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K Number
K170772
Device Name
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
Manufacturer
Liofilchem s.r.l.
Date Cleared
2017-06-07

(85 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
Microbiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Liofilchem® MIC Test Strip (MTS) 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 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 Clindamycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.

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

Staphylococcus aureus (methicillin-susceptible strains)

Device Description

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent.

AI/ML Overview

I am sorry, but the provided text describes an FDA 510(k) premarket notification for an antimicrobial susceptibility test strip (Liofilchem MIC Test Strip, Clindamycin). This document is a regulatory approval letter and does not contain the detailed study information needed to answer your questions about acceptance criteria and device performance in the context of an AI/machine learning study.

The document discusses:

  • The device: Liofilchem MIC Test Strip (MTS), Clindamycin 0.016 - 256μg/mL
  • Its purpose: In vitro determination of antimicrobial susceptibility of bacteria.
  • Regulation and product codes.
  • General controls provisions for marketed devices.
  • Indications for Use: Specifically for Staphylococcus aureus (methicillin-susceptible strains) against Clindamycin, with incubation and manual reading procedures.

It does not include any information about:

  • A table of acceptance criteria or reported device performance for an AI/ML system.
  • Sample sizes for test or training sets related to an AI/ML model.
  • Data provenance (e.g., country of origin, retrospective/prospective).
  • Number or qualifications of experts used to establish ground truth for AI/ML.
  • Adjudication methods for AI/ML test sets.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies with AI assistance.
  • Standalone algorithm performance.
  • Type of ground truth (e.g., pathology, outcomes data) for an AI/ML study.
  • How ground truth was established for training sets in an AI/ML context.

Therefore, I cannot provide an answer that meets your requirements based on the given input.

§ 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).