Search Results

The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp.

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

I am sorry, but the provided text from the FDA 510(k) K103456 document does not contain the detailed information necessary to answer the questions about acceptance criteria and study results for a device that uses AI or machine learning.

The document describes the Sensititre AIM™, an instrument for inoculating Sensititre MIC or BP Susceptibility plates, which falls under the category of Antimicrobial Susceptibility Test Powder. The 510(k) is primarily for the addition of this "AIM" instrument to an existing system.

The content focuses on regulatory approval, substantial equivalence, and general controls, rather than performance studies with acceptance criteria typically associated with advanced algorithmic or AI-driven medical devices. Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance validation.
• Sample size for the training set.
• How ground truth for the training set was established.

This document predates the widespread regulatory submissions for AI/ML devices and therefore does not contain the type of data requested.

Ask a specific question about this device