(66 days)
HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantiative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae. HardyDisk™ Cefixime is indicated for in vitro activity against the Enterobacteriaceae, Streptococcus spp., Haemophilus spp., Neisseria gonorrhoeae and Moraxella catarrhalis.
HardyDisk™ Cefixime 5mcg is an antimicrobial sensitivity disk.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device, specifically the HardyDisk™ Cefixime 5mcg. This document confirms the device's substantial equivalence to a legally marketed predicate but does not contain the acceptance criteria or a study proving that the device meets those criteria.
The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It does not typically include detailed performance study results or acceptance criteria in the approval letter itself. Such information would be part of the original 510(k) submission, which is not provided here.
Therefore, I cannot extract the requested information from the given text.
To answer your request, I would need access to the actual 510(k) submission document or a summary of its data, which would typically include:
- A table of acceptance criteria and the reported device performance: This would detail the specific metrics used (e.g., inhibition zone diameters, categorical agreement with a reference method) and the thresholds for acceptance (e.g., ±3mm for zone diameter, ≥90% essential agreement).
- Sample size used for the test set and the data provenance: This would describe the number of bacterial isolates tested and if the data was collected retrospectively or prospectively, and from what geographical regions.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For antimicrobial susceptibility testing, the ground truth is typically established by a reference method (e.g., broth microdilution or agar dilution) performed and interpreted by trained microbiologists. "Experts" in this context would refer to these individuals, though their specific qualifications (e.g., "clinical microbiologist with 10 years of experience") are rarely detailed in public summaries.
- Adjudication method for the test set: Not typically applicable for antimicrobial susceptibility testing, as the reference method provides a definitive result.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable for an antimicrobial susceptibility disk, as interpretation is standardized based on zone diameter.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself (an antibiotic disk) is not an algorithm. Its performance is evaluated by measuring inhibition zones.
- The type of ground truth used: For antimicrobial susceptibility testing, the ground truth is typically a reference broth microdilution (BMD) or agar dilution method as standardized by CLSI (Clinical and Laboratory Standards Institute).
- The sample size for the training set: Not applicable for this type of device, which is not an AI/ML algorithm that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
§ 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).