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. gonorrhoeae ). 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 (MC) in ye/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The indications for use of this 510(k) is specifically for the Ceftazidime MTS at concentrations of 0.016 - 256.0 ug/mL interpreted after 16-20 hours of incubation.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Ceftazidime according to the FDA label are:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris 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 (MC) in ye/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0μg/mL". This device is an antimicrobial susceptibility test. However, the document provided does not contain the detailed study information required to answer all parts of your request. It mainly describes the regulatory approval process and the indications for use of the device.

Therefore, I can only provide limited information based on the text.

Here's what I can extract:

A table of acceptance criteria and the reported device performance
- The document does not provide a table of acceptance criteria or reported device performance for this specific device. This information would typically be found in the detailed study report submitted as part of the 510(k), which is not included here.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not present in the provided text.
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 present in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not present in the provided text.
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
- The Liofilchem MIC Test Strip (MTS) is a manual reading device, not an AI-assisted device. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable, and this information is not present.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device involves manual reading, so it's not a standalone algorithm. This information is not present.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For antimicrobial susceptibility tests, the "ground truth" often refers to a reference method (e.g., broth microdilution or agar dilution) against which the test strip's results are compared. The document states "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 µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures." It does not explicitly state the specific reference method used for ground truth comparison in validation studies.
The sample size for the training set
- This information is not present in the provided text. As a manual test strip, it generally doesn't involve a "training set" in the machine learning sense.
How the ground truth for the training set was established
- This information is not present in the provided text. Again, the concept of a "training set" with established ground truth is typically associated with AI/machine learning models, which this device is not.

Summary

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

February 22, 2017

LIOFILCHEM S. R. L. LAURA KOETH PRESIDENT, LABORATORY SPECIALISTS, INC 1651-A CROSSINGS PARKWAY WESTLAKE OH 44145

Re: K163298

Trade/Device Name: Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0μg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY Dated: November 21, 2016 Received: December 6, 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 (QS) 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/Resourcesfor You/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 -A

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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Indications for Use

510(k) Number (if known)

K163298

Device Name

Liofilchem MIC Test Strip (MTS) Ceftazidime (CAZ) 0.016-256.0 ug/mL

Indications for Use (Describe)

The indications for use of this 510(k) is specifically for the Ceftazidime MTS at concentrations of 0.016 - 256.0 ug/mL interpreted after 16-20 hours of incubation.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Ceftazidime according to the FDA label are:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa

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

Prescription Use (Part 21 CFR 801 Subpart D)
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).