(43 days)
The MTS (MIC Test Strip) Gentamicin 0.016-256 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined 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.
MTS Gentamicin at concentrations of 0.016-256 uq/mL should be interpreted at 16-20 hours of incubation.
MTS Gentamicin can be used to determine the MIC of gentamicin aqainst the following bacteria. Gentamicin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:
- Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens
MTS consists of specialized paper impregnated with a pre-defined 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 provided text is a 510(k) premarket notification letter and the Indications for Use statement for the MTS Gentamicin 0.016-256 ug/mL device, which is an antimicrobial susceptibility test. This type of device is for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent against bacteria.
Based on the document, I can provide information on acceptance criteria and device performance from the perspective of an antimicrobial susceptibility test, but not a device that utilizes AI or human-in-the-loop performance, as those concepts are not applicable to this product.
Here's the breakdown of the information that can be extracted or reasonably inferred, and where the document is silent on aspects requested in the prompt:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the manner typically found in a clinical study report for an AI/ML device. However, for antimicrobial susceptibility tests like this, the "acceptance criteria" are generally based on the agreement rates with a reference method (e.g., broth microdilution) and the performance against established quality control (QC) ranges for specific organisms. The "reported device performance" would be these agreement rates and successful QC results.
Given the nature of the device, the following would be the high-level performance expectations:
| Metric | Acceptance Criteria (Inferred from AST standards) | Reported Device Performance (Not explicitly in document, but would be expected to meet these for clearance) |
|---|---|---|
| Essential Agreement (EA) | Typically ≥ 90% (agreement within ±1 doubling dilution of reference method) | Not explicitly stated in this document |
| Category Agreement (CA) | Typically ≥ 90% (agreement on Susceptible, Intermediate, Resistant categories) | Not explicitly stated in this document |
| Major Errors (ME) | Typically ≤ 3% (False Susceptible) | Not explicitly stated in this document |
| Very Major Errors (VME) | Typically ≤ 1.5% (False Resistant) | Not explicitly stated in this document |
| Quality Control (QC) Performance | Must fall within established CLSI (Clinical and Laboratory Standards Institute) or equivalent ranges for designated QC strains. | Not explicitly stated in this document, but successful QC is a prerequisite |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set (i.e., the number of bacterial isolates tested). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). For such devices, clinical performance data would typically involve testing a large and diverse collection of clinical isolates, often from multiple geographical locations and collected prospectively or retrospectively from clinical laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. For antimicrobial susceptibility testing, the concept of "experts" establishing ground truth in the way it's used for AI/ML image interpretation is not relevant. The "ground truth" (or reference method) for MIC determination is typically established by carefully performed and validated laboratory methods, most commonly broth microdilution, followed by interpretation based on established clinical breakpoints set by organizations like CLSI or FDA.
4. Adjudication method for the test set
This information is not applicable and not provided in the document. As stated above, the "ground truth" is determined by a reference laboratory method, not by human adjudication of interpretations.
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 is not applicable as the device is an antimicrobial susceptibility test strip, not an AI-assisted diagnostic device requiring human interpretation. Therefore, no MRMC study or effect size related to AI assistance would be performed or reported for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical test strip that is manually read. There is no algorithm involved in its direct operation or interpretation for a standalone evaluation. The "human-in-the-loop" aspect exists in the manual reading of the inhibition zone and subsequent interpretation based on breakpoints.
7. The type of ground truth used
The type of ground truth used for evaluating this device would be the Minimum Inhibitory Concentration (MIC) values determined by a reference method, most commonly broth microdilution, which is considered the gold standard for antimicrobial susceptibility testing. Clinical breakpoints (Susceptible, Intermediate, Resistant categories) are then applied to these MICs.
8. The sample size for the training set
The concept of a "training set" is not applicable to this device, as it is a physical diagnostic test, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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March 22, 2019
Liofilchem s. r. l. % Anne Windau Supervisor Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145
Re: K190252
Trade/Device Name: MTS Gentamicin 0.016 - 256 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: February 6, 2019 Received: February 7, 2019
Dear Anne Windau:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Steven R. Gitterman -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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Indications for Use
510(k) Number (if known) K190252
Device Name
MTS Gentamicin 0.016-256 µg/mL
Indications for Use (Describe)
The MTS (MIC Test Strip) Gentamicin 0.016-256 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined 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.
MTS Gentamicin at concentrations of 0.016-256 uq/mL should be interpreted at 16-20 hours of incubation.
MTS Gentamicin can be used to determine the MIC of gentamicin aqainst the following bacteria. Gentamicin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:
- Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens
| 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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§ 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).