(118 days)
The Sysmex® UF-500i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-500i 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 and Mucus.
The Sysmex® UF-500i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-500i is equipped with a Sampler that provides continuous automated sampling for up to 60 tubes. The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-500i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
The provided document primarily consists of a 510(k) summary for the Sysmex® UF-500i, an automated urine particle analyzer. It focuses on demonstrating substantial equivalence to a predicate device (Sysmex® UF-1000i) rather than presenting a standalone study with detailed acceptance criteria and performance against those criteria in a typical clinical study format.
Therefore, many of the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not explicitly stated within this 510(k) summary. These types of detailed studies are generally performed during the development and validation phases and are summarized or referenced in the 510(k) where substantial equivalence to a known predicate is the primary claim.
Here's an attempt to answer your questions based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study with specific thresholds for sensitivity, specificity, accuracy, etc. Instead, it refers to "method and flagging comparison studies along with reference interval comparison to the UF-1000i," concluding that "there is no difference between the UF-1000i and the UF-500i."
This implies that the acceptance criterion was demonstrating "no difference" or substantial equivalence to the predicate device (Sysmex® UF-1000i) in terms of its ability to analyze and flag specific parameters.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Sysmex® UF-1000i) in terms of analytical performance for: | "Method and flagging comparison studies along with reference interval comparison to the UF-1000i were performed and there is no difference between the UF-1000i and the UF-500i." |
| - RBC analysis | Reported as "no difference" compared to UF-1000i. |
| - WBC analysis | Reported as "no difference" compared to UF-1000i. |
| - Epithelial Cells analysis | Reported as "no difference" compared to UF-1000i. |
| - Cast analysis | Reported as "no difference" compared to UF-1000i. |
| - Bacteria analysis | Reported as "no difference" compared to UF-1000i. |
| - Flagging of Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast-like cell, and Mucus | Reported as "no difference" compared to UF-1000i. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for the comparison studies. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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
An MRMC study is not applicable here because the device is an automated urine particle analyzer. It processes urine samples directly and classifies elements, not assisting human readers with interpretation of images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (Sysmex® UF-500i) is an automated urine particle analyzer. It operates as a standalone algorithm (flow cytometry and adaptive cluster analysis) without human-in-the-loop for its primary analysis and classification of particles. The comparison studies described in the 510(k) summary would have evaluated this standalone performance against the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for comparison was the performance of the predicate device, the Sysmex® UF-1000i. The studies focused on demonstrating that "there is no difference" between the UF-500i and the UF-1000i, meaning the UF-1000i's established performance served as the reference or "ground truth" for the comparison. It indicates "method and flagging comparison studies" which would typically involve comparing the results of both instruments on the same samples.
8. The sample size for the training set
The document does not provide information about a "training set" as this device is a substantial equivalence claim to an existing technology (flow cytometry with adaptive cluster analysis) rather than a novel AI/ML algorithm that would typically undergo explicit training on a large dataset. The underlying analysis principles are established.
9. How the ground truth for the training set was established
As there's no explicit mention of a "training set" for a novel AI/ML algorithm in this 510(k) summary, this question is not directly applicable. The device relies on established flow cytometry principles and classification algorithms.
§ 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).