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The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIMTM 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 non fastidious gram negative organisms.

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.

This appears to be a 510(k) clearance letter for the Sensititre AIM™ device, which is an instrument used to inoculate Sensititre MIC or BP Susceptibility plates for antimicrobial susceptibility testing. The provided document itself does not contain the detailed study information, acceptance criteria, or performance data that would be typically found in a clinical study report or a summary of safety and effectiveness.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring extensive new clinical trial data that would be presented in the format you're requesting. The detailed performance data would have been submitted by the manufacturer as part of their 510(k) submission, but it's not included in this public-facing clearance letter.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample sizes used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method for the test set: This information is not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
• If a standalone (algorithm only) performance study was done: This information is not present. The Sensititre AIM™ is an instrument for inoculation, not an algorithm in the sense of AI/ML.
• The type of ground truth used: This information is not present.
• The sample size for the training set: This information is not present.
• How the ground truth for the training set was established: This information is not present.

What the document does tell us:

• Device Name: Sensititre® AIM™
• Intended Use: The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. It 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 non-fastidious gram-negative organisms.
• Device Function: It 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, affixes a disposable dosehead to the glass tube containing the final inoculum density, and places it into the AIM's pump assembly for dispensing into microtitre plates.
• Regulatory Pathway: 510(k) substantial equivalence. This means the device was found to be as safe and effective as a legally marketed predicate device. The performance data justifying this equivalence would have been submitted to the FDA in the original 510(k) application.
• Product Code: LIE, JWY, LRG
• Regulation Number/Name: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder (Note: This regulation name seems to refer to the reagents, not directly to the instrument itself, highlighting that the AIM is part of a larger system.)

To obtain the detailed acceptance criteria and study data for the Sensititre AIM™, one would typically need to review the original 510(k) submission summary (often called the 510(k) Summary or 510(k) Statement) which is usually publicly accessible on the FDA website for cleared devices, or directly from the manufacturer.

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