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

MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen.

MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40kg and 120kg.

MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen:

• Suction a.
  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.

• Supplementary Oxygen b.
  The MOVES® SLCTM 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® device (K093261), 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 Thornhill Research Inc. MOVES® SLC™ medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and study designs (like sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies) that would be present in a submission establishing de novo safety and effectiveness for a novel device or AI algorithm.

The document mainly describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices and compliance with relevant standards.

Here's a breakdown of the information available in the document regarding acceptance criteria and performance, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The "Summary of Performance Testing" section states:

"The results of performance testing demonstrate that the characteristics 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."

And the "Determination of Substantial Equivalence" section reiterates:

"Where differences in performance or technology exist, it has been demonstrated that they do not adversely impact safety or effectiveness. In addition, SLC has been tested to comply with relevant recognized consensus safety and performance standards as well as voluntary standards (detailed above)."

The acceptance criteria, implicitly, are that the device's performance characteristics for ventilation, patient monitoring, oxygen delivery, and suction must be substantially equivalent to those of its predicate devices and comply with all referenced standards and regulations.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. The testing mentioned is "performance testing" and likely refers to engineering, bench, and potentially animal testing, rather than human clinical trials with specific patient sample sizes. The provenance of any data (country, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable/provided. The document describes a medical device (ventilator, monitor, concentrator, suction pump), not an AI algorithm requiring expert-established ground truth on a test set (e.g., for image classification or diagnosis).

4. Adjudication Method for the Test Set

This information is not applicable/provided for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically performed for AI-powered diagnostic aids where the impact on human reader performance is being evaluated.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The MOVES® SLC™ is a hardware medical device with integrated software/control. It is not an "algorithm only" device in the sense of a standalone AI diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in this context. The performance testing refers to the overall device's functionality.

7. The Type of Ground Truth Used

Given that this is a hardware device primarily demonstrating substantial equivalence and compliance with standards, the "ground truth" would be established through a combination of:

• Engineering specifications and measurements: Comparing output parameters (e.g., ventilator pressures, flow rates, oxygen concentration, monitoring accuracy) against known physical standards or the specifications of predicate devices.
• Performance against predicate device specifications: Ensuring that the MOVES® SLC™ meets or exceeds the demonstrated performance of its predicate devices for the various functions.
• Compliance with recognized consensus standards: Meeting the benchmarks set by standards like IEC 60601 series, EN-794-3, ISO 8359, and ASTM E1112-00.

There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" in the context of this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable/provided. The MOVES® SLC™ is not described as a device that uses machine learning or an AI algorithm that requires a "training set" of data. Its control system and functionalities are based on established engineering principles and algorithms, not data-driven machine learning models that are "trained."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided as there is no mention of a training set for an AI algorithm.

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