The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The purpose of this 510(k) is specifically for the ceftolozane/tazobactam MTS at concentrations of 0.016/4 - 256/4 mcg/mL.

Ceftolozane/azobactam has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label:

Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Device Description

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

AI/ML Overview

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the "Liofilchem MIC Test Strip (MTS) - Ceftolozane/tazobactam." It does not contain the detailed information required to answer your questions about acceptance criteria for an AI/ML device study.

Specifically, the document pertains to an in vitro diagnostic device (MTS) used for antimicrobial susceptibility testing, which involves manual reading procedures and overnight incubation. It's a standard microbiological test, not an AI/ML powered device.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML model. It's about substantial equivalence to a predicate device for a manual test strip.
Sample sizes used for the test set and the data provenance: Not applicable to an AI/ML study description in this document.
Number of experts used to establish the ground truth...: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The device involves manual reading, not AI assistance for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, ground truth would be established by standard microbiological methods (e.g., broth microdilution reference method) to determine the true MIC value, but the details of such a comparative study are not in this letter.
The sample size for the training set: Not applicable, as this is not an AI/ML training dataset.
How the ground truth for the training set was established: Not applicable.

The document discusses the "Indications for Use" for the test strip and lists bacteria against which the antibiotic combination (ceftolozane/tazobactam) has shown activity "both clinically and in vitro according to the FDA label." This refers to the established efficacy of the drug, not the performance metrics of an AI/ML diagnostic alongside a reader.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 12, 2016

LIOFILCHEM s.r.l. C/O LAURA KOETH LABORATORY SPECIALISTS, INC. 1651-A CROSSINGS PARKWAY WESTLAKE, OH 44145

Re: K161175

Trade/Device Name: Liofilchem MIC Test Strip (MTS) - Ceftolozane/tazobactam 0.016/4 -256/4 mcg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY Dated: April 18, 2016 Received: April 26, 2016

Dear Ms. Koeth:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ribhi Shawar -S

For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161175

Device Name

Liofilchem MIC Test Strip (MTS) - Ceftolozane/tazobactam 0.016/4 - 256/4 mcg/mL

Indications for Use (Describe)

The purpose of this 510(k) is specifically for the ceftolozane/tazobactam MTS at concentrations of 0.016/4 - 256/4 mcg/mL.

Ceftolozane/azobactam has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label:

Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

7 Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).