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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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MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit.

MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases.

The MADM™ system is a portable vaporizer capable of delivering anesthetic to the inspiratory limb of a breathing circuit. Unlike other in-line vaporizers, MADMTM can be inserted into a circle system where some exhaled anesthetic is rebreathed. The MADM™ system measures the anesthetic concentration of incoming gas and reduces the anesthetic output to ensure the anesthetic concentration of gas delivered to the patient is as set on the dial.

MADM™ includes an internal battery backup capable of powering the device for 20 minutes, and an optional external battery base with hot swappable batteries capable of powering the system for over two hours. Anesthetic is stored in custom single agent anesthetic canisters.

This document is a 510(k) premarket notification summary for the Thornhill Research Inc. MADM™ device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving acceptance criteria for its performance metrics.

However, based on the provided text, we can extract the following information regarding performance testing and acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device meets the acceptance criteria of international standards for anesthetic delivery accuracy and gas sensing accuracy. However, specific numerical acceptance criteria (e.g., ±X% accuracy) and the reported performance values are not explicitly provided in this summary. The summary states:

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

The document mentions "Performance testing" and "Safety and Performance Testing" but does not specify the sample size for any test sets used. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature of the data). This level of detail is typically found in the full test reports, which are not included in this summary.

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

The summary does not mention the use of experts to establish ground truth for a test set. The performance testing described appears to be engineering and laboratory-based testing against established standards and internal system requirements, rather than clinical studies requiring expert consensus on subjective outcomes.

4. Adjudication Method for the Test Set:

Since there is no mention of experts or a "test set" in the context of expert review, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this device is an anesthesia gas machine and monitor, not an interpretive diagnostic imaging or AI-driven system that would typically involve human readers. The document focuses on the device's standalone performance compared to standards and predicates.

6. Standalone Performance:

Yes, a standalone performance evaluation was done. The "Summary of Performance Testing" section details various tests conducted on the MADM™ device by itself to validate its system requirements and compliance with standards. This includes:

• Performance testing across the intended environmental operating range.
• Battery Longevity testing.
• Anesthetic delivery accuracy.
• Disturbance analysis.
• Anesthetic compatibility evaluation.
• Biocompatibility Evaluation.

The conclusion states that the performance characteristics demonstrate substantial equivalence and meet acceptance criteria of international standards.

7. Type of Ground Truth Used:

The ground truth used for the performance testing appears to be based on:

• International standards and regulations: Compliance to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-13, ISO 80601-2-55.
• System requirements: The device's internal design specifications and functional requirements.
• Physical measurements/instrumentation: For accuracy (anesthetic delivery, gas sensing) and longevity (battery).
• Chemical/material compatibility testing: For anesthetic compatibility.

8. Sample Size for the Training Set:

The concept of a "training set" is typically applicable to machine learning or AI models that learn from data. The MADM™ device, as described, is a physical medical device (vaporizer, monitor) with embedded controls, not an AI system. Therefore, the notion of a "training set" is not relevant in this context, and no information about one is provided.

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

As there is no "training set" in the context of this device, this question is not applicable. The device's design and operation are based on engineering principles and validated through testing against established physical and safety standards.

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