(63 days)
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.
The Wako L-Type Glu 2 test is an in vitro assay for the quantitative determination of glucose in serum, plasma or urine. It is a highly specific enzymatic method utilizing hexokinase (HK) and glucose-6-phosphate dehydrogens (G-6-PDH) combinationally.
The provided text describes a 510(k) premarket notification for the "Wako L-Type Glu 2" test, which is an in vitro assay for the quantitative determination of glucose. However, the document does not contain all the specific details requested for acceptance criteria and the study proving the device meets them.
Here's a breakdown of the available information based on the request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of reported device performance values. It only states that "The safety and effectiveness of the Wako L-type Glu 2 is demonstrated by its substantial equivalency to Wako." This implies a comparison to a predicate device, but the specific performance metrics for either device are not detailed.
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 available in the provided text.
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 available in the provided text. The device is an in vitro diagnostic for glucose, so expert review in the sense of image analysis by radiologists would not be applicable. For clinical chemistry devices, ground truth is typically established by reference methods or validated instruments, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. Adjudication methods like "2+1" are typically used for subjectively interpreted data (e.g., medical imaging), which is not the case for a quantitative glucose assay.
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 an in vitro diagnostic for glucose measurement and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is for in vitro diagnostic measurement. The device itself performs the measurement; it's not an algorithm that requires human-in-the-loop interaction in the context of interpretation. Standalone performance for this type of device would refer to its analytical performance characteristics (e.g., accuracy, precision, linearity), which are not detailed here beyond the claim of substantial equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated, for quantitative in vitro diagnostic assays like glucose, the ground truth is typically established using reference methods or validated comparator instruments. The document mentions a comparison to "Wako" (presumably an older Wako glucose test or an equivalent method), suggesting a comparative performance study against an established method.
8. The sample size for the training set
This information is not available in the provided text. The concept of a "training set" as understood in machine learning is not directly applicable here. For in vitro diagnostic devices, developmental testing involves analytical validation using various samples (e.g., spiked samples, patient samples spanning the measuring range), but these are usually referred to as validation or verification samples, not a "training set."
9. How the ground truth for the training set was established
This information is not available in the provided text due to the nature of the device and the lack of a "training set" in the machine learning sense.
§ 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.