The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the results of susceptibility tests in other media can be keved in manually.

The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated results reports, reqularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results.

In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates: compares patient histories: classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics.

SIRSCAN can be connected to any laboratory management system, as well as to some micro-dilution systems (e.g., Vitek™, Microscan™).

Device Description

SIRSCAN is an automatic reader of petri dishes that is used to manage overall susceptibility tests. The SIRSCAN is an automated susceptibility reader and interpretation system. It consists of two components:

(1) The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the results of susceptibility tests in other media can be keyed in manually.

(2) The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated results reports, regularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results.

In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates; compares patient histories; classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics.

SIRSCAN can be connected to any laboratory management system, and to some micro-dilution systems (e.g., VitekTM, MicroscanTM).

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SIRSCAN (Automatic Zone Reader)

Intended Use: Management of overall susceptibility tests for Enterobacteriaceae, staphylococci (excluding coagulase-negative staphylococci with weak growth), and non-fermenting gram-negative bacilli (excluding strains with weak growth).

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria for the SIRSCAN device. Instead, the "Performance Data" section refers to a single study, and the "CONCLUSIONS" state that "the performance data provide reasonable assurance of the safety and effectiveness of SIRSCAN for its proposed indications for use." This suggests the acceptance was based on the overall findings of the study meeting the requirements for substantial equivalence to predicate devices, rather than predefined numeric thresholds for metrics like accuracy or precision.

However, based on the device's function (reading zones in Kirby-Bauer disk diffusion tests), one can infer the intent of the performance evaluation. The study would have aimed to demonstrate that SIRSCAN's automated readings were comparable to a recognized standard (likely manual expert readings). Without explicit quantitative criteria, we can only report the existence of the study as the proof of performance.

Acceptance Criteria (Inferred)	Reported Device Performance
Device provides accurate and reliable zone diameter readings for susceptibility tests.	The cited study, "Evaluation of the SIRSCAN Automated Zone Reader in a Clinical Microbiology Laboratory" by Medeiros, A. and Crellin, J., Brown University (1998), concluded that the performance data provides "reasonable assurance of the safety and effectiveness of SIRSCAN for its proposed indications for use" and that it is "substantially equivalent to the claimed predicates under conditions of intended use." Specific quantitative performance metrics (e.g., accuracy percentages, sensitivity, specificity, reproducibility, or agreement with manual readings) are not detailed in the provided summary. However, the FDA's clearance (K991473) implies that these requirements were met based on the full submission including the study.
Device accurately interprets susceptibility test results based on NCCLS M2-A6 guidelines.	(See above)
Device effectively manages and compiles data from NCCLS agar disk diffusion tests.	(See above)
Device's expert system feature provides consistency checks for validation of tests and results.	(See above)
Device performs other stated functions (calculating MICs, QC, epidemiology, etc.) accurately.	(See above)
Device is substantially equivalent to legally marketed predicate devices.	The FDA concluded that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

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

Sample Size (Test Set): The provided text does not specify the sample size (number of petri dishes, organisms, or strains) used in the "Evaluation of the SIRSCAN Automated Zone Reader in a Clinical Microbiology Laboratory" study.
Data Provenance: The study was conducted at Brown University by Medeiros, A. and Crellin, J. (1998). The text does not explicitly state whether the data was retrospective or prospective, or the country of origin of the samples themselves, but its association with Brown University suggests a U.S.-based clinical laboratory setting.

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

The provided text does not specify the number of experts used or their qualifications for establishing ground truth in the study. In the context of Kirby-Bauer disk diffusion, ground truth for zone diameters would typically be established by experienced microbiologists performing manual measurements.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The provided text does not indicate that an MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The study described focuses on the evaluation of the SIRSCAN device itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The SIRSCAN device is inherently an automated system designed to read zone diameters and interpret results without a human performing the initial measurements. Therefore, the evaluation of SIRSCAN itself, as described, is a standalone (algorithm-only) performance assessment in the context of its primary function (automated reading). The system does include data management and an expert system feature for consistency checks, indicating an "algorithm-only" performance for the measurement and initial interpretation stages.

7. The Type of Ground Truth Used

While not explicitly stated, for a device reading and interpreting Kirby-Bauer disk diffusion zones, the ground truth would most likely be established by expert consensus (i.e., manual measurements and interpretations by experienced clinical microbiologists) using the NCCLS M2-A6 standard.

8. The Sample Size for the Training Set

The provided text does not specify any training set sample size. This type of device, which performs image analysis to measure zones against a known standard (NCCLS M2-A6), might not have a "training set" in the modern machine learning sense requiring a large pre-labeled dataset. Instead, its algorithm would likely be based on established image processing techniques and calibrated to the physical dimensions and expected characteristics of inhibition zones. If any trainable components were present, their training data is not mentioned.

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

Since a specific "training set" and its sample size are not mentioned, the method for establishing its ground truth is also not provided.

Summary

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APPENDIX H

510(k) SUMMARY i2a Corporation SIRSCAN

This 510(k) summary of safety and effectiveness for SIRSCAN is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	i2a Corporation (Intelligence Artificielle Applications)
Address:	Parc de la MéditerranéeBP 4234470 PEROLS CedexFRANCE
Contact Person:	Mr. Jean-Philippe Duverge, Managing Director
Telephone:	011-33-467-504-800
Preparation Date:	June 1998
Device Trade Name:	SIRSCAN™
Common Name:	Automatic Zone Reader
Classification Name:	Automated Zone Reader (see 21 C.F.R. § 866.2850)Product Code: KZK
Device Description:	SIRSCAN is an automatic reader of petri dishes that is usedto manage overall susceptibility tests. The SIRSCAN is anautomated susceptibility reader and interpretation system. Itconsists of two components:
	(1) The SIRSCAN automated zone reader device is avideo-camera image analysis computer-based system toread susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms:enterobacteriacae; staphylococci, (except coagulasenegative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weakgrowth). Other susceptibility tests on solid medium are readwith the electronic caliper, and the results of susceptibilitytests in other media can be keyed in manually.

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	(2) The SIRSCAN data management system compiles datafrom the NCCLS agar disk diffusion test. It prints, files andproduces integrated results reports, regularly or on request,to be used by clinicians, bacteriologists and epidemiologists.Its expert system feature offers consistency checks forvalidation of tests and results.
	In addition, the SIRSCAN data management system:interprets zones; calculates MICs; provides qualitycontrol and epidemiology and infection control;identifies and eliminates duplicates; compares patienthistories; classifies and monitors resistancephenotypes; monitors multi-resistant organisms;detects and monitors nosocomial infections; andprepares epidemiological statistics.
	SIRSCAN can be connected to any laboratory managementsystem, and to some micro-dilution systems (e.g., VitekTM,MicroscanTM).
Intended Use:	SIRSCAN is intended for the management of overall
	susceptibility tests for the following organisms:
	Enterobacteriacae, staphylococci (expert coagulase negative
	staphylococci with weak growth), and non-fermenting gram
	negative bacilli (except strains with weak growth).
Performance Data:	Medeiros, A. And Crellin, J., Evaluation of the SIRSCANAutomated Zone Reader in a Clinical MicrobiologyLaboratory, Brown University (1998). See Appendix C.
CONCLUSIONS:	Based on the foregoing and other information in this
	application, i2a Corporation believes that the performance
	data provide reasonable assurance of the safety and
	effectiveness of SIRSCAN for its proposed indications for
	use. Further, SIRSCAN is substantially equivalent to the
	claimed predicates under conditions of intended use.

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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 top half of the circle. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting unity and cooperation.

NOV 23 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Intelligence Artificielle Applications (i2a) Corp. Mr. Marc J. Scheineson, Esq. c/o Reed Smith Shaw & McClay 1301 K Street, N.W. Suite 1100 - East Tower Washington, D.C. 20005-3317

K991473 Re: Trade Name: SIRSCANTM Regulatory Class: II Product Code: KZK Dated: September 27, 1999 Received: September 28, 1999

Dear Mr. Scheineson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX C

LABELING/INDICATIONS FOR USE

Application Number (if known): _______________________________________________________________________________________________________________________________________________

Device Name: SIRSCAN

Indications For Use:

SIRSCAN can be connected to any laboratory management system, as well as to some micro-dilution systems (e.g., Vitek™, Microscan™).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 C.F.R. 801.109)

Over-the-Counter Use

Woody Dubois

ision of Clinical Laboratory Devices 510(k) Number_1(991473

Regulation Number and Section

§ 866.2850 Automated zone reader.

(a)
Identification. An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.(b)
Classification. Class I (general controls).