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510(k) Data Aggregation
(27 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 Enterobacteriaceae, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Use of HardyDisk AST Eravacycline 2015 (ERV20) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria among the Enterobacteriaceae to Eravacycline.
HardyDisk AST Eravacycline at concentration 20μg can be used to determine the zone diameter (mm) of Eravacycline against the following bacteria among the Enterobacteriaceae.
Eravacycline has been shown to be active both clinically and in vitro against the following organisms: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro against most of the following bacteria, but their clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes.
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This document is a 510(k) clearance letter for the HardyDisk AST Eravacycline 20ug (ERV20) device, which is an 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 specific acceptance criteria, study details, or performance data that would allow me to populate the requested table and answer the study-related questions. The document mentions "Performance Studies Microbiologist" and "reviewed your Section 510(k) premarket notification," implying that studies were conducted and reviewed by the FDA, but the details of those studies are not present in this regulatory letter itself.
Therefore, I cannot provide a complete answer to your request based solely on the provided text. To answer your questions, I would need access to the actual 510(k) summary or the full submission which would contain the performance data and study design.
If the information were available, here's how I would structure the answer:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | (e.g., ≥90% for categorical agreement with reference method) | (e.g., XX% for Enterobacteriaceae) |
| Categorical Agreement (CA) | (e.g., ≥90% for categorical agreement with reference method) | (e.g., YY% for Enterobacteriaceae) |
| Minor Discrepancies | (e.g., ≤Z% for minor errors) | (e.g., A% for minor errors) |
| Major Discrepancies | (e.g., ≤B% for major errors) | (e.g., C% for major errors) |
| Very Major Discrepancies | (e.g., ≤D% for very major errors) | (e.g., E% for very major errors) |
2. Sample Size and Data Provenance
- Test Set Sample Size: [Number of isolates tested, broken down by organism if applicable]
- Data Provenance: [e.g., Multi-center clinical trial in the United States and Europe, retrospective collection from various clinical labs, prospective study]
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: [Number, e.g., 2]
- Qualifications of Experts: [e.g., Clinical microbiologists with >10 years of experience in antimicrobial susceptibility testing, board-certified pathologists.]
4. Adjudication Method
- Adjudication Method: [e.g., Not applicable as ground truth was established by a single reference method (e.g., broth microdilution), or if there were discrepancies, a third expert reviewed, 2+1, 3+1, etc.]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. (Based on the nature of this device, a diagnostic test for bacterial susceptibility, MRMC studies are not typically performed. These are more common for imaging devices where human interpretation is a key component.)
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone Performance Study
- Standalone Study Done? Yes. (The performance of the HardyDisk AST Eravacycline 20ug is inherently a standalone performance evaluation of the disc's ability to produce accurate zone diameters compared to a reference method.)
7. Type of Ground Truth Used
- Ground Truth Type: Reference broth microdilution method (e.g., CLSI standard M07 or equivalent), which is the gold standard for determining minimum inhibitory concentrations (MICs).
8. Sample Size for Training Set
- Training Set Sample Size: [Not applicable for this type of device, as it is a physical disc and not an AI/ML algorithm that requires a training set. If it were a software algorithm, this would be a crucial detail.]
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
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