(128 days)
FORA G31a/TD-4256A is intended for in vitro use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative testing sites in the FORA G31a/TD-4256A Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.
FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31a/TD-4256A glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.
FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31a/TD-4256A Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
FORA G31b/TD-4256B is intended for in vitro use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative testing sites in the FORA G31b/TD-4256B Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.
FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31b/TD-4256B glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.
FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31b/TD-4256B Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System consist of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The provided text describes the 510(k) summary for the FORA G31a/TD-4256A and FORA G31b/TD-4256B Blood Glucose Monitoring Systems. However, it does not contain the detailed performance study results, acceptance criteria, or most of the specific information requested in the prompt.
The document states: "The performance of FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System was studied in the laboratory. The studies demonstrated that the performance of this system meets its intended use." This is a general statement, but no specific data, acceptance criteria, or study design details are provided.
Therefore, I cannot fulfill most of your request from the given text.
Here's a breakdown of what can and cannot be answered based on the provided input:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that performance studies were conducted and met the intended use, but it does not specify the acceptance criteria (e.g., accuracy percentages, bias limits) or report the actual device performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The sample size for the test set and the data provenance are not mentioned in the document. It only states that "studies were conducted in the laboratory."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. This information is not present in the document. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by experts in the context of diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Adjudication methods are not applicable nor mentioned for this type of device and study.
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
- Cannot be provided. MRMC studies are typically for diagnostic imaging devices involving human interpretation. This is a blood glucose meter, and no such study is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided directly in the requested format. A blood glucose meter inherently provides a "standalone" reading (the algorithm processes the electrochemical signal to produce a glucose value). However, the document doesn't explicitly describe a study focused on "algorithm only" performance separate from the device's main function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred based on device type: For blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI analyzer). This is not explicitly stated in the document but is standard for such devices.
8. The sample size for the training set
- Cannot be provided. The document does not mention a training set size. Blood glucose meters typically do not involve "training sets" in the same way machine learning algorithms do, as their measurement principle is electrochemical.
9. How the ground truth for the training set was established
- Cannot be provided. As a training set isn't explicitly mentioned or relevant in the context of typical blood glucose meter development (compared to ML-based systems), how its ground truth would be established is not discussed.
Summary of available information related to performance:
The document states that the device's performance was studied in the laboratory and that these studies demonstrated the system meets its intended use. However, no specific details about these studies (e.g., number of participants, specific glucose ranges tested, comparison to reference methods, accuracy metrics, or acceptance criteria) are provided. The information focuses on the device description, intended use, and substantial equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187).
§ 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.