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This emergency power source accessory (UPS) is intended for use as a short-term emergency power source for ventilators, for hospital use only.

M1145 (UPS1-1.25K-1G-MP)Uninterruptible Power Supply The (UPS)regenerates new clean, ultra precise AC power to ensure reliable and accurate system operations. It allows for operation during generator checks, extended continued brownouts or complete blackouts.

The provided text describes a 510(k) premarket notification for an Uninterruptible Power Supply (UPS) intended for use with ventilators. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a medical imaging or diagnostic AI device.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth establishment, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this document, as it pertains to a hardware device's safety and effectiveness.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of precise, quantifiable acceptance criteria with corresponding performance metrics in the way one would expect for an AI or diagnostic device. Instead, it relies on meeting established safety and electrical standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The device is a UPS unit, and testing involved physical product testing according to standards, not data analysis from a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth as typically understood for diagnostic or AI devices is not relevant here. The "ground truth" for this device's performance is adherence to engineering and safety standards, which would be evaluated by qualified testing laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. There was no test set requiring expert adjudication for a medical diagnosis or AI output. The testing results were either "met" or "did not meet" the predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. No MRMC comparative effectiveness study was conducted as this is a hardware device, not an AI or diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This is a standalone UPS device; there is no algorithm or human-in-the-loop performance evaluation in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is compliance with established engineering, electrical, and safety standards (e.g., UL544, UL1778, IEC 601-1, FDA Reviewer Guidance) as determined by contract testing laboratories.

8. The sample size for the training set

This information is not applicable. There is no training set in the context of AI development for this hardware device.

9. How the ground truth for the training set was established

This information is not applicable. There is no training set for this hardware device.

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