical Safety | Met the requirements of IEC/EN 60601-1:1995 |
| Electromagnetic Compatibility (EMC) | Met the requirements of IEC/EN 60601-1-2:2001 and EN 61326-1:2006 |
| Safety for Lab Equipment | Met the requirements of IEC/EN 61010-1:2001 and IEC/EN 61010-2-101:2002 |
| Electromagnetic Interference (FCC) | Complies with Part 15 of FCC rules |
| Software Functionality | Software validation was performed to verify and validate the system works functionally. |
2. Sample Size Used for the Test Set and Data Provenance
- Blood Glucose (Consumer Study): "consumer study was performed to evaluate the accuracy at fingertip and alternative sites including palm, forearm and upper arm." The specific sample size for this consumer study is not explicitly stated in the provided text.
- Blood Pressure (Clinical Study): "For blood pressure, a clinical study was performed compared to the reference method according to the requirements of ANSI/AAMI SP10." The specific sample size for this clinical study is not explicitly stated in the provided text.
- Data Provenance: The text does not explicitly state the country of origin of the data. It mentions "Taiwan" as the company's address, but not where the studies were conducted. The studies appear to be prospective as they were conducted to evaluate the accuracy of the new device against reference methods and established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth for either the blood glucose or blood pressure studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for either the blood glucose or blood pressure test sets.
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 section is not applicable. The device described is a blood glucose and blood pressure monitoring system, not an AI-assisted diagnostic tool that would involve human "readers" or a comparative effectiveness study of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical monitoring system that directly measures glucose and blood pressure, not an algorithm that performs standalone analysis. The performance studies evaluate the system's accuracy against reference methods.
7. The Type of Ground Truth Used
- Blood Glucose: The ground truth for blood glucose accuracy was established by comparing the device's measurements to results from a YSI-2300, which is a laboratory reference instrument for glucose measurement.
- Blood Pressure: The ground truth for blood pressure accuracy was established using a "reference method according to the requirements of ANSI/AAMI SP10." This standard typically involves comparison against sphygmomanometry measurements performed by trained observers.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The studies described are performance validation/testing studies, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned in the context of machine learning, this question is not applicable. The device's underlying technology and calibration would have been developed and validated during its design and manufacturing process, but this document focuses on the final performance validation.
§ 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.