Search Results

The IMPACT® Model 323 Aspirator is a self-contained suction apparatus designed for use in removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials from wounds, either during surgery or at the patient's bedside. It is suitable for use in pre-hospital, hospital, mass casualty and transport environments. The Model 323 is only for use by or on the order of a physician.

The IMPACT® Model 323 Aspirator is a completely self-contained suction source. It is lightweight, compact, easy to use and is easy to clean. It features a vacuum gauge, integral mounting hardware, power switch, rechargeable batteries, adjustable vacuum regulator, 800 cc collection container, integral carry handle, and convenient stowage of the container holders. The device is housed within an injection molded plastic case.

The provided text describes a 510(k) submission for the IMPACT® Model 323 Aspirator, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with AI components or human-in-the-loop performance measurement. Therefore, much of the requested information regarding acceptance criteria derived from AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, and MRMC studies, is not applicable to this document.

However, the document does specify performance criteria related to the device's functional integrity and safety.

Here's a breakdown of the information available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission details the premarket notification for a physical medical device, not a software or AI-driven diagnostic/prognostic tool. The "test set" in this context refers to bench testing performed on the device itself, not a dataset of patient information for AI evaluation. The document does not specify the number of units tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth in the context of AI models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is established by its compliance with international standards and FDA guidance through bench testing.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in human expert labeling for AI training/testing, which is not relevant to this device's evaluation.

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. MRMC studies are used to evaluate diagnostic imaging systems, particularly in the context of AI assistance for human readers. This document is for a suction aspirator.

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

• Not Applicable. This is a hardware medical device, not an algorithm.

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

• The "ground truth" or reference for the device's performance is compliance with established international and national technical standards and regulatory guidance documents (e.g., IEC 60601-1, IEC 60601-1-2:2007, EN ISO 10079-1:2009, FDA Guidance for Powered Suction Pump 510(k)s, FDA Guidance on Human Factors and Usability Engineering). This compliance is typically verified through various forms of engineering and functional bench testing.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning product and therefore does not have a "training set."

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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

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.

The Uni-Vent ® Model 731EMV+ is a portable, microprocessor controlled, electrically or pneumatically powered intensive care ventilator designed to use either oxygen (02) from a 55 psig source or ambient air using an internal compressor power to deliver a positive pressure breaths. The unit can be electrically powered from an externating current source, external direct current (DC) source or the internal DC battery. An intuitive point-turn-and click interface allows the operator to set and monitor ventilation in all operating environments. A series of alarms alert the user operator to all conditions that affect the ventilator's operation and/or performance and provide context sensitive help relevant to the alarm condition. Ambient air is filtered using a particulate filter or when the operating environment requires either a bacterial/viral or chemical/biologic (NATO No: 4240-01-361-1319) filter. The unit is contained in an impact resistant polycarbonate case which protects of the controls from damage and inadvertent manipulation.

The Uni-Vent ® Model 731EMV+ internal pulse oximeter connects to the patient using noninvasive sensors to monitor oxygen saturation and pulse rate. Pulse oximeter specific alarms and instructions are presented to the operator through the user interface. Isolated DC power is provided to the pulse oximeter.

The provided text is a 510(k) summary for a continuous ventilator, the Uni-Vent® Model 731EMV+. It focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices.

This document does not contain information regarding:

• Acceptance criteria for device performance.
• Results of a study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance for testing.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for a training set was established.

Therefore, I cannot provide the requested table and information based directly on the given text.

The document is a regulatory submission for premarket notification (510(k)) and primarily addresses:

• Device Description: A portable, microprocessor-controlled intensive care ventilator.
• Intended Use: For infant through adult patients (≥5 kg) with acute or chronic respiratory failure or during resuscitation, in various environments (hospitals, transport, austere environments), to be used by skilled care providers, EMS personnel, and first responders under direction.
• Substantial Equivalence: It claims substantial equivalence to two predicate devices:
  1. Impact, Model 731EMV (K071526)
  2. Pulmonetic Systems, Inc. LTV 1200 Ventilator (K060647)

To find the information you're looking for, one would typically need to consult a detailed design validation report, clinical study report, or a comprehensive test report, which are separate from this 510(k) summary document. These documents would outline the specific performance tests conducted, the acceptance criteria for those tests, "and the results showing that criteria were met."

Ask a specific question about this device

The Model 731EMV (EMV) is indicated for use in the management of adolescent and adult patients weighing ≥30 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.

The Uni-Vent @ Model 731EMV is a portable, microprocessor controlled, electrically or pneumatically powered intensive care ventilator designed to use either oxygen (02) from a 55 psig source or ambient air using an internal compressor power to deliver a positive pressure breaths. The unit can be electrically powered from an external alternating current source, external direct current (DC) source or the internal DC battery. An intuitive point-turn-and click interface allows the operator to set and monitor ventilation in all operating environments. A series of alarms alert the user operator to all conditions that affect the ventilator's operation and/or performance and provide context sensitive help relevant to the alarm condition. Ambient air is filtered using a particulate filter or when the operating environment requires either a bacterial/viral or chemical/biologic (NATO No: 4240-01-361-1319) filter. The unit is contained in an impact resistant polycarbonate case which protects of the controls from damage and inadvertent manipulation.

The Uni-Vent @ Model 731EMV internal pulse oximeter connects to the patient using noninvasive sensors to monitor oxygen saturation and pulse rate. Pulse oximeter specific alarms and instructions are presented to the operator through the user interface. Isolated DC power is provided to the pulse oximeter.

This 510(k) summary describes a medical device, specifically a continuous ventilator, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found for AI/ML-driven devices.

The document focuses on:

• Device Description: The Uni-Vent® Model 731EMV is a portable, microprocessor-controlled intensive care ventilator. It uses oxygen or ambient air, can be electrically powered, and has an intuitive interface. It also includes a noninvasive pulse oximeter.
• Intended Use: For adolescent and adult patients (≥30 kg) with acute or chronic respiratory failure, or during resuscitation. It's for use in hospitals, outside hospitals, during transport, and in austere environments. It can operate with a third-party filter in chemical/biological toxin environments but not explosive ones. Intended users are skilled care providers, EMS personnel, and first responders under direction.
• Substantial Equivalence: The device is deemed substantially equivalent to several predicate devices, including other Impact Uni-Vent models, a Masimo pulse oximeter, Versamed SmartVent, and Vela Bird Products.
• Regulatory Information: Classification as Class II, Product Codes CBK and DQA.

Therefore, the requested information regarding acceptance criteria and performance study results cannot be extracted from the provided text. This type of detail is more common in submissions for AI/ML devices where specific performance metrics are critical for regulatory clearance. For devices like this ventilator, substantial equivalence to existing devices often forms the primary basis for clearance, along with adherence to relevant performance standards (which are not detailed here).

Ask a specific question about this device

Ask a specific question about this device

The Model 730 AEV ™ is intended to provide continuous ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. It is appropriate for use with adults and children- in clinical, field hospital, fransport, aeromedical and pre-hospital (BLS through ATLS) environments.

Model 730 AEVTM is a portable, electronically controlled ventilator. It is controlled by an internal microprocessor (CPU), which continuously monitors and displays airway pressure, control settings, high-pressure alarm setpoint, gas volumes, and power signals. Two CPR and two Quick-Start Modes are available- one each is for use with unintubated patients (Mask) and one each is for use with intubated patients (Tube). This product operates from internal rechargeable batteries, external AC and 11-15 volts DC.

The provided text for the Uni-Vent® AEVTM Model 730 device describes its performance standards and guidelines but does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a study.

Instead, the document states:

• Performance Standards: The Model 730 AEVTM complies with various voluntary standards like ASTM F920-99, ASTM F1100-97, ISO9703-1, ISO 9703-2, CGA V-5:2000, ISO 5356-1, EN1441, MIL-STD-1472F, ANSI/AAMI HE74:2001, MIL- STD-810F, and EN60601-1. It explicitly states, "No applicable mandatory performance standards or special controls exist for this device."
• Substantial Equivalence: The primary basis for its clearance is a "comparative examination and analysis of similarities and differences to its predicate devices" concluding that "no new safety and/or effectiveness issues have been raised."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as the information is not present in the provided text. The device received 510(k) clearance based on its substantial equivalence to predicate devices and compliance with voluntary consensus standards, rather than a standalone performance study with defined acceptance criteria and human evaluation metrics.

Ask a specific question about this device

Impact Universal Single-Limb Ventilator Circuit is intended for use in conjunction with ventilators having a single-limb circuit interface. The ventilator circuits are used as a means by which to transfer breathing gases from a ventilator to a patient (inhalation) and from a patient to atmosphere (exhalation). The device is intended for use with adults and medium to large pediatric patients.

The Impact, Universal Single-Limb, Portable Ventilator Circuit is comprised of disposable connectors, tubing and exhalation valve.

The provided text describes the Impact, Universal Single-Limb, Portable Ventilator Circuit and its substantial equivalence to a predicate device. However, it does not contain information about "acceptance criteria" and "device performance" in the format of a table with numerical values, nor does it detail a study that explicitly demonstrates the device meets specific acceptance criteria in the way typically found for AI/ML-based medical devices.

The document focuses on demonstrating substantial equivalence for a physical medical device (a ventilator circuit). This involves showing that the new device has the same intended use and performance attributes as a legally marketed predicate device. The performance attributes are evaluated through biological qualification safety tests and industry-recognized test methods.

Therefore, many of the requested elements for an AI/ML device study are not applicable or not present in this document. I will extract the information that is available and indicate where the requested information is not provided.

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with numerical performance metrics for the device. Instead, it refers to general compliance with safety and performance standards.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for an AI/ML device. The testing described involves material and functional performance of the device itself, not a dataset for an algorithm. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" for a physical device's performance is typically established through adherence to engineering specifications and performance standards, not expert consensus on data.

4. Adjudication method for the test set

Not applicable. There is no "test set" or adjudication process described as would be relevant for an AI/ML device's output.

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 device is a physical ventilator circuit, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and human reader improvement with AI are not relevant.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The "ground truth" equivalent for this device is based on compliance with established international and national standards for medical device materials and functional performance. This includes:

• Biological qualification safety tests (ISO 10993, USP 25, 21 CFR 177.1350)
• Industry-recognized test methods (ASTM F-1100, Table 2)
• Demonstration of performance attributes being the same as the predicate device.

8. The sample size for the training set

Not applicable. This device does not have a "training set" as it is not an AI/ML model.

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

Not applicable.

Ask a specific question about this device