(247 days)
The Medisign® MM3000 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 Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 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 Medisign® MM3000 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 Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Medisign® Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.
The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.
The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Medisign® Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired.
The Medisign® MM3000 Multi 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 Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.
The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.
Medisign Blood Glucose Monitoring System measures the glucose in the whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase (GOD) on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood referenced test strips.
Medisign MM3000 Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Blood glucose test strips, blood glucose control solutions (1, 2, 3 levels), diabetes management software, and data transporting cable are sold separately.
Medisign MM3000 Multi Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Disposable lancing device, blood glucose test strips, blood glucose control solutions (1,2,3 levels), diabetes management software, and data transporting cable are sold separately.
Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Also, each box may contain 25 test strips packed with single aluminum foiled pack or 50 test strips packed with single aluminum foiled pack. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3ug and buffer & non-reactant - 50.5uq.
Each box of control solutions (1, 2, 3 levels) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL) and Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL).
Here's the information about the acceptance criteria and study for the Medisign MM3000 Blood Glucose Monitoring System, extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria for the Medisign MM3000 Blood Glucose Monitoring System performance (e.g., accuracy percentages or error ranges). Instead, it states that "all tests have been proved satisfactory according to the predetermined acceptance criteria." It also does not present a table of specific reported device performance metrics in relation to these criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against predefined quantitative targets.
However, based on general expectations for blood glucose monitoring systems, acceptance criteria typically revolve around accuracy relative to a laboratory reference method. The measuring range is reported as 20 - 600 mg/dL.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that a "system performance test including human factor study was conducted." However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established by comparative measurements using a laboratory reference method.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method. In the context of blood glucose monitoring systems, "adjudication" usually refers to how discrepancies between the device and the reference method are handled or how multiple readers for a test are reconciled. Since this is an in-vitro diagnostic device measuring a quantitative value, adjudication in the sense of expert consensus on qualitative interpretation is not typically applicable.
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 question is not applicable to the Medisign MM3000 Blood Glucose Monitoring System. This device is an in-vitro diagnostic device for quantitative blood glucose measurement, not an AI-assisted diagnostic imaging or interpretation system that would involve human "readers" or an MRMC study design.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a standalone system for measuring blood glucose. Its performance is evaluated as the algorithm/system without human intervention in the measurement process itself, beyond the user applying the sample. The document states a "system performance test" was conducted, implying standalone performance evaluation.
7. The Type of Ground Truth Used:
While not explicitly stated in detail, the ground truth for blood glucose monitoring systems is invariably established through comparison with a laboratory reference method. The phrase "Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood referenced test strips" implies that plasma-equivalent values (likely derived from a laboratory reference) are the standard against which the device's measurements are calibrated and compared.
8. The Sample Size for the Training Set:
The document does not provide information on the sample size for a training set. Blood glucose meters do not typically undergo a "training" phase in the same way machine learning algorithms do. Their performance is based on the chemical and electrical properties of the test strips and meter, which are developed and validated.
9. How the Ground Truth for the Training Set was Established:
As mentioned above, the concept of a "training set" and associated ground truth establishment is not directly applicable to this type of medical device in the same way it would be for an AI/machine learning system. The device's fundamental performance is based on its electrochemical methodology and calibration, not on learning from a dataset.
§ 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.