(87 days)
HardyDisk AST disks are used for semi-quantitative 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 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 Gepotidacin 10μg (GEP10) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
HardyDisk AST Gepotidacin at concentration 10μg demonstrated acceptable performance to determine the zone diameter (mm) of gepotidacin against the following microorganisms:
Enterobacterales (Citrobacter freundii complex, Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Klebsiella aerogenes, Klebsiella oxytoca/Raoultella ornithinolytica, Morganella morganii, Proteus mirabilis, Providencia rettgeri)
Enterococcus faecalis
Staphylococcus saprophyticus
Not Found
The provided FDA 510(k) clearance letter is for the HardyDisk AST Gepotidacin 10µg (GEP10), an Antimicrobial Susceptibility Test Disc. This document primarily focuses on the regulatory clearance of a medical device and its intended use, rather than a detailed study report of an AI/ML powered device.
Therefore, the information traditionally sought for acceptance criteria and study proving performance for AI/ML devices (such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this type of FDA clearance letter for a non-AI/ML antimicrobial susceptibility test disk.
The provided document describes:
- Device Name: HardyDisk AST Gepotidacin 10µg (GEP10)
- Intended Use: Semi-quantitative in vitro susceptibility testing by the agar diffusion (Kirby-Bauer) method.
- Acceptable Performance Demonstrated For: Determining the zone diameter (mm) of gepotidacin against specific microorganisms (Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis).
Since this is a traditional in vitro diagnostic device (an antimicrobial susceptibility test disk), its "acceptance criteria" relate to its ability to accurately determine susceptibility based on zone diameters, which is typically validated through comparison to a reference method (e.g., broth microdilution) and established interpretive criteria (STIC). The performance metrics would involve agreement rates (Essential Agreement and Categorical Agreement) with the reference method.
Based on the provided text, I cannot extract the specific details requested regarding study methodology, sample sizes, expert involvement, and ground truth establishment in the context of an AI/ML device. The letter only states that the device "demonstrated acceptable performance."
To answer your request, I will indicate where the information would typically be found in a study report for an AI/ML device and then explain why it's not present in this specific document.
Hypothetical Description of Acceptance Criteria and Study (if this were an AI/ML device, as requested by the prompt, but adapted to the limited information for this non-AI/ML device):
Given that the provided document is a 510(k) clearance letter for an Antimicrobial Susceptibility Test Disc (a traditional IVD, not an AI/ML device), the detailed study information typically associated with AI/ML algorithm validation (e.g., number of experts, adjudication methods, MRMC studies) is not included in this type of regulatory correspondence.
However, for a non-AI/ML device like an AST disk, "acceptance criteria" and "proof of meeting criteria" would typically involve demonstrating:
- Essential Agreement (EA): The percentage of isolates for which the test device's zone diameter measurement is within a certain agreement range (e.g., ±3 mm) of the reference method's MIC or zone diameter.
- Categorical Agreement (CA): The percentage of isolates for which the test device's interpretive result (Susceptible, Intermediate, Resistant) matches the reference method's interpretive result based on established breakpoints.
- Very Major Errors (VME): False Susceptible (device says susceptible, reference says resistant).
- Major Errors (ME): False Resistant (device says resistant, reference says susceptible).
- Minor Errors (mE): Device says intermediate, but reference says susceptible or resistant, or vice versa.
The "study that proves the device meets the acceptance criteria" for an AST disk typically involves:
- Testing a large number of clinical isolates representing the target organisms (e.g., Enterobacterales, Staphylococcus saprophyticus, Enterococcus faecalis).
- Comparing the zone diameters and interpretive results of the HardyDisk AST Gepotidacin 10µg (GEP10) against an FDA-recognized reference method (e.g., broth microdilution or agar dilution) for gepotidacin.
- Analyzing the EA, CA, VME, ME, and mE rates according to FDA guidance for AST devices.
Since this is NOT an AI/ML device, many of the requested fields (e.g., MRMC studies, number of experts for ground truth beyond standard AST expert review) are not applicable.
Addressing Your Specific Questions based on the Provided Document:
Here's how the provided information aligns (or doesn't align) with your specific questions:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Generalized for AST): For AST devices, typical acceptance criteria involve high rates of Essential Agreement and Categorical Agreement (e.g., >90%), and low rates of Major Errors and Very Major Errors (e.g.,
§ 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).