(8 days)
The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home. 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.
The BioScanner Plus, as modified, is an in vitro diagnostic device consisting of both a reflectance photometer and an amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric analysis. The test strips have not been modified. The unmodified BioScanner Plus contains a reflectance photometer. The modified BioScanner Plus has an additional amperometric circuit.
The provided 510(k) summary for the BioScanner Plus device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, the summary focuses on demonstrating substantial equivalence to predicate devices and describes the device's modification and intended use, rather than presenting a performance study with specific acceptance criteria and results.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or report specific performance metrics (e.g., accuracy, precision) that would typically be associated with a device performance study. The submission primarily focuses on the device's design, intended use, and its similarities to legally marketed predicate devices to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any information regarding the sample size used for a test set or the provenance of any data. This type of detail is typically found in a separate performance study section, which is not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of a ground truth establishment process, experts, or their qualifications in this 510(k) summary. This information would be relevant if a clinical or analytical performance study was detailed.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method, as no specific test set or study methodology is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. For a glucose meter, the focus is typically on the device's analytical accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The BioScanner Plus is a quantitative glucose measurement device. Its performance is inherently "standalone" in terms of its ability to measure glucose from a biological sample. A "human-in-the-loop" performance study in the context of interpretation (like with imaging) is not applicable here. The accuracy of the device itself would be evaluated. However, the summary does not detail such an evaluation.
7. The Type of Ground Truth Used
The summary does not explicitly state the type of ground truth used. For a glucose meter, the ground truth for an analytical performance study would typically be a reference laboratory method for glucose measurement (e.g., hexokinase method, YSI analyzer) known for its high accuracy and precision.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this 510(k) summary. This term is most often used in the development of machine learning or AI algorithms. The BioScanner Plus is described as a reflectance photometer and an amperometer, implying a more traditional analytical device with established chemical and optical principles, not one that relies on a machine learning model requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth might have been established.
Summary of Device and 510(k) Submission:
The 510(k) summary describes the BioScanner Plus, an in vitro diagnostic device for quantitative determination of glucose in human whole blood. The submission's primary purpose is to establish substantial equivalence for a modified BioScanner Plus compared to several predicate devices. The modification involves adding an amperometric circuit to the existing reflectance photometer, essentially combining the functionalities of two predicate devices (the BioScanner Plus with reflectance photometry and the BioScanner Beyond Glucose Analyzer with amperometry) into a single new device. The intended use remains the same: for use by healthcare professionals and individuals at home for the diagnosis and treatment of carbohydrate metabolism disorders.
The core of this 510(k) relies on the fact that both the reflectance photometry and amperometry technologies, as well as the test strips, are already cleared through previous 510(k)s (K013173, K972669, K013203). The argument for substantial equivalence is that by combining these already-cleared technologies, the modified device does not raise new questions of safety or effectiveness. Therefore, the submission focuses on comparing the features and technology of the modified device to its predicates, rather than presenting new, detailed performance studies with quantitative acceptance criteria.
§ 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.