(88 days)
The ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips are intended for use with ONE TOUCH ® Brand meters by healthcare professionals and laypersons with diabetes at home to provide a quantitative measurement of glucose in whole blood as an aid in managing their glycemic state.
The ONE TOUCH® Blood Glucose Monitoring System is an in vitro diagnostic product consisting of a test strip impregnated with reagents and a reflectance photometer for the determination of glucose in whole blood. Several different ONE Touch ® Brand reflectance photometers may be used (the ONE TOUCH ® Basic, ONE Touch ® II, or the ONE TOUCH ® Profile Meter). A quality control solution, ancillary devices to aid obtaining a capillary blood sample (lancets and lancing device) as well as data management computer software are also available.
A ONE Touch ® Test Strip is inserted into the meter and a drop of blood applied to the test spot. Glucose oxidase present in the test strip catalyzes the reaction of qlucose in the sample with oxygen to yield gluconic acid and hydrogen peroxide. Hydrogen peroxide subsequently oxidizes dyes in the test strip in the presence of peroxidase, a second enzyme, to produce a blue colored form of the dyes. The intensity of the blue color produced is proportional to the amount of glucose in the sample. The meter measures the amount of light reflected by the blue product and converts it to a glucose concentration that is presented on the meter display. The user adjusts the meter response for each lot of test strips by entering a calibration code that is specific to that lot into the meter.
No modifications to the intended use or to the fundamental scientific technology of the ONE Touch® Blood Glucose Monitoring System are being made. The description above applies to the currently marketed device and will apply equally to the modified device described in this submission.
The provided text is a 510(k) summary for the ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips. It focuses on demonstrating substantial equivalence to a predicate device, primarily through a change in test strip dimensions to allow for a smaller blood drop. The document does not contain the detailed information necessary to answer all the points of your request regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML powered device.
Here's an breakdown of what can be extracted and what is missing, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The performance of the modified test strip has been shown to be equivalent to that of the predicate through the acceptable hematocrit range (30% to 55%)."
However, it does not provide a specific table of acceptance criteria (e.g., accuracy metrics like bias, standard deviation, or specific error grid analysis targets commonly used for glucose meters) nor the reported device performance data against those criteria. It only makes a general statement about equivalence regarding hematocrit range.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing. It also does not provide data provenance (e.g., country of origin, retrospective or prospective nature of the data).
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 applicable and not provided in this document. The device is a blood glucose meter, and its 'ground truth' for glucose measurement typically refers to a reference laboratory method, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used when human interpretation (e.g., of images) is involved in establishing ground truth.
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 information is not applicable and not provided. This is not an AI/ML powered device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be relevant or conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a standalone blood glucose meter. Its performance is inherent in its design and operation. The statement "The performance of the modified test strip has been shown to be equivalent to that of the predicate..." implies a standalone performance comparison. However, specific details about a "standalone study" with detailed methodologies and results are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a blood glucose meter, the 'ground truth' would typically be reference laboratory glucose measurements (e.g., using a YSI glucose analyzer or a similar laboratory-grade method). However, the document does not explicitly state the type of ground truth used.
8. The sample size for the training set
The document does not mention a "training set" as this is not an AI/ML device. The "training" in the context of a blood glucose meter typically refers to the calibration (entering a code for each lot of test strips), not a machine learning training phase.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/ML context, this information is not applicable and not provided.
Summary of what is available from the document:
The provided 510(k) summary focuses on demonstrating that a modification to an existing blood glucose test strip (ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips) does not alter its fundamental performance. The key assertion is that the "performance of the modified test strip has been shown to be equivalent to that of the predicate through the acceptable hematocrit range (30% to 55%)." This implies that the acceptance criteria for equivalence related to hematocrit performance were met, but the specific criteria and corresponding performance data are not detailed in this public summary document.
§ 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.