(54 days)
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Fosfomycin Sensi-Discs® are intended for use in determining the susceptibility to Fosfomycin of a wide range of bacteria, including Enterococcus faecalis, Enterococcus faeclum, Escherichia coli, Citrobacter diversus, Citerobacter freundii, Entercbacter aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, and Serratia marcesceus. Zone sizes used tor interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Forest Pharmaceuticals, Inc., and received FDA approval under NDA No. 50-717.
Use of BBL Fosfomycin Sensi-Discs®.for in .vitro .agar diffusion.susceptibility. testing is indicated when there is a need to determine the susceptibility of bacteria to Fosfomycin. Fosfomycin has been shown to be active against most strains of microorganisms listed below, as described in the Forest Pharmaceuticals, Inc., package insert for this antimicrobic.
Active In Vitro and In Clinical Infections Against: Aerobic Gram-Positive Microorganisms Enterococcus faecalis Aerobic Gram-Negative Microorganisms Escherichia coli Active In Vitro Only Against: Aerobic Gram-Positive Microorganisms Enterococcus faeclum Aerobic Gram-Negative Microorganisms Citrobacter diversus Citerobacter freundii Enterobacter aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Serratia marcesceus
Antimicrobial Susceptibility Test Discs
The provided text describes a 510(k) submission for "Fosfomycin, 200 mcg, Sensi-Discs" and provides a "Summary of Safety and Effectiveness." However, it does not include detailed acceptance criteria or a study proving the device meets those criteria in the format requested. The document primarily focuses on the device's labeling, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results with specific metrics.
Therefore, most of the information requested in your prompt cannot be extracted directly from the provided text.
Here's what can be gathered and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The document mentions "Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Forest Pharmaceuticals, Inc., and received FDA approval under NDA No. 50-717." This implies that the acceptance criteria for the interpretation of the device's results are based on established standards for Fosfomycin, but the performance of this specific Sensi-Disc against those criteria is not detailed.
- Reported Device Performance: Not provided in a quantitative form (e.g., accuracy, sensitivity, specificity, reproducibility).
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The ground truth seems to be implicitly linked to the "Forest Pharmaceuticals, Inc., package insert for this antimicrobic" but how this was established in the context of the Sensi-Disc's performance is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 device is an antimicrobial susceptibility test disc (a physical laboratory consumable), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Again, this is not an algorithm or AI device. It's a laboratory consumable. Standalone performance as an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth is implied to be based on the established clinical breakpoints and susceptibility interpretations for Fosfomycin, as determined by the antimicrobic manufacturer (Forest Pharmaceuticals, Inc.) and FDA-approved under NDA No. 50-717. This would typically involve correlation with minimum inhibitory concentration (MIC) testing (a gold standard for antibiotic susceptibility) and clinical outcomes data from the drug's initial approval. However, the specific method for establishing ground truth for this particular Sensi-Disc performance study is not detailed.
8. The sample size for the training set
- Not specified. This device is not an AI/machine learning model, so the concept of a "training set" in that context does not apply.
9. How the ground truth for the training set was established
- As above, not applicable in the context of AI/machine learning training.
In summary, the provided document is a regulatory approval letter and a summary of the device's intended use and relationship to a predicate device. It lacks the detailed performance study data, acceptance criteria, and methodology that would typically be found in a clinical or validation study report.
§ 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).