(57 days)
The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-100i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell.
The Sysmex® UF-100i, automated urine cell analyzer is a dedicated system for the analysis of microscopic formed elements in urine specimens. It accomplishes this by the principles of Laser Flow Cytometry and Impedance. The UF-100i attached to a commercially available reagent strip reader provides all that is required to perform an automated urinalysis profile consisting of chemistries and microscopic results.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Sysmex® UF-100i Automated Urine Cell Analyzer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with independent acceptance criteria and data for the new device's performance.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial report for a new medical device.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit): The implicit acceptance criterion is "substantial equivalence" to the predicate device (Sysmex UF-100). The document states:
"Comparison to the UF-100 demonstrated excellent correlation."
- Reported Device Performance: The specific numerical performance (e.g., sensitivity, specificity, accuracy, precision) for each parameter (RBC, WBC, Epithelial Cells, Cast, Bacteria, Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell) is not provided in this summary. The summary only makes a general statement about "excellent correlation" to the predicate for "Accuracy."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
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)
- Not applicable / Not specified. The study described is a comparison to a predicate device, not an independent assessment against a "ground truth" established by experts in the context of a new clinical claim. The predicate device's performance was "established in the previous 510(k) submission."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. No expert adjudication process is described.
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
- No, an MRMC study was not done. This device is an automated analyzer, 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
- Yes, a standalone performance assessment (relative to the predicate) was implied. The device is an automated analyzer, so its performance is inherently standalone. The study was a "Comparison to the UF-100" to "demonstrated excellent correlation." However, the specific metrics of this standalone performance are not detailed in this summary beyond "excellent correlation."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the comparison study was the performance of the predicate device (Sysmex UF-100). The summary states, "Comparison to the UF-100 demonstrated excellent correlation," implying the UF-100's results served as the reference.
- For the predicate device itself, its performance was "established in the previous 510(k) submission," but the type of ground truth used for the predicate is not detailed here.
8. The sample size for the training set
- Not applicable / Not specified. This document does not describe the development of a machine learning model requiring a training set. The device uses "Laser Flow Cytometry and Impedance," which are well-established measurement principles, not typically requiring a distinct "training set" in the context of 510(k) submissions focusing on substantial equivalence to an existing device using the same methodology.
9. How the ground truth for the training set was established
- Not applicable / Not specified. See point 8.
In summary: This 510(k) summary serves to demonstrate that the Sysmex® UF-100i is substantially equivalent to its predicate (Sysmex® UF-100) based on shared intended use, methodology, reagents, and "excellent correlation" in performance. It does not provide the detailed performance metrics or study design typically associated with a de novo submission or a clinical trial for a novel device, as the primary goal here is to show it's "just as good as" an already approved device.
§ 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).