(129 days)
The FORA Premium V10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the FORA Premium V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA Premium V10 Test Strips are for use with the FORA Premium V10 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper-arm, calf and thigh.
This meter has some speaking functions but is not intended for use by the visually impaired.
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA test strips and FORA control solutions (cleared under K093724) with the FORA Premium V10 Blood Glucose Monitoring System.
The provided 510(k) summary for the FORA Premium V10 Blood Glucose Monitoring System does not contain detailed information about the acceptance criteria and the study that proves the device meets them in the format requested.
Specifically, it states: "FORA Premium V10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device. A comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent." And also, "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA Premium V10 Blood Glucose Monitoring System are equivalent to the predicate device."
This indicates that the device's performance was established by demonstrating substantial equivalence to a predicate device (FORA V30 Blood Glucose Monitoring System, K093635), rather than through a detailed, standalone study with specific acceptance criteria and performance metrics presented in this document.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone study details, and training set information) is not available in the provided text.
However, based on the information that is present, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document for the FORA Premium V10, but implied to be "same performance characteristics as the predicate device" (FORA V30 Blood Glucose Monitoring System). For blood glucose monitors, typical acceptance criteria would involve accuracy standards such as ISO 15197 (which often specifies limits like ±15% or ±20% agreement with a reference method within certain glucose ranges), but these are not cited here.
- Reported Device Performance: The document states that the system "has the same performance characteristics as the predicate device" and that a "comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent." No specific numerical performance metrics are provided for the FORA Premium V10 in this summary.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
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. The study appears to be a bench-level comparison to a predicate device, rather than a clinical study requiring expert ground truth establishment for a test set.
4. Adjudication method
- Not applicable/not specified in the provided text.
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 is a blood glucose monitoring system, not an imaging device typically evaluated with MRMC studies or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- "Standalone" performance, in the context of a blood glucose meter, refers to the accuracy of the device itself compared to a reference method. The document indicates that "system accuracy performance" was compared to the predicate device. However, no specific data from such a standalone study (if one was performed) is included in this summary.
7. The type of ground truth used
- Not explicitly stated. For blood glucose meters, the "ground truth" (or reference standard) is typically established using a laboratory-grade, highly accurate glucose measurement method (e.g., YSI analyzer) on venous blood samples. The document doesn't detail the method used to compare against the predicate.
8. The sample size for the training set
- Not applicable/not specified in the provided text. As this relies on substantial equivalence to an existing device and a well-established measurement principle (electrochemical biosensor using glucose oxidase), there isn't a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable/not specified in the provided text.
§ 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.