The XE-2000 and XT-Series are automated hematology analyzers previously cleared by the FDA. The XS performs hematology analyses using the following methods: Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study proving the device meets them:

The document provided, a 510(k) summary for the Sysmex® XS, Automated Hematology Analyzer, primarily focuses on demonstrating substantial equivalence to predicate devices (Sysmex XE-2100 and Sysmex XT-Series). As such, the information regarding specific acceptance criteria and the detailed study proving the device meets them is limited and presented indirectly through the comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state a table of acceptance criteria in numerical targets for metrics like accuracy, sensitivity, or specificity. Instead, the performance is demonstrated by showing "excellent correlation" to the predicate devices. The acceptance criterion is implicitly that the Sysmex XS performs comparably to the already cleared predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Performance equivalent to predicate devices (Sysmex XE-2100 and XT-Series) for hematology analysis (Intended Use)	"Comparison to the XE-2100 and XT-Series analysers demonstrated excellent correlation."
Methodology using Sheath Flow DC Detection, Flow Cytometry with Semiconductor Laser, and SLS-hemoglobin method.	The XS uses Sheath Flow DC Detection Method, Flow Cytometry Methods using a Semiconductor Laser and SLS-hemoglobin method, which is similar to the predicate.
Use with EDTA anticoagulant.	The XS uses EDTA, same as the predicate.
Use with peripheral blood specimens.	The XS uses peripheral blood, same as the predicate.
Intended for in vitro diagnostic use in clinical laboratories.	The Sysmex® XS-Series is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample size (number of patient samples) used for the comparison studies. It only states, "Studies were performed to evaluate the equivalency of XS to the predicate method."
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not explicitly mention the use of human experts to establish ground truth in the context of this 510(k) submission. For hematology analyzers, "ground truth" for parameters like cell counts and differentials is typically established by the predicate device's measurements, or by well-established reference methods and manual microscopy (which would require trained experts). Given the nature of a substantial equivalence claim for an automated analyzer, the primary comparison would be to the output of the predicate device.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method as it relates to expert consensus or discrepancies. The comparison is between the new device's output and the predicate device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The Sysmex XS is an automated hematology analyzer, meaning it provides objective measurements without human interpretation in the primary analysis loop. Therefore, there is no "human reader" component to improve "with AI vs without AI assistance." The stated comparison is between the new automated device and existing automated predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, implicitly, a standalone performance evaluation was done. As an automated analyzer, the Sysmex XS operates "algorithm only" without human intervention for its core measurement functions. The performance evaluation involved comparing its output directly to the output of other automated analyzers (the predicates).

7. The Type of Ground Truth Used:

The primary "ground truth" for the comparison studies was implicitly the measurements and classifications provided by the legally marketed predicate devices (Sysmex XE-2100 and Sysmex XT-Series). The document states: "Comparison to the XE-2100 and XT-Series analysers demonstrated excellent correlation."

8. The Sample Size for the Training Set:

The document does not specify a training set sample size. For an automated hematology analyzer, the "training" (calibration, algorithm development) would have occurred during the device's development phase, prior to this 510(k) submission seeking market clearance by demonstrating equivalence. The studies mentioned here are typically verification and validation studies on an already developed and potentially "trained" system.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide information on how the ground truth for any internal training data was established. This information would typically be part of the manufacturer's internal design control documentation and not usually detailed in a 510(k) summary, which focuses on demonstrating substantial equivalence for market clearance. It's likely that development would have involved reference methods, spiked samples, and potentially manual microscopy for initial calibration and algorithm refinement.

Summary

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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: HOLOOLO 5 V

1. Submitted by:	Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: March 10, 2006
2. Name of Device:	Trade or proprietary name: Sysmex® XS, AutomatedHematology Analyzer.Common name: XSClassification name: Automated Differential Cell Counter,Sysmex® XS-1000i and XS-800i (21 CFR 864.5220)
3. Predicate Device:	The Sysmex® XS, Automated Hematology Analyzer, issubstantially equivalent to the Sysmex XE-2100 and Sysmex XT-Series, Automated Hematology Analyzers.
4. Device Description:	The XE-2000 and XT-Series are automated hematology analyzerspreviously cleared by the FDA.
5. Intended Use:	The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.
6. Substantialequivalence-similaritiesand differences	The following table compares the XS with the predicate method.

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

Comparison Table to Predicate Method
	Sysmex XE-2100Predicate	Sysmex XS-SeriesNew Instrument
Intended Use	The SysmexTM XE-2100 is a multi-parameter hematology analyzerintended to classify formed elementsin anti-coagulated blood. The XE-2100 can provide accurate and precisetest results for up to 32 analysisparameters in whole blood.	The Sysmex® XS-Series is anautomated hematology analyzer for invitro diagnostic use in clinicallaboratories.
Methodology	The XE-2100 performs hematologyanalyses using the following methods:RF/DC Detection Method, SheathFlow DC Detection Method, FlowCytometry Methods using aSemiconductor Laser and SLS-hemoglobin method.	The XS performs hematologyanalyses using the following methods:Sheath Flow DC Detection Method,Flow Cytometry Methods using aSemiconductor Laser and SLS-hemoglobin method.
Type ofAnticoagulant	EDTA	EDTA
Specimen Type	Peripheral blood	Peripheral blood
Accuracy	Performance was established in theprevious 510(k) submission.	Comparison to the XE-2100 and XT-Series analysers demonstratedexcellent correlation.

Comparison Table to Predicate Method

7. Clinical Performance Data:	Studies were performed to evaluate the equivalency ofXS to the predicate method.
8. Conclusions:	The performance data demonstrated substantialequivalence.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway 1 1 0 2006 Mundelein, Illinois 60060

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K060656

Trade/Device Name: Sysmex® XS, Automated Hematology Analyzer Regulation Number: 21 CFR & 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: March 10, 2006 Received: March 13, 2006

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.

Robert Beckerh

Robert L. Becker, Jr., MD, PH.D 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

KOLOGGE 510(k) Number (if known):_

Device Name: Sysmex® XSTM, Automated Hematology Analyzer

Indications For Use:

The Sysmex® XS is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories.

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

Concurrence of CHRD, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _ fice of In Vitro Diagnostic Device valuation and Safe Sysmex America, Inc. 510(k) XS Submission

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”