(42 days)
Tigecycline is indicated for Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and by modified procedures Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pnemoniae.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device: "Tigecycline Antimicrobial Susceptibility Test Disc." This document is a clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. It is a regulatory clearance document, not a scientific study report.
Therefore, I cannot provide the requested information from the given text.
To be clear:
- A table of acceptance criteria and the reported device performance: Not available in the provided text.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available (this device is a physical test disc, not an algorithm).
- The type of ground truth used: Not available.
- The sample size for the training set: Not available (training set would not be applicable in the typical sense for this device).
- How the ground truth for the training set was established: Not available.
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).