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The MOVES™ 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.

The MOVES™ is intended to deliver high inspired oxygen concentrations via the MOVES™ O2 mask to spontaneously breathing patients who require elevated inspired oxygen.

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

MOVES™ provides the following supplemental functions for patients that it is ventilating or to whom it is delivering elevated inspired oxygen:

a. Suction
The MOVES™ 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 MOVESTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

C. Patient Monitoring
The MOVESTM 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 alams will be available to the care provider from the monitor.

The MOVES™ is 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 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 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 510(k) summary for the MOVES™ device does not contain specific acceptance criteria in quantitative terms (e.g., minimum sensitivity, specificity, or error rates) or detailed results of a study designed to prove the device meets such criteria. Instead, it relies on a comparison to predicate devices and adherence to recognized standards.

Here's an analysis based on the information provided, outlining what is or isn't present regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it claims substantial equivalence to predicate devices and compliance with various IEC, ISO, ASTM, and ANSI/AAMI standards. The "reported device performance" is described qualitatively as meeting "all of its performance requirements" and being "substantially equivalent" to predicate devices.

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

This information is not provided in the document. The summary refers to "performance testing" but does not detail the methodology, sample sizes (e.g., number of test subjects, test scenarios, or data points), or provenance of any data used in such testing.

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

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The validation approach is based on demonstrating equivalence to existing devices and compliance with technical standards.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a study requiring a test set with adjudicated ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The device is not an AI-assisted diagnostic tool that would typically involve human readers.

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

This concept is not applicable in the context presented. The MOVES™ is a medical device for patient support and monitoring, not an algorithm being evaluated for standalone diagnostic or assistive performance. The "performance testing" mentioned refers to the device's functional operation.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/imaging studies (e.g., pathology, expert consensus) is not directly applicable here. For this type of device, the "ground truth" would be the engineering specifications and performance capabilities of the device as measured against recognized standards and the performance of predicate devices. For example, a ventilation parameter's accuracy would be verified against a reference standard or precision instrument, not an expert opinion.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The MOVES™ device is not described as utilizing machine learning or AI that would require a "training set" in the conventional sense. Its "computer-controlled" nature implies programmatic logic rather than learned models.

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

This information is not applicable as there is no mention of a "training set" or a machine learning component requiring one.

In summary: The 510(k) process for the MOVES™ device focused on demonstrating substantial equivalence to already cleared predicate devices and compliance with relevant industry standards. The summary does not provide specific quantitative acceptance criteria or detailed results from a clinical or performance study with defined sample sizes, expert involvement, or ground truth establishment in the way one would expect for an AI/diagnostic software submission. The "performance testing" mentioned is general and aimed at confirming functional operation and safety against established standards and predicate device performance.

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The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

The HI-Ox80 is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 |pm. It is a simple device consisting of a central manifold section where the patient mask, oxygen tubing and an oxygen reservoir bag attach. The triple valving in the manifold directs the oxygen to the patient and acts as an anti-asphyxiation valve removing the need for ventilation holes in the mask itself, thus allowing for delivery of high FiO2's.

Oxygen from the supply is either delivered to the patient via a one-way valve (inhalation valve) or stored temporarily in the oxygen reservoir bag. During exhalation, expired gas is directed to the atmosphere via another one-way valve (exhalation valve). In the event the patient's minute ventilation exceeds the oxygen supply flow rate, a third sequential dilution valve allows ambient air to get drawn into the inspired limb of the manifold eliminating the potential for asphyxiation.

The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1,5 cmH,O, typically ~ 1.07 cmH2O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve is specified to be less than 3 cmH2O/U/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.

Here's an analysis of the provided text regarding the Hi-Ox® High FiO2 Mask, focusing on acceptance criteria and the study used to demonstrate compliance.

Hi-Ox® High FiO2 Mask - Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the tests performed. It mentions "experiments conducted using a SensorMedics 229 metabolic measurement system." It does not specify the number of subjects or runs.

The data provenance is not explicitly stated regarding country of origin. The company is SensorMedics Corporation, located in Yorba Linda, CA, USA. This suggests the tests were likely conducted in the USA. The study design appears to be prospective as it describes direct experimentation to measure product performance.

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

There is no mention of experts being used to establish a ground truth with regard to the performance metrics (FiO2, flow resistance). The measurements for these criteria seem to be objective, instrument-based readings. For the "work of breathing," subjective testing was performed, but the number or qualifications of individuals providing this feedback are not specified.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the reported performance seems to be based on direct measurements and objective criteria, not on expert consensus or interpretation requiring adjudication.

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 device is not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This device is a physical medical device (oxygen mask), not an algorithm or software. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

7. The Type of Ground Truth Used

The ground truth for the performance criteria (FiO2, flow resistance) was based on objective, instrument-based measurements. For the "work of breathing," it was based on subjective patient feedback.

8. The Sample Size for the Training Set

This device does not involve machine learning or AI, so there is no training set and therefore no sample size for such a set.

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

As there is no training set, this question is not applicable.

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