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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 is a 510(k) summary for the Sysmex® UF-1000i with Urinalysis WAM. It details the device, its intended use, and substantial equivalence to a predicate device, but it does not contain detailed information about acceptance criteria or specific studies proving device performance against such criteria for the Urinalysis WAM software.

The key assertion made in the document is about the substantial equivalence of the modified device (UF-1000i with Urinalysis WAM) to the predicate device (UF-1000i without Urinalysis WAM). The document states: "Design validation studies were completed and sample integrity study was performed. and there is no difference between the UF-1000i and the UF-1000i with Urinalysis WAM software." and "The UF-1000i with Urinalysis WAM software demonstrates substantial equivalence to the UF-1000i without the Urinalysis WAM software."

Therefore, the provided text does not offer the specific granular details (acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) that would typically be found in a detailed study report demonstrating performance against acceptance criteria for a new device or a significant modification.

Based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and a study proving the device meets them because this specific detail is not present. The document focuses solely on asserting substantial equivalence through a modification that is stated to have "no difference" in how the core analytical function performs.

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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.

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UF-Check™ is intended for use in the quality control of Sysmex UF-100™ automated urine analyzer. The Sysmex UF-100 is a in vitro medical device for use in urinalysis in clinical laboratories to replace microscopic review of normal and abnormal specimens and to flag specimens containing certain abnormalities.

UF-Check is a suspension of particles representing red blood cells, white blood cells, epithelial cells, casts, and bacteria in a liquid medium. Sysmex UF-Check is supplied in glass bottles containing 47 ml volumes. Three bottles - one of each level- are packaged in one box.

Here's a breakdown of the provided text in relation to your request about acceptance criteria and a study proving device fitness.

It's important to note that the provided text is a 510(k) Summary for a medical device control solution, not a diagnostic device that analyzes patient data. Therefore, many of your requested items, particularly those related to "ground truth," "expert consensus," "training sets," and "human-in-the-loop," don't directly apply in the context of this control device. Controls are used to verify the performance of an analyzer, not to diagnose patients.

However, I will extract what information is present and explain why other parts are not applicable.

Acceptance Criteria and Device Performance

The provided document describes a control solution (UF-Check™) for an automated urine analyzer (Sysmex UF-100™). The "performance" of this control solution would be its ability to consistently produce expected values when run on the analyzer and to remain stable over time.

Study Details (Based on the Provided Text)

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the summary. The text mentions "Studies were performed" (plural), but does not quantify the number of runs, samples, or lots included in these studies for Within Run Precision, Within Lot Precision, and Long Term Stability.
   • Data Provenance: Not explicitly stated. Given it's a 510(k) summary filed by Sysmex Corporation in Long Grove, IL, it's highly probable the studies were conducted internally or through collaborators within the US or by Sysmex's global R&D. The data is retrospective in the sense that the studies were completed before the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable in this context. For a control solution, "ground truth" is typically established by the manufacturer through rigorous analytical characterization methods using reference instruments and gravimetric/volumetric precision measurements during the manufacturing process. The "experts" would be the scientists and engineers involved in developing and characterizing the control, but not in the sense of clinical experts interpreting diagnostic results.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication is usually for subjective interpretations of diagnostic results. For a control solution, performance is measured against pre-defined analytical specifications and expected ranges.

4. 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:

   • Not Applicable. This is a control solution, not an AI-powered diagnostic device. There are no "human readers" interpreting the control's results in a diagnostic fashion, nor is there AI performing diagnoses. The human interaction is usually limited to loading the control onto the analyzer and reviewing the quantitative results generated by the analyzer for quality control purposes.

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

   • Not Applicable. Again, this is a control solution, not an algorithm or diagnostic device. The "standalone" performance for the control would be its intrinsic characteristics and stability, which are what the precision and stability studies assessed.

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

   • Analytical Characterization / Manufacturing Specifications. As explained in point 2, the "truth" for a control solution is its meticulously defined composition and the analytical values ("assayed control") it is designed to produce within specific ranges on the target analyzer. This is established through the manufacturer's internal quality assurance and scientific methods during the development and production of the control.

7. The sample size for the training set:

   • Not Applicable. Control solutions do not have "training sets" in the machine learning sense. Their "performance" is inherent to their chemical and physical composition and manufacturing process, validated through analytical studies.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set.

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