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The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.

MODES OF OPERATION
The EMV+ offers a range of modes using both pressure and volume targeting that can be selected to optimally manage the patient.

Assist/Control (AC): patient receives either controlled or assisted breaths. When the patient triggers an assisted breath they receive a breath based on either the volume or pressure target.

Synchronized Intermittent Mandatory Ventilation (SIMV): patient receives controlled breaths based on the set breathing rate. Spontaneous breaths can be either unsupported or supported using Pressure Support. (The software implementation allows for devices to be configured with and without the SIMV mode feature.)

Continuous Positive Airway Pressure (CPAP): patient receives constant positive airway pressure while breathing spontaneously. Spontaneous breaths can be either demand flow or supported using Pressure Support.

ADDITIONAL ADJUNCTS OF OPERATION
In addition to Modes of Operation, the EMV+ also provides various adjuncts that can be used to manage the patient. Two adjuncts are Pressure Support (PS) and Noninvasive Positive Pressure (NPPV). The table below shows which adjuncts can be used with which modes. It is possible to use more than one adjunct, if the mode permits.

Mode Breath Target Pressure Support (PS) Noninvasive Positive Pressure Ventilation (NPPV) AC V & P No No SIMV V & P Yes No CPAP N/A Yes Yes

Pressure Support (PS): can be used to assist spontaneous breaths in both SIMV and CPAP modes.

Noninvasive Positive Pressure (NPPV): provides flow during the expiratory phase to maintain the baseline pressure (CPAP) in spontaneously breathing patients with a leaking airway or facemask. The amount of leak compensation depends on the leak flow rate during the expiratory period and ranges from 0 to 15 liters/min and is automatically adjusted by the ventilator in order to maintain the CPAP target.

The document provided is a 510(k) summary for a medical device, the Uni-Vent® 731 Series Model EMV+® Portable Critical Care Ventilator. It describes modifications to an already legally marketed device (predicate device K091238), specifically adding new operating modes (SIMV and CPAP with Pressure Support and Leak Compensation).

However, the provided summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML device studies (i.e., performance metrics like sensitivity, specificity, AUC, or the methodology for their calculation).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of technological characteristics: Highlighting the new features and confirming no changes to fundamental scientific technology, materials, biocompatibility, power input, or intended use.
• Compliance with recognized standards: Stating that the device meets the same performance criteria as the predicate, which are specified by a list of national and international standards for ventilators, medical electrical equipment, pulse oximetry, and environmental factors.
• Quality system adherence: Stating that the device design and development process followed ISO 13485 and ISO 14971.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not retrievable from this specific document, as it's a 510(k) submission for a non-AI medical device update.

Here's an attempt to answer the questions based only on the provided document, acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not applicable/Not provided. This 510(k) submission relies on compliance with recognized standards and substantial equivalence to a predicate device, not a distinct clinical "test set" in the context of an AI/ML algorithm evaluation.
• Data provenance: Not applicable/Not provided for performance testing. The document refers to standards compliance and design/development processes.

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)

• Not applicable/Not provided. Ground truth establishment for a test set like in AI/ML performance evaluation is not detailed for this type of medical device submission. The "ground truth" here is adherence to engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

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

• Not applicable. This is not an AI-enabled device. This document does not describe an MRMC study.

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

• Not applicable. This is not an AI-enabled device. The "performance" refers to the device's mechanical and electronic function according to specifications and standards, not an algorithm's diagnostic or predictive output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For a traditional medical device like a ventilator, the "ground truth" for its performance is typically established through direct measurement against established engineering specifications, safety standards, and physiological models/simulators, rather than expert consensus on diagnostic images or pathology. The document indicates compliance with a suite of standards which define these performance criteria.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided. This is not an AI/ML device that requires a training set.

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