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.

Device Description

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.

AI/ML Overview

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.

Summary

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JAN 4 2006

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 053135

1. Submitted by:	Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: November 4, 2005
2. Name of Device:	Trade or proprietary name: Sysmex® Automated Urine CellAnalyzer, UF-100i
	Common name: Automated Urine Cell Analyzer.
	Classification name: Sysmex® UF-100i, Automated Urine CellAnalyzer, is a Urine Particle Counter (21 CFR 864.5200) is aClass II medical device.
3. Predicate Method:	The Sysmex® UF-100i claims substantial equivalence to the UF-100, the predicate method.
4. Device Description:	The Sysmex® UF-100i, automated urine cell analyzer is adedicated system for the analysis of microscopic formed elementsin urine specimens. It accomplishes this by the principles ofLaser Flow Cytometry and Impedance. The UF-100i attached toa commercially available reagent strip reader provides all that isrequired to perform an automated urinalysis profile consisting ofchemistries and microscopic results.
5. Intended Use:	The Sysmex® UF-100i is an automated urine cell analyzer for invitro diagnostic use in screening patient populations found inclinical laboratories. The UF-100i analyzes the followingparameters in urine samples: RBC, WBC, Epithelial Cells, Cast,and Bacteria and flags the presence of the following: PathologicCast, Crystal, Sperm, Small Round Cell, Yeast like cell.
6. Substantialequivalence-similaritiesand differences:	The following table compares the UF-100i with the UF-100, thepredicate method.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Sysmex UF-100		Sysmex UF-100i
	Predicate	Modification of Predicate
Intended Use	The SysmexTM UF-100 is intended forin vitro diagnostic use in clinicallaboratories. The UF-100 analyzes thefollowing parameters: RBC, WBC,Epithelial Cells, Cast, and Bacteriaand flags the presence of thefollowing: Pathologic Cast, Crystal,Yeast like cell, Sperm and SmallRound Cell.	The Sysmex® UF-100i is anautomated urine cell analyzer forin vitro diagnostic use in screeningpatient populations found inclinical laboratories. The UF-100ianalyzes the following parametersin urine samples: RBC, WBC,Epithelial Cells, Cast, and Bacteriaand flags the presence of thefollowing: Pathologic Cast, Crystal,Sperm, Small Round Cell, Yeast likecell.
Methodology	The UF-100 uses the technique offlow cytometry measuring forwardscatter and fluorescence andimpedance.	The UF-100i uses the samemethodology as the UF-100.
Reagents	URINOSHEATHURINOSEARCHURINOPACK	The UF-100i uses the same reagentsas the UF-100.
Software/HardwareDifferences	---	New front upper cover and hinge, nolaser transformer, screen and labelingchanges.
Specimen Type	Random urine sample	Same as UF-100
Accuracy	Performance was established in theprevious 510(k) submission.	Comparison to the UF-100demonstrated excellent correlation.

Comparison Table to Predicate Method

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

JAN 4 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nina M. Gamperling Manager, Regulatory Affairs Sysmex American, Inc. One Nelson C. White Parkway Mundelein, IL 60060

Re: K053135

Trade/Device Name: Sysmex® UF-100i, Automated Urine Cell Analyzer Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: November 04, 2005 Received: November 08, 2005

Dear Ms. Gamperling:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

K053135 510(k) Number (if known):

Device Name: Sysmex® UF-100i, Automated Urine Cell Analyzer

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CHRD, Office of Device Evaluation (ODE)

Prescription Use X

Over-The-Counter Use

Robert L. Beckerf
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 11

Sysmex UF-100i, Automated Urine Cell Analyzer
510(k) FDA Submission

510(k) <053/35

Regulation Number and Section

§ 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).