(144 days)
TD-4277 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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. Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples.
The kit of TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 consists of: the meter with blood glucose measurement function, test strips and control solutions. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
The provided text describes a 510(k) submission for the TD-4277 Blood Glucose Monitoring System. However, it does not contain the detailed acceptance criteria, specific performance metrics from studies, sample sizes for test or training sets, ground truth establishment methods, or information regarding multi-reader multi-case studies.
The document generally states:
"The laboratory and clinical studies for the performance of TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 demonstrated that the performance of this system meets its intended use."
To answer your request, I must point out that the provided text lacks the specific details requested regarding acceptance criteria, study methodologies, and performance results. Therefore, I cannot generate the table or provide specific answers to most of your questions based solely on the provided input.
However, I can extract the available information and highlight what is missing.
Inferred Information from the Document:
- Device Name: TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277
- Intended Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger. Intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. Not intended for diagnosis or screening for diabetes, and not for use on neonates. Professionals may use test strips for capillary and venous blood samples; lay users may not test venous blood samples.
- Test Principle: Electrochemical biosensor technology using glucose dehydrogenase.
Summary of Requested Information vs. Available Information from Input Document:
| # | Information Requested | Available in Provided Text? |
|---|---|---|
| 1 | A table of acceptance criteria and the reported device performance | No. The document generally states that "laboratory and clinical studies...demonstrated that the performance of this system meets its intended use," but no specific acceptance criteria or performance metrics (e.g., accuracy percentages, bias) are provided. |
| 2 | Sample size used for the test set and the data provenance | No. No details on sample size or data provenance (country, retrospective/prospective) are mentioned. |
| 3 | Number of experts used to establish the ground truth for the test set and their qualifications | N/A. This device is a blood glucose monitoring system, and ground truth for such devices is typically established through a laboratory reference method (e.g., YSI analyzer), not expert consensus in the way medical imaging or pathology devices use experts. The document does not specify the ground truth method or experts involved. |
| 4 | Adjudication method for the test set | N/A. As above, the nature of this device means adjudication by multiple human experts is not typically applicable for establishing glucose ground truth. No information on any adjudication method is provided. |
| 5 | If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size | No. MRMC studies are primarily relevant for human-interpretable diagnostic imaging or pathology, and not typically for automated blood glucose meters. No such study is mentioned. |
| 6 | If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Yes, implicitly. Blood glucose meters are inherently standalone devices by nature. The performance described would be the device's standalone performance. However, no specific details of a separate standalone study are provided, only that "laboratory and clinical studies" were conducted. |
| 7 | The type of ground truth used | No. While it's generally understood that blood glucose meters use a highly accurate laboratory reference method (e.g., YSI glucose analyzer) as ground truth, the input document does not explicitly state the type of ground truth used for these studies. |
| 8 | The sample size for the training set | No. No information on a training set or its size is provided. |
| 9 | How the ground truth for the training set was established | No. No information on a training set or its ground truth establishment is provided. |
§ 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.