(1281 days)
The YSI 2900C Biochemistry Analyzer is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of venous whole blood samples, fingerstick capillary whole blood samples, serum and plasma in the laboratory.
For in vitro diagnostic use.
Glucose measurements from the YSI 2900C Biochemistry Analyzer are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell tumors. The YSI 2900C Biochemistry Analyzer is not intended for use in the screening or quantitative analysis on neonates. The YSI 2900C Biochemistry Analyzer is not intended for point of care (POC) use.
This test is for prescription use only.
The device under review, the 2900C Biochemistry Analyzer, is a laboratory instrument and In Vitro Diagnostic Device for determining glucose in human whole blood, plasma and serum taken from venous or capillary samples. The 2900C Biochemistry Analyzer is a semi-automated electronic device that incorporates fluidics for sampling, calibrating, and flushing, a membrane-immobilized enzyme-coupled electrochemical detection system with digital electronic control and has graphical user and data interfacing. It is designed for ambient indoor use in a technical laboratory environment.
The system is not intended to be a point of care product and is intended only for professional laboratory use.
The provided text describes the 510(k) premarket notification for the YSI 2900C Biochemistry Analyzer, which is a device for quantitative testing of glucose. It aims to demonstrate substantial equivalence to a predicate device, the YSI 2300 STAT PLUS Analyzer.
Here's a breakdown of the acceptance criteria and study information, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC thresholds). Instead, the studies aim to demonstrate substantial equivalence to a predicate device. The performance metrics discussed are related to the analytical performance of a biochemistry analyzer.
However, we can extract the precision acceptance criterion and its comparison to the predicate device:
| Performance Metric | Acceptance Criteria (from Predicate Device: YSI 2300 STAT PLUS) | Reported Device Performance (YSI 2900C Biochemistry Analyzer) |
|---|---|---|
| Precision | ±2% of the reading or 2.5 mg/dL (25 mg/L, 0.2 mmol/L), whichever is larger | 2% or 2.0 mg/dL whichever is greater |
It's important to note that for other tests like Method Comparison, Linearity, Specificity/Interference, etc., the "acceptance criteria" would be met by demonstrating that the new device's performance is comparable to the predicate, often through statistical equivalence testing within defined analytical limits, rather than fixed numerical thresholds for a specific algorithm output. The document states: "The results of the performance testing confirmed that the YSI 2900C Biochemistry Analyzer demonstrates substantial equivalence to the YSI 2300 StatPlus Analyzer."
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 provides details on the types of studies performed but does not specify the sample sizes used for the test sets in any of the performance studies (Method Comparison, Precision/Reproducibility, Linearity, Specificity/Interference, etc.).
There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature of the samples). The samples are stated to be "human whole blood, plasma and serum taken from venous or capillary samples."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the context of this device. The YSI 2900C Biochemistry Analyzer is an in vitro diagnostic device that quantitatively measures glucose in biological samples. The "ground truth" for its performance is established by comparing its measurements against reference methods or the predicate device, not by expert interpretation of images or clinical data. Therefore, there's no mention of experts establishing a ground truth for a test set in the way one would for an AI-powered diagnostic imaging device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for this type of device. Adjudication methods like "2+1" or "3+1" are typically used in studies involving expert readers interpreting medical images or clinical data, where consensus is needed to establish a "ground truth" when individual expert opinions might differ. For a biochemistry analyzer, the validation involves analytical comparisons to reference methods or a predicate device, not human interpretation requiring adjudication.
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 section is not applicable to this device. An MRMC study is designed to evaluate how AI assists human interpretation, typically in diagnostic imaging. The YSI 2900C Biochemistry Analyzer is a laboratory instrument that provides quantitative measurements; it does not involve human "readers" interpreting output in the same way, nor does it provide "AI assistance" for human interpretation. Its performance is evaluated analytically against established methods.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" system in its operation for measuring glucose. It performs the analysis and provides quantitative results without direct human "interpretation" of a processed image or complex data set. The performance testing described (Method Comparison, Precision, Linearity, etc.) represents the device's inherent analytical capabilities, which is analogous to "standalone" performance for an IVD. There is no "human-in-the-loop" component for the actual glucose measurement process that would affect its analytical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in these performance studies is typically established by:
- Reference Methods: Highly accurate and precise analytical methods (e.g., isotope dilution mass spectrometry) that are considered the gold standard for glucose measurement, or
- Predicate Device: For demonstrating substantial equivalence, the performance of the new device (YSI 2900C) is compared against that of the legally marketed predicate device (YSI 2300 STAT PLUS) across various analytical parameters. The predicate device's established performance serves as the comparative "truth" for demonstrating equivalence.
- Known Concentrations: For linearity and limit studies, samples with precisely known glucose concentrations are used.
The document explicitly states: "A mirror of this testing was also performed concurrently on the predicate device, the YSI 2300 STAT PLUS Biochemistry Analyzer, for demonstration of substantial equivalence." This indicates the predicate device serves as the primary comparative "ground truth" for the equivalence assessment.
8. The sample size for the training set
This section is not applicable in the context of this traditional analytical device. The YSI 2900C Biochemistry Analyzer uses an "enzyme-mediated electrochemical detection" system, not a machine learning or AI algorithm that requires a "training set" of data. Its underlying technology is based on established biochemical and electrochemical principles.
9. How the ground truth for the training set was established
As there is no "training set" for an AI or machine learning algorithm in this device, this question is not applicable. The device's operational parameters and calibration are based on physical chemistry principles and factory calibration/validation, not a data-driven training process.
§ 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.