(673 days)
The FORA POCT S10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is indicated for multiple patients use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control program. The system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus. It is not intended for use on neonates.
The FORA POCT S10 Blood Glucose test strips are for the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. The FORA POCT S10 test strips are for use only with the FORA POCT S10 Blood Glucose meter.
The FORA POCT S10 Blood Glucose Monitoring System is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The test principle of the system utilize 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 whole blood and control solutions.
The provided 510(k) summary for the FORA POCT S10 Blood Glucose Monitoring System is very brief on the details of its performance studies. As such, a significant portion of the requested information cannot be extracted from this document.
Here's what can be gathered and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. Performance characteristics of the predicate device (TaiDoc Professional Glucose Test Strips) are implied as the benchmark. | "The performance of FORA POCT S10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device." |
| Specific performance metrics (e.g., accuracy against a lab reference, precision, linearity) are not provided in this summary. | "The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of this system meets its intended use." (No specific results given) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. For blood glucose monitoring systems, the "ground truth" is typically established by comparative measurements against a laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer), not by human experts adjudicating images.
4. Adjudication method for the test set
- Not applicable as the ground truth is established by a reference laboratory method, not by expert adjudication.
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
- Not applicable. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. Blood glucose meters operate in a standalone manner, providing a direct measurement. The "algorithm" here refers to the electrochemical method used by the device to convert the electrical current into a glucose concentration. The performance studies mentioned (system accuracy, meter reliability) would represent standalone performance.
7. The type of ground truth used
- The document does not explicitly state the type of ground truth used. However, for blood glucose monitoring systems, the ground truth is typically established by comparison to a laboratory reference method (e.g., a central laboratory analyzer such as a YSI glucose analyzer) on the same blood samples. This is commonly referred to in performance studies for such devices, even if not explicitly detailed in this summary.
8. The sample size for the training set
- Not applicable in the context of this traditional medical device. This device does not appear to be an AI/Machine Learning device that utilizes a "training set" in the conventional sense. Its performance is based on the underlying chemical/electrochemical principles and calibration, not on a learned model.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for this type of device.
Summary of Missing Information:
The 510(k) summary provides minimal detail regarding the performance studies. Key missing information includes:
- Specific numerical acceptance criteria for accuracy (e.g., bias, CV, % within clinical error limits like ISO 15197 standards).
- Detailed results of the system accuracy study.
- Sample sizes for performance evaluations (e.g., number of subjects, number of blood samples).
- Details of the reference method used for ground truth and its performance characteristics.
- Information about the study design (e.g., site, demographics of participants, full blood glucose range tested).
This brevity is common in 510(k) summaries, which are intended to be high-level overviews. The more detailed performance data would typically be found in the full 510(k) submission not publicly available, or in a separate clinical study report if one was published.
§ 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.