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The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The provided text is a 510(k) clearance letter for the Thermo Scientific Sensititre ARIS HiQ System. It describes the device's indications for use but does not contain any information about the acceptance criteria, study design, or performance metrics that would be required to answer the questions about how the device meets acceptance criteria.

Specifically, the document does not provide any data or details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for ground truth, or details about training and test sets.
3. Whether MRMC or standalone studies were conducted, or details about ground truth establishment.

Therefore,Based on the provided document, I cannot answer the questions about the acceptance criteria and the study that proves the device meets those criteria.

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The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The provided FDA clearance letter for the Thermo Scientific Sensititre ARIS HiQ System (K191914) does not contain the detailed information required to answer your questions regarding acceptance criteria and performance study specifics.

The document is a standard FDA 510(k) clearance letter, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device. It briefly describes the device's intended use (automated plate management, incubator, OptiRead module for reading Sensititre susceptibility plates, generating MIC and interpreting breakpoint results for non-fastidious microorganisms) and regulatory classification.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for test or training sets.
3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.

To obtain this information, one would typically need to refer to:

• The full 510(k) submission document itself, if it were publicly available with performance study details.
• Performance study reports provided by the manufacturer to the FDA.
• Clinical trial summaries or publications if the device involved such studies.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The information is simply not present in this FDA clearance letter.

Ask a specific question about this device