(304 days)
The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.
The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer that is used in the clinical laboratory to analyze formed elements in urine samples quantitatively and flag for the presence of particles/cells in the sample. It provides screening of abnormal samples, as well as automation and better efficiency in the laboratory. The analyzer reports analysis results on five enumerated parameters in urine: RBC (Red Blood Cells), WBC (White Blood Cells), EC (Epithelial Cells), CAST and BACT (Bacteria). It also reports flagging information on the following parameters in urine: Pathologic Cast; Crystal; Sperm; Yeast like cell; and Mucus. This flagging information alerts the operator for the need of further testing and/or review.
The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is a dedicated system for the analysis of microscopic formed elements in urine and uses a Microsoft® Windows Operating System. The analyzer consists of the following units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples and processes data from the main unit and provides the operator interface with the system; (2) Sampler Unit which supplies samples to the main unit automatically; and (3) Pneumatic Unit which supplies pressure and vacuum to the main unit.
The analyzer uses five reagents-UF-CELLSHEATH (sheath reagent), UF-CELLPACK CR and UF-CELLPACK SF (diluents) and UF-Fluorocell CR and UF-Fluorocell SF (both stains). The quality control material is UF-CONTROL.
The provided text describes the performance data and conclusions for the Sysmex® UF-5000 Fully Automated Urine Particle Analyzer, seeking to prove its substantial equivalence to the predicate device, the Sysmex® UF-1000i. This is a submission for a 510(k) premarket notification, which focuses on demonstrating equivalence rather than establishing novel claims.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of specific acceptance criteria (e.g., target accuracy percentages, precision ranges) that the Sysmex® UF-5000 had to meet. Instead, it describes general categories of performance testing conducted to demonstrate "equivalent performance" to the predicate device:
| Performance Category | Reported Device Performance |
|---|---|
| Limits of Blank, Detection, Quantitation (LoB/LoD/LoQ) | Testing was conducted. (Specific values or comparison to predicate's LoD/LoQ are not detailed in this summary, but the implication is that they are comparable or better, consistent with the smaller minimum particle size detected.) |
| Linearity | Testing was conducted. (Specific ranges or linearity coefficients are not detailed.) |
| Precision (Repeatability & Reproducibility) | Testing was conducted. (Specific CVs or precision limits are not detailed.) |
| Carryover | Testing was conducted. (Specific thresholds or results are not detailed.) |
| Specimen Stability | Testing was conducted. (Specific stability periods or criteria are not detailed.) |
| Reference Interval | Establishment of reference intervals was part of the evaluation. (The specific intervals or how they were established are not detailed.) |
| Method Comparison (Accuracy) | Clinical and analytical validation testing were conducted to show equivalent performance to the predicate Sysmex® UF-1000i analyzer. "Accuracy (method comparison)" was included in the evaluation. (Specific correlation coefficients, bias, or agreement rates for parameters like RBC, WBC, etc., are not provided in this summary section of the 510(k). It only states that the evaluation "established that the performance, functionality, and reliability... are substantially equivalent.") |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set. It mentions "Clinical and analytical validation testing" and "Method Comparison" but provides no numbers of samples or patients.
Regarding data provenance: The document identifies Sysmex America Inc. (Illinois, USA) as the submitter. While it doesn't explicitly state the country of origin for the clinical samples, it's highly likely to be the USA, given the submitter's location and the FDA submission context. The study is implicitly prospective in nature, as it involves newly conducted validation testing for a new device to demonstrate its performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. For a device like an automated cell counter, the "ground truth" for method comparison studies is typically established by comparing its results against a "gold standard" or reference method, which might be manual microscopy performed by trained laboratory professionals (medical technologists, clinical pathologists), or by comparing against the predicate device itself. However, the text does not elaborate on this.
4. Adjudication method for the test set
The document does not describe any adjudication method. Given that the device is an automated cell counter, the "ground truth" would likely be established through a reference laboratory method rather than a panel of human adjudicators in the way an imaging AI might use.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component of the diagnostic pathway. For an automated laboratory analyzer, the performance is assessed against reference methods and statistical agreement with the predicate.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies described are inherently "standalone" in the context of the device's operation. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated device designed to analyze urine samples and report parameters directly. The performance evaluation (LoB/LoD/LoQ, linearity, precision, carryover, method comparison) assesses the device's analytical performance on its own, without direct real-time human intervention in the analysis process itself. Human interpretation of the results (e.g., flagging information leading to further testing) is part of its intended use, but the analytical performance is standalone.
7. The type of ground truth used
The document implies that the ground truth for the performance studies, particularly "Method Comparison," would be established by comparing the Sysmex® UF-5000's results against those of the predicate device (Sysmex® UF-1000i) and/or other established laboratory reference methods for urine particle analysis. It does not explicitly state which ultimate ground truth was used (e.g., pathology, manual microscopy, or clinical outcomes data). For quantitative parameters like RBC and WBC counts in urine, the "ground truth" often refers to the accepted values obtained from a reference measurement method.
8. The sample size for the training set
This document describes a 510(k) submission for an automated laboratory instrument, not a machine learning or AI model in the modern sense that typically involves "training sets." The "algorithm" or measurement principles (flow cytometry, laser detection, specific reagents) are embedded in the device's design. Therefore, the concept of a "training set" as it applies to AI models is not relevant here, and no information on a training set sample size is provided.
9. How the ground truth for the training set was established
As explained above, the concept of a "training set" for the Sysmex® UF-5000 as an automated instrument is not applicable in the same way it would be for AI/ML algorithms. The device's operational parameters and internal algorithms are based on established scientific principles of flow cytometry and are likely refined during product development and engineering, rather than "trained" on a dataset in the AI sense.
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).