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The Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i 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-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for 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-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 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-1000i 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 text does not contain detailed acceptance criteria or a study design to prove the device meets specific criteria for the Sysmex UF-1000i beyond general statements of equivalence to a predicate device. It primarily focuses on 510(k) submission information, device description, intended use, and a comparison table to its predicate.

Here's an analysis of the available information in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (Sysmex UF-100) through performance comparisons.

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 states: "Data consisting of carryover, linearity, accuracy and reproducibility show performance to the manufacturer's specifications." However, it does not provide:

• The specific sample size used for these studies (test set).
• The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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 provided in the document. The document refers to "manufacturer's specifications" but does not detail how ground truth was established for the comparison studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

The Sysmex UF-1000i is an automated urine particle analyzer, not an AI-assisted diagnostic tool that relies on human readers interpreting its output in a "multi-reader multi-case" study context. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device. It's a standalone automated analyzer.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device is an "automated urine particle analyzer" and operates as an "algorithm only" system. The entire submission details its standalone performance in comparison to a predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for performance evaluation (e.g., manual microscopy by experts, culture results for bacteria). It relies on "comparison to the UF-100" and "manufacturer's specifications" for performance parameters like accuracy and reproducibility.

8. The sample size for the training set

The device described is a flow cytometry instrument that classifies particles based on physical properties (forward scatter, fluorescence, adaptive cluster analysis). While it utilizes "adaptive cluster analysis," which implies some form of algorithmic learning or classification, the document does not specify a "training set" sample size in the context of machine learning. The classification algorithms are likely pre-defined or trained during the instrument's development, but the specifics are not disclosed here.

9. How the ground truth for the training set was established

As with the test set, the document does not specify how ground truth for any potential training data or for the development of its classification algorithms was established.

Summary of missing information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, quantitative acceptance criteria and a comprehensive study report for standalone performance. Many specific details regarding sample sizes, ground truth establishment, expert involvement, and study design are absent. This is common for 510(k) summaries which aim to provide a high-level overview required for regulatory submission. More detailed information would typically be found in the full 510(k) submission document, which is not provided here.

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