Search Results

The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.

The V8800 Critical Care Ventilator may be used by trained professional health care providers under the supervision of a physician.

The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation.

The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.

The V8800 Crtical Care Ventilator is intended for use in hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.

The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a medical device (Oricare V8800 Critical Care Ventilator) and an "Indications for Use Statement."

While it confirms the device's regulatory clearance and intended use, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment details as requested in your prompt.

Therefore, I cannot extract the information needed to fill out your table and elaborate on the study details.

Ask a specific question about this device

The devices in the Model 731 Ventilator Series are 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. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). When marked with an "MRI conditional" label, they are suitable for use in an MRI environment with appropriate precautions, as defined in the Operation Manual. The Model 731 Ventilators are 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. The EMV+® and Eagle II'" (with and without MRI label) have a full range of ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV). The AEV® (with and without MRI label) has a more limited range of ventilation modes for less sophisticated operators (AC, CPAP with PS and PPV).

The Model 731 Ventilators are a small, extremely durable, full-featured portable mechanical ventilators designed to operate in hospitals or austere and under-resourced environments. The unit is a volume and pressure targeted, time or flow cycled ventilator designed to use either oxygen (O2) from a 55 psig source or fresh air using its internal compressor to deliver a positive pressure breath. The unit contains a pulse oximeter which is intended for continuous noninvasive monitoring of arterial hemoglobin (SpO2) and pulse rate (measured by the SpO2 sensor). The unit contains various controls and indicators that are placed to facilitate ease of use and visibility in all operating environments. A liquid crystal display (LCD) provides continuous display of control settings, operating conditions, power, and alarm status information. The unit uses a comprehensive suite of alarms to alert the operator and guide their actions to resolve the alarm condition and assure patient safety. At the onset of an alarm, the screen displays the alarm name and then a series of context-sensitive help messages. These messages serve to guide the operator by presenting suggestions as to the cause and resolution of a particular alarm. When multiple alarms occur they are prioritized and displayed based on the risk to the patient. The unit 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 demand flow or supported using Pressure Support. (This mode is not available in the AEV® unit.) 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. The unit contains a built-in back up ventilator mode that is designed to provide a limited degree of operation should certain types of failures occur to the primary operating system. The unit can be used in environments where chemical and/or biological toxins are present. To do this safely, all gas delivered to the patient comes from either a pressurized medical-grade O₂ source and/or filtered ambient air entrained through the FRESH GAS/EMERGENCY AIR INTAKE. Operators can chose between a bacterial/viral filter and a chemical/biological filter based on the direction of the Medical Control Officer. To prevent the patient from breathing contaminated ambient air in the event of a ventilator failure, the unit contains an internal anti-asphyxia valve that allows the patient to inspire gas through the external filter. The unit continuously monitors environmental conditions (temperature and ambient pressure) and when extreme environments are detected the operator is alerted by a low priority alarm which defines the operating condition and prompts the actions of the operator. The unit uses a rechargeable lithium-ion battery which offers a wide temperature operating range, does not exhibit "memory" characteristics (reduced capacity) or vent hydrogen gas. The unit can use O₂ from low flow sources, O₂ flow meters and O₂ concentrators, to provide supplemental O₂ to patients. To do this, O₂ is entrained through the Fresh Gas/Emergency Air Intake when the unit's internal compressor cycles to deliver a breath. The testing in MRI environment was done with a 3.0 T Siemens Trio scanner, which has a magnetic field of 0.2 T (500 gauss) at a distance of slightly more than 1 meter (~3.3 feet) from the bore entrance. There was no effect on either the ventilator functionality or the MRI performance at a distance of 2 meters.

The provided text is a 510(k) summary for the Uni-Vent® Model 731 Series Portable Critical Care Ventilators. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared device (K103318), with the main difference being the addition of operation in an MRI environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A 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)

The document does not specify a "test set" in the context of patient data. The evaluation appears to be entirely non-clinical performance testing focused on the device's interaction with an MRI environment and its functional performance. No human subjects were involved. As such, there is no sample size for a test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).

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. Since the performance evaluation was non-clinical testing of device functionality and MRI compatibility, there was no "ground truth" to be established by experts in the context of medical diagnoses or interpretations. The acceptance criteria were met through direct measurements and observations during testing.

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

Not applicable. As noted above, there was no "test set" involving human interpretation or diagnosis that would require an adjudication method.

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

No MRMC comparative effectiveness study was done. This submission is for a medical device (ventilator), not an AI-based diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm or AI system. Its performance was evaluated as a standalone medical device in various operational conditions, including an MRI environment.

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

The "ground truth" for the non-clinical performance evaluation was based on predefined engineering specifications, regulatory standards (e.g., ASTM F1100), and the physical effects measured during MRI compatibility testing. For example, "no effect on ventilator functionality" or "no effect on MRI performance" measured against established baselines determined the passing criteria.

8. The sample size for the training set

Not applicable. This device is a ventilator, not an AI or machine learning system that requires a "training set."

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

Not applicable. As there is no training set for this device, there is no ground truth establishment method for it.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests.

• MRI Compatibility Testing: The primary study mentioned is testing for MRI environment compatibility. This involved placing the ventilator near a 3.0 T Siemens Trio scanner which has a magnetic field of 0.2 T (500 gauss) at approximately 1 meter. The testing demonstrated "no effect on either the ventilator functionality or the MRI performance at a distance of 2 meters." This test was conducted in accordance with the acceptance criteria defined in the FDA Draft Guidance "A Primer on Medical Device Interactions with Magnetic Resonance Imaging systems," covering aspects like location of testing, imaging sequence, effect on medical device, and generation of artifact/noise, all of which "passed."
• Breathing Circuit Performance: The longer breathing circuit required for MRI operation was tested and "passed testing to ASTM F1100 requirements."
• Waveform and Volume Performance: Sections 5.3 and 5.4, related to "Waveform Performance" and "Volume Performance" respectively, also "passed." (Specific details of these tests are not provided in this summary but are indicated as having met their criteria).

In summary, the provided document details a non-clinical evaluation to demonstrate the safe and effective operation of the Uni-Vent® Model 731 Series Portable Critical Care Ventilators, particularly in an MRI environment, by meeting specific pre-defined performance and safety criteria through direct physical testing and measurement against established standards.

Ask a specific question about this device

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.

Ask a specific question about this device