(66 days)
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby- Bauer). Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Use of HardyDisk™ AST Rezafungin 5ug (RZF5) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Rezafungin.
HardyDisk™ AST Rezafungin at concentration 5ug can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro. Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis.
Not Found
This is a 510(k) premarket notification for a medical device called HardyDisk™ AST Rezafungin 5ug (RZF5), which is an antimicrobial susceptibility test disc. The document states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.
The acceptance criteria and study information are not directly about an AI/ML device, but rather about an antimicrobial susceptibility test. Therefore, many of the requested points, such as those related to AI assistance, human readers, experts, and adjudication methods, are not applicable.
Here's the relevant information that can be extracted from the provided text, adapted for the context of an antimicrobial susceptibility test:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria and reported device performance. It states that the device "can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro. Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis."
To determine the device's performance, one would typically compare the zone diameters obtained using the HardyDisk™ AST Rezafungin 5ug (RZF5) with a reference method (e.g., broth microdilution method) and evaluate criteria such as essential agreement (EA) and categorical agreement (CA). These specific performance metrics and their acceptance thresholds are not detailed in this particular document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. For an antimicrobial susceptibility test, the sample size would refer to the number of bacterial or fungal isolates tested, and provenance would include details about where these isolates were obtained and if the study was prospective or retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable in the traditional sense for an antimicrobial susceptibility test. The "ground truth" for AST is typically established by a reference method (e.g., CLSI broth microdilution) rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for an antimicrobial susceptibility test in the context of expert adjudication. Adjudication typically applies to ambiguous cases requiring human interpretation.
5. 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 information is not applicable as this is not an AI-assisted device and does not involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI/ML algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an antimicrobial susceptibility test, the "ground truth" for determining susceptibility or resistance of a microorganism to an antimicrobial agent is typically established by reference methods, such as the broth microdilution method according to a recognized standard (e.g., Clinical and Laboratory Standards Institute (CLSI) guidelines). This is inferred from the nature of the device, although not explicitly stated in the document.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML algorithm-based device that undergoes training.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML algorithm-based device that undergoes training.
§ 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).