(80 days)
The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart" System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The One Touch® UltraSmari™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.
The One Touch® UltraSmart™ System consists of the One Touch® UltraSmart™ Meter, One Touch® Ultra™ Test Strips, One Touch® Ultra™ Control Solution, UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets. The One Touch® UltraSmart™ Meter, when used with the One Touch® Ultra™ Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch® Ultra™ Control Solution verifies the performance of the One Touch® Ultra™ Blood Glucose Test Strips.
The UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets are provided to facilitate obtaining a capillary blood sample.
The provided text is a 510(k) summary for the One Touch® UltraSmart™ Blood Glucose Monitoring System. It does not contain detailed acceptance criteria or a study protocol with the specific information requested in the prompt. Instead, it makes a general statement about performance.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Laboratory studies and clinical studies demonstrate that the One Touch® UltraSmart™ Blood Glucose System provides equivalent performance to the One Touch® Ultra™ Blood Glucose System."
It does not provide explicit numerical acceptance criteria (e.g., specific accuracy percentages, bias limits) or detailed reported device performance against such criteria for the One Touch® UltraSmart™ device itself. It only states equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the summary.
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)
This information is not provided in the summary. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference method of glucose measurement (e.g., a laboratory analyzer), not "experts" in the clinical imaging sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and not provided in the summary. Adjudication is generally relevant to subjective interpretations, often in imaging studies.
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 for this type of device. The device is a blood glucose monitor, not an AI-assisted diagnostic tool interpreted by human readers. No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone glucose measurement system. The "performance data" mentioned in the summary refers to the device's ability to measure glucose. There's no AI algorithm here in the typical sense of a "standalone" performance study. The device provides a direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for performance comparison would be a reference glucose measurement method, likely from a laboratory analyzer, against which the device's readings are compared. However, this is not explicitly stated or detailed in the summary.
8. The sample size for the training set
Not applicable for this type of device. There isn't a "training set" in the context of an AI/machine learning model for this blood glucose monitor.
9. How the ground truth for the training set was established
Not applicable for this type of device, as there is no mention of a training set or AI model.
In summary:
The 510(k) summary only states that laboratory and clinical studies demonstrate equivalent performance to a predicate device (One Touch® Ultra™ Blood Glucose System). It does not provide the specific details of these studies that would answer the requested questions about acceptance criteria, sample sizes, ground truth establishment, or study methodologies. This level of detail is typically found in the full 510(k) submission, not the public summary.
§ 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.