(138 days)
The ReliOn Ultima Advance Blood Glucose Monitoring System is intended for in-vitro diagnostic use in the quantitative measurement of glucose in fresh whole blood for selftesting by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. It is not intended to be used for testing neonatal blood samples. The ReliOn Ultima Advance system is indicated for home (lay user) or professional use in the management of patients with diabetes.
The RellOn Ultima Advance Blood Glucose Monitoring System is intended for in vitro diagnostic use (i.e., external use only) and for the quantitative measurement of olucose in fresh capillary whole blood. Both the modified device (ReliOn Ultima Advance Blood Glucose Monitoring System) and its predicate device, i.e. Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213) are indicated for home (lay user) or professional use.
The modified Reil on Ultima Advance Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and performance specifications as the predicate system. The ReliOn Ultima Advance system utilizes amperometric biosensor technology to measure current generated on disposable test strips.
No changes to the strip have been made since the last clearance (Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213)). The test strips manufacturing process is unchanged and all the performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingerip, forearm, or base of the thumb, by home or professional users. Both the predicate strips (Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213)Jand the ReliOn Ultima Advance Blood Glucose Test Strips use the reagent glucose dehydrogenase with nicotinamide-adenine dinucleotide (GDH-NAD) as co-factor.
The predicate meter uses lot specific calibration information contained on the calibration bar is contained in every box of test strips and is specific to a lot of test strips. The calibration bar contains the lot specific information to allow the meter to convert electrical current into glucose readings via a calibration slope and intercept. The user is instructed to calibrate their meter each time they open and use a new box of test strips.
The ReliOn Ultima Advance meter is programmed with a predetermined calibration slope and there is no requirement for the user to insert a calibration bar into the meter.
The provided 510(k) summary for the ReliOn Ultima Advance Blood Glucose Monitoring System does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, number of experts, expert qualifications, or adjudication methods for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of AI assistance.
- Details on standalone algorithm performance.
- Details on the sample size for the training set or how ground truth for the training set was established.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213)) based on similar technology and intended use, rather than presenting a detailed performance study with specific acceptance criteria.
However, based on the information available, here's what can be extracted:
1. A table of specific acceptance criteria and the reported device performance:
This information is not provided in the given 510(k) summary. The document states: "The ReliOn Ultima Advance Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and performance specifications as the predicate system." This implies that the device's performance meets at least the expectations set by the predicate device, but specific numerical acceptance criteria and reported performance values are absent.
2. Sample size used for the test set and the data provenance:
This information is not provided in the given 510(k) summary.
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 in the given 510(k) summary. For blood glucose monitoring systems, ground truth is typically established against a laboratory reference method, not by expert consensus interpreting images.
4. Adjudication method for the test set:
This information is not provided in the given 510(k) summary.
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:
This is not applicable as the device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device requiring human-in-the-loop performance evaluation. There is no mention of AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a blood glucose monitoring system. Its "standalone" performance refers to the accuracy of its measurement system. While the document mentions it "utilizes amperometric biosensor technology to measure current generated on disposable test strips," and "The ReliOn Ultima Advance meter is programmed with a predetermined calibration slope," detailed standalone performance metrics (e.g., accuracy against a lab reference method like YSI) that would typically demonstrate its compliance with accuracy standards (like ISO 15197) are not explicitly provided in this summary. The statement "all the performance characteristics are unchanged" relating to the test strips, implies that the strips' performance (and thus the system's core measurement capability) is consistent with the cleared predicate.
7. The type of ground truth used:
For blood glucose monitoring systems, the ground truth for performance studies is typically established using a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus or pathology. While not explicitly stated in this summary, this is the standard for such devices.
8. The sample size for the training set:
This information is not provided in the given 510(k) summary. The "training set" concept is more relevant for machine learning algorithms; for this device, a calibration process (e.g., using a predetermined calibration slope) is mentioned, but not a data-driven training set in the AI sense.
9. How the ground truth for the training set was established:
This information is not provided in the given 510(k) summary. The device uses a "predetermined calibration slope," which implies an established calibration process, likely based on measurements against a laboratory reference method, but the details of this ground truth establishment are not given.
§ 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.