The Dade Behring LabPro AlertEx Software System is intended for use with the LabPro Data Management System Software, version 3.0 and MicroScan® Instruments (e.g., WalkAway SZ, autoSCAN-4). The Alertex Software notifies the user of unusual conditions, or out-of-range results that may warrant further analysis or action, and/or provides the user with the ability to change organism identifications and/or antibiotic susceptibility test interpretations.

Device Description

The Dade Behring LabPro AlertEx Software System is a rule-based software application within the LabPro Data Management System Software version 3.0. The initial LabPro software releases (prior to version 3.0) contained Alert functionality that automatically notified the user of unusual conditions or out-of-range results that may warrant further analysis or action. The LabPro Alertex software offers added functionality including the ability to change the organism identification (ID) and/or antimicrobial susceptibility testing (AST) interpretations.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It mainly focuses on the regulatory submission and approval of the Dade Behring LabPro AlertEx Software System, stating its intended use and substantial equivalence to a predicate device.

Here's an analysis of what information is available and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided documents. The text mentions "The LabPro AlertEx Software Verification and Validation Testing confirmed that the AlertEx software operates in accordance with the intended functional requirements." This implies that there were functional requirements acting as acceptance criteria, but their specific details (e.g., specific accuracy thresholds, alert rates) are not provided.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, alert rates for different scenarios) are reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

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)

This information is not provided in the given text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text.

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

This information is not provided. The device is described as a "rule-based software system" that notifies users and allows for changes in interpretations, implying a human-in-the-loop system. However, no comparative effectiveness study on human reader improvement is mentioned.

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

The text describes the software's function to "notify the user of unusual conditions" and "provide the user with the ability to change organism identifications and/or antibiotic susceptibility test interpretations." This indicates it is designed to work with a human user, not as a standalone diagnostic tool without human oversight. There is no mention of standalone performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided in the given text.

8. The sample size for the training set

This information is not provided in the given text. As a "rule-based software system," it might not involve traditional machine learning training sets in the same way a deep learning AI would. Its "rules" would likely be derived from expert knowledge and clinical guidelines.

9. How the ground truth for the training set was established

This information is not provided in the given text.

Summary of available information regarding the "study" and "acceptance criteria":

The submission mentions "software development and verification and validation testing processes."
It states that "The LabPro AlertEx Software Verification and Validation Testing confirmed that the AlertEx software operates in accordance with the intended functional requirements."
The comparison is primarily focused on substantial equivalence to a predicate device (BDXpert System) as defined in a specific FDA guidance document for AST systems. This implies that the 'acceptance criteria' for regulatory approval were met through demonstrating equivalence based on the guidance document, rather than specific performance metrics reported here.

In conclusion, the provided FDA 510(k) summary and approval letter focus on the regulatory process and substantial equivalence, but do not disclose the detailed technical performance study results, acceptance criteria, or methodological specifics (like sample sizes, expert qualifications, or ground truth establishment) that would typically be found in a detailed device performance study report.

Summary

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K070346

JUL 18 2007

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Robert Eusebio, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	February 2, 2007
Product Name:	Microbiology rule-based software system
Trade Name:	Dade Behring LabPro AlertEx Software System
Intended Use:	To notify the user of unusual conditions, or out-of-range resultsthat may warrant further analysis or action and/or to provide theuser with the ability to change organism identifications and/orantibiotic susceptibility test interpretations.
510(k) Notification:	New microbiology rule-based software system – DadeBehring LabPro AlertEx Software System
Predicate device:	BDXpert System resident on the EpiCenter System(K040099)

510(k) Summary:

The proposed LabPro AlertEx Software System substantially equivalent to the BDXpert System resident on the EpiCenter System, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. The Premarket Notification (510[k]) presents the software development and verification and validation testing processes used for the LabPro Alertex Software.

The LabPro AlertEx Software Verification and Validation Testing confirmed that the AlertEx software operates in accordance with the intended functional requirements.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract design of an eagle with three lines representing its wings and three curved lines below, possibly representing water or waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 8 2007

Mr. Robert Eusebio Regulatory Affairs Specialist Dade Behring, Inc. 2040 Enterprise Blvd West Sacramento, CA 95691

Re: K070346

Trade/Device Name: Dade Behring LabPro AlertEx Software System Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short Term Incubation Cycle Antimicrobial Susceptibility Device Regulatory Class: Class II Product Code: LON

Dated: July 9, 2007 Received: July 10, 2007

Dear Mr. Eusebio:

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).

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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.

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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Sally, autum

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology 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): ڀلام ڪيو

Device Name: Dade Behring LabPro AlertEx Software System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) · AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

fall atsm
Division Sign-Off

Division Sign-Off

Office of In Vitro Dlagno Device Evaluation and Safety

510(k) K070246

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Alert 510k final.doc

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”