(25 days)
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae.
Oxoid Lomefloxacin Susceptibility Test Disc
This document is a 510(k) clearance letter from the FDA for a medical device, specifically the Oxoid Lomefloxacin Antimicrobial Susceptibility Test Disc. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the detailed study information required to answer your request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria." The letter is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" for the indications for use, but it doesn't describe the studies that led to that determination, nor does it list specific performance criteria or results.
Therefore, most of the information requested in your prompt cannot be extracted from this document.
Here's what can be inferred or stated based on the document's content:
- Device Name: Oxoid Lomefloxacin Susceptibility Test Disc
- Indication for Use: For the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms, including Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae.
- Regulatory Class: II
- Product Code: JTN
- Type of Device: Antimicrobial Susceptibility Test Disc
Information NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The letter indicates substantial equivalence, implying general performance parity with predicate devices, but doesn't list specific metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- 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 device is an antimicrobial susceptibility test disc, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical test disc and not an algorithm.
- The type of ground truth used: Not explicitly stated, but for antimicrobial susceptibility testing, the ground truth typically involves reference broth microdilution methods (e.g., CLSI breakpoints) or other established laboratory methods. This would have been part of the underlying data submitted for the 510(k).
- The sample size for the training set: Not applicable and not present, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable and not present.
To obtain the detailed study information you're looking for, you would need to access the full 510(k) submission (K973488) which would contain the preclinical and clinical data submitted by Oxoid Limited to the FDA.
§ 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).