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The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

a. Suction
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

b. Supplementary Oxygen
The MOVES® SLC™ is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

c. Patient Monitoring
The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), a portable multifunction patient support and monitoring system with the following capabilities:

• Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
• Delivery of oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator.
• Patient monitoring functions including the following patient parameters: Pulse Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
• Suction/aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure.

The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

The provided text is a 510(k) summary for the MOVES® SLC™ medical device, which is an emergency ventilator with additional functions. This document describes the device, its indications for use, and its comparison to predicate devices to demonstrate substantial equivalence. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

Specifically, the document:

• Does not provide a clear table of acceptance criteria and reported device performance. It offers a comparison table of features and characteristics between the MOVES® SLC™ and predicate devices, including some performance specifications like frequency range, tidal volume, and SPO2 accuracy, but these are comparative, not acceptance criteria.
• Does not mention anything about sample sizes used for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This is because the device is a piece of hardware (ventilator, monitoring, suction, oxygen concentrator) and not an AI/software device that would typically involve such studies for regulatory clearance.
• Does not discuss a training set or how ground truth for a training set was established. This is irrelevant for a hardware medical device of this type.
• States that "Testing was conducted in accordance with all referenced standards and regulations, and to validate all system requirements" and a "Summary of Performance Testing" section mentions that "The results of performance testing demonstrate that the characteristics the MOVES® SLC™ are substantially equivalent to the identified predicates in terms of ventilator characteristics, patient monitoring performance, ability to delivery supplemental oxygen, and provide airway suction." However, it does not explicitly detail the specific performance test results against a defined set of acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on demonstrating substantial equivalence to existing predicate devices based on features, characteristics, and compliance with general medical device standards, rather than proving performance against specific acceptance criteria through clinical studies involving human readers or AI algorithms.

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