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Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe 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. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors 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 ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

The ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).

The provided document is a 510(k) premarket notification letter and summary for the ZOLL 731 Series Ventilator. It details the device, its intended use, and the comparisons made to a predicate device to establish substantial equivalence.

However, the request asks for information about acceptance criteria and a study that proves a device meets those criteria, specifically in the context of an AI/algorithm-driven medical device. The document provided does not describe an AI/algorithm-driven device. Instead, it is for a ventilator (a mechanical device with updated software), and the "study" referred to is primarily non-clinical evidence (software verification and validation testing, safety testing per international standards, electrical safety, EMC, and usability testing with no changes to the UI). There is no mention of an algorithm or AI that generates outputs requiring ground truth, expert adjudication, or MRMC studies for evaluation.

Therefore, I cannot fulfill the request with the provided input because the input document does not contain the necessary information about acceptance criteria and studies for an AI/algorithm-driven device.

The document explicitly states:

• "Clinical evidence was not necessary to show substantial equivalence."
• The primary change is a "software revision 5.25, which updates the ventilator alarm logic." This is a rule-based or programmatic change, not an AI/ML model.
• The comparison is based on "Alarm System, Functions and Features, Indications for Use, Intended Use, Labeling, Pulse Oximeter Specifications, Ventilator Specifications." These are typical for traditional medical device updates, not AI.

If the request refers to general device acceptance criteria and testing (not specific to AI/algorithms), then the relevant parts of the document are the "Substantial Equivalence - Non-Clinical Evidence" section, which details the various tests and standards met:

• Software Verification and Validation Testing: This is the primary "study" proving the device meets its software-related acceptance criteria. The document states this testing "ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all its functional requirements and performance specifications."
• Safety Testing per International Standards: Compliance with a long list of international standards (IEC 60601-x, ISO 15223-1, EN 1789, etc.) serves as the acceptance criteria for safety and effectiveness in various aspects. The "Table 1: 731 Series Ventilator Compliance Standards" lists these.
• Usability Testing: The document states "No usability validation is included in this plan. The user interface remains unchanged." This implies that the acceptance criterion for usability was "no change from predicate" and thus no new testing was needed.
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested to meet applicable standards listed in Table 1.

However, the request is very specific about AI-related evaluation elements (MRMC, standalone algorithm, ground truth methods, training set, etc.), which are entirely absent from the provided document.

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Ventilation

Each model of the ZOLL 731 Series of Ventilators is in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe 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. When marked with an " label, ZOLL Ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL 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

Pulse Oximetry (SpO2)

The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse SpO2 oximeter and accessories are indicated for use on adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

The ZOLL 731 Series Ventilators family (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc. and reviewed and cleared under K111473) consists of AEV, EMV+ and Eagle II models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (> 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV)/ Positive Pressure Ventilation (PPV).

As part of the current submission we are proposing to revise the device software to accomplish the following:

• Introduce Bilevel Mode Functionality
• Expanded Leak Compensation Functionality
• Introduce Start Menu Functionality
• . Expanded Parameter Ranges
• . Introduce Plateau Pressure (Pplat) Functionality
• . Introduce Automatic Tubing Compensation Functionality
• Change Oxygen Supply Pressure Alarm Logic
• Introduce Inverse I:E Ratio Functionality ●

No hardware changes were made to the 731 Series Ventilators for the proposed software change.

The provided text describes a 510(k) premarket notification for the ZOLL 731 Series Ventilators, focusing on software changes that introduce new functionalities. The document primarily focuses on non-clinical evidence to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a specific table of "acceptance criteria" with numerical targets and corresponding "reported device performance" values in the traditional sense of a clinical or analytical performance study. Instead, the acceptance criteria are implicitly tied to the successful completion of various engineering and software validation tests, and compliance with recognized standards.

The document states:
"Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all of its functional requirements and performance specifications."
and
"The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 794-3, IEC 60601-1-8 and ISO 80601-2-61."

Therefore, the reported device performance is that these tests were passed and compliance was achieved, demonstrating that the device meets its design, performance, and safety specifications and is substantially equivalent to predicate devices.

Example Interpretation of Acceptance Criteria and Performance (as implied by the document):

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 clinical data for performance evaluation. All testing mentioned is non-clinical (software verification/validation, safety testing, usability testing). Therefore, details like sample size for a test set (e.g., number of patients), country of origin, or whether it was retrospective/prospective are not applicable or provided.

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):

This information is not provided. Since no clinical "test set" requiring ground truth establishment by experts is described, this detail is not relevant to the presented evidence.

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

This information is not provided because no clinical "test set" or expert adjudication process is described in the document.

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 study was conducted or reported. The device is a ventilator with software updates, not an AI-assisted diagnostic tool for human readers.

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

The device is a medical device (ventilator) with software as an integral component, not a standalone algorithm in the typical sense applied to AI/ML devices. The performance evaluation focuses on the integrated system (ventilator with new software). The software's performance was validated as part of the overall device performance through non-clinical testing.

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

Not applicable for the non-clinical testing described. For software verification and validation, the "ground truth" would be the pre-defined functional and performance specifications, and for safety, it would be compliance with published standards.

8. The sample size for the training set:

Not applicable. The document describes software updates to a medical device, not a machine learning or AI algorithm that requires a "training set" of data.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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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.

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."

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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).

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