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Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae.

Oxoid Amoxicillin/Clavulanic Acid Susceptibility Test Disc

The provided text is a 510(k) summary from the FDA for a medical device: "Amoxicillin/Clavulanic Acid Antimicrobial Susceptibility Test Disc." This document approves the device and states its intended use, but it does not contain information about acceptance criteria or the specific study that proves the device meets those criteria.

The 510(k) notification process establishes substantial equivalence to a predicate device, which implies that the device is as safe and effective as a legally marketed device. However, the details of the performance study (acceptance criteria, sample sizes, ground truth establishment, expert involvement, etc.) are typically found in the full 510(k) submission, not in the FDA's clearance letter or the brief 510(k) summary.

Therefore, I cannot provide the requested information based on the given input text. The text does not describe an acceptance criteria table, device performance reports, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training set ground truth.

The document only provides:

• Device Name: Oxoid Amoxicillin/Clavulanic Acid Susceptibility Test Disc
• Indication for Use: Semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms, including Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae.

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