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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) SUMMARY of the UF-500i

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: _________________________________________________________________________________________

1. Submitted by:	Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: October 3, 2008
2. Name of Device:	Trade or proprietary name: Sysmex® UF-500iCommon name: Automated urine particle analyzer.Classification name:Urine Particle Counter (21 CFR 864.5200, Product Code LKM)Related Items:Sheath: UFII SHEATH (Product code: GIF)Stain: UFII SEARCH -SED (Product code: GJH)Diluent: UFII PACK -SED (Product code: GIF)Stain: UFII SEARCH -BAC (Product code: GJH)Diluent: UFII PACK -BAC (Product code: GIF)QC Material: UFII CONTROL (Product code: JIW)Calibrator: UFII CALIBRATOR (Product code: JJW)Option:Graph printerBar code ReaderRack Sampler Unit (UASU-3/UASU-4)PU-17
3. Predicate Method:	Sysmex® UF-1000i (k#070910-Cleared May 25, 2007)
4. Device Description:	The Sysmex® UF-500i, an automated urine particle analyzer, is adedicated system for the analysis of microscopic formed elements inurine 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 theMain Unit and provides the operator interface with the system. The UF-500i is equipped with a Sampler that provides continuous automatedsampling for up to 60 tubes.The instrument utilizes Sysmex flow cytometry using a redsemiconductor laser for analyzing organized elements of urine. Particlecharacterization and identification is based on detection of forwardscatter, fluorescence and adaptive cluster analysis. Using its ownreagents, the UF-500i automatically classifies organized elements ofurine and carries out all processes automatically from aspiration of thesample to outputting the results.Analysis results and graphics are displayed on the IPU screen. Theycan be printed on any of the available printers or transmitted to a Host
	computer.
5. Intended Use:	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.
6. Substantial equivalence-Similarities and Differences:	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.
7. Conclusion	The UF-500i demonstrates substantial equivalence to the predicate device, the UF-1000i.

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Special 510(k) UF-500i, Automated Urine Particle Analyzer

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September 1999 by 1999

and the comments of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sysmex America, Inc. c/o Ms. Nina Gamperling Director Clinical Affairs One Nelson C. White Parkway Mundelein. IL 60060

FR - 3 2009

Re: K083002

Trade/Device Name: Sysmex® UF-500i Automated Urine Particle Analyzer Regulation Number: 21 CFR 864.5200 Regulation Name: Automated Cell Counter Regulatory Class: Class II Product Code: LKM Dated: January 05, 2009 Received: January 06, 2009

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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Page 2 - Ms. Nina Gamperling

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ie m. chan

Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K083002

Device Name: Sysmex® UF-500i, Automated Urine Particle Analyzer

Indications For Use: 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHI PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (3RE) off

Office of In Vitro Diagnostic Device Evaluation and Safety

Special 510(k) UF-500i, Automated Urine Particle Analyzer

510(k) K083082 10

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).