(323 days)
The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio MD100 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 TysonBio MD100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure qlucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro 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 auto-disabling, single-use lancing devices. The TysonBio MD100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio MD100 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Blood Glucose Monitoring System.
The TysonBio MD100 Pro Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Pro Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Pro Blood Glucose Monitoring System.
The TysonBio MD100 / MD100 Pro Blood Glucose Monitoring System consists of:
a. TysonBio MD100/MD100 Pro Blood Glucose Meter
b. TysonBio MD100/MD100 Pro Test Strips
TysonBio MD100 Control Solution
The provided text does not contain specific acceptance criteria or an analytical study that proves the device meets those criteria. It is a 510(k) summary document that describes the device, its intended use, and states that performance studies were conducted and the device meets its intended use, but it does not detail these studies or their results in a way that allows for the extraction of the requested information.
Therefore, many of the requested details cannot be provided from this document.
However, based on the information that is present, I can provide the following:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The document states "The performance of TysonBio MD100 / TysonBio MD100 Pro Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use." However, it does not specify what those acceptance criteria were or what the actual reported performance metrics were against those criteria (e.g., accuracy percentages, bias, precision data).
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The document mentions "healthcare professionals" were involved in clinical settings, but does not specify their number or qualifications for establishing ground truth.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
This information is not provided in the document. The device is a blood glucose monitoring system, which typically involves direct use by individuals or healthcare professionals rather than interpretation of medical images by multiple readers. Therefore, an MRMC study is highly unlikely for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a Blood Glucose Monitoring System, which by its nature is a standalone device that provides direct measurements to the user or healthcare professional. There is no "human-in-the-loop performance" that would be separate from the device's own measurement. So, in essence, the device's performance is its standalone performance. However, the document does not provide the details of this standalone performance.
7. The Type of Ground Truth Used:
The document implies that the ground truth for glucose measurements would be established through a reference method or laboratory analyzer, as is standard for glucose monitoring systems. While not explicitly stated, the phrase "quantitatively measure glucose" and the nature of the device suggest that comparison would be made against a more precise, established glucose measurement method.
8. The Sample Size for the Training Set:
This information is not provided in the document.
9. How the Ground Truth for the Training Set was Established:
This information is not provided in the document.
§ 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.