(60 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram neqative orqanisms. This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.002 - 16 ug/ml for testing gram positive and 0.002 - 4 ug/ml for testing gram negative isolates to the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance of Gemifloxacin is for: Klebsiella pneumonia. Gemifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of (0.25ug/mL) or less against most (≥90%) of the following microorganisms: however, the safety and effectiveness of gemifloxacin in treating clinical infections due to these microorganisms has not been established in adequate and wellcontrolled clinical trials. Staphylococcus aureus (Methicillin-susceptible strains only) Streptococcus pyogenes Acinetobacter Iwoffi Klebsiella oxytoca Proteus vulgaris.
Susceptibility Test Panel for Gemifloxacin 0.002-4μg/ml Gram Negative Susceptibility Test Panel for Gemifloxacin 0.002-16ug/ml Gram Positive
This document is a 510(k) clearance letter for an antimicrobial susceptibility test panel. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a legally marketed predicate device.
However, the provided text DOES NOT contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the comprehensive study details you've requested.
The document states that the FDA has "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent...". This implies that the applicant (TREK Diagnostic Systems, Inc.) submitted data and information to support their claims. However, this specific letter does not present that data, nor does it lay out the acceptance criteria used by the FDA for making its determination.
Therefore, I cannot provide the information you requested based on the given text.
To answer your questions, one would need access to the full 510(k) submission (K053243) from TREK Diagnostic Systems, Inc., which would contain the study protocols, raw data, analysis, and stated acceptance criteria.
Based on the provided text, the following aspects are completely unknown:
- Acceptance Criteria Table: Not present.
- Reported Device Performance: Only the claimed MIC ranges are mentioned for Gemifloxacin, but no performance metrics (e.g., accuracy, sensitivity, specificity, or categorical agreement) are given.
- Sample Size (Test Set): Not mentioned.
- Data Provenance (Test Set): Not mentioned.
- Number of Experts (Ground Truth): Not mentioned.
- Qualifications of Experts (Ground Truth): Not mentioned.
- Adjudication method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned as being performed for this particular 510(k). This type of study is more common for imaging AI devices rather than AST panels.
- Effect size of human reader improvement: Not applicable given the type of device and lack of MRMC study description.
- Standalone (algorithm only) performance: This device is a manual or semi-automated system for reading MICs, so the concept of an "algorithm only" performance as typically applied to image-based AI would not directly apply without further context on how "standalone" would be interpreted for an AST panel. However, the study would have involved comparing the device's readings to a reference method (the "ground truth").
- Type of Ground Truth: While it can be inferred that the ground truth for an AST panel would be a reference AST method (e.g., broth microdilution or agar dilution as established by CLSI), the specific method used is not detailed in this document.
- Sample Size (Training Set): Not mentioned.
- Ground Truth for Training Set: Not mentioned.
In summary, this document is a regulatory approval letter, not a scientific study report or a detailed summary of the performance data submitted for approval.
§ 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).