(217 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with UL544 standards | Met |
| Compliance with UL1778 standards | Met |
| Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND (Electrical, Mechanical & Environmental Performance Requirements) | Met |
| Compliance with requirements for Vibration, Shock, Fluid Spill Tests | Met |
| Compliance with requirements for Temperature and Humidity Tests | Met |
| Compliance with requirements for Radiated Energy and Magnetic Field Testing | Met |
| Compliance with IEC 601-1 (for electrical evaluation) | Met |
| No safety hazards identified | None identified |
| No design characteristics violating reviewer guidance | None identified |
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.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).