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This FDA document is a 510(k) clearance letter for an antimicrobial susceptibility test disc. It does not contain the kind of detailed information typically found in a study report for AI/ML-based medical devices regarding acceptance criteria, performance tables, sample sizes, ground truth establishment, or expert adjudication.
Therefore, I cannot extract the requested information from the provided text. The document confirms that the HardyDisk AST Imipenem/relebactam 10/25ug (IMR 10/25) device, a physical test disc, has been found substantially equivalent to a predicate device. It does not describe a study involving an algorithm or AI.
§ 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).