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The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.

The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital transport includes patient transport within the hospital or hospital-type facility.

The Newport e500 Wave Ventilator is a pneumatically powered, microprocessor controlled ventilator cleared through Premarket Notification.

Performance characteristics and clinical features support infant/pediatric (>20 mL) through adult patients.

Front panel controls allow trained operators to select ventilation controls under volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes.

A comprehensive alarm system is built-in to alert the user to violations of preset safety limits.

The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).

Here's a breakdown of the acceptance criteria and study information for the Newport e500 Wave Ventilator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:
The document states that "All test results met pre-defined acceptance criteria," but it does not explicitly list the specific values or thresholds for these criteria (e.g., what constitutes "meeting" a standard, or the exact ranges for performance metrics). It provides a high-level statement of compliance.

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

• The document does not specify the sample size used for the test set.
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective). It describes "Comprehensive verification and validation testing," which implies laboratory or simulated testing rather than clinical data from human subjects.

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

• This information is not provided in the document. The testing described is verification and validation, likely against engineering specifications and industry standards, not against "ground truth" established by clinical experts in the sense of diagnostic accuracy.

4. Adjudication Method for the Test Set

• This information is not provided. Given the nature of the testing described (hardware, software, electrical safety, etc.), an adjudication method by human experts for a "test set" in the context of diagnostic performance is not applicable. The device's performance was evaluated against technical specifications and safety standards.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done or mentioned. This type of study is relevant for AI/diagnostic devices where human readers interpret medical images or data. The Newport e500 Wave Ventilator is a continuous ventilator, not a diagnostic imaging device.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

• The document describes "Comprehensive verification and validation testing" including hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. This implies standalone testing of the device's components and overall system performance without human intervention in the loop, to ensure it meets its pre-defined specifications and safety standards. However, it's not "algorithm only" in the sense of a standalone AI model's performance being evaluated. It's the performance of the integrated device system.

7. Type of Ground Truth Used

• The "ground truth" for the testing appears to be pre-defined acceptance criteria based on:
  • Engineering specifications and design requirements.
  • Compliance with international standards (ISO9703-1, ISO9703-2, EN475 for alarms).
  • Functional safety requirements.
  • Electrical safety requirements.
  • EMC (Electromagnetic Compatibility) standards.

8. Sample Size for the Training Set

• This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models that learn from data. While the ventilator is microprocessor-controlled, the document does not suggest it uses a machine learning algorithm that would require a distinct "training set" for its core functionality as described.

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

• As a "training set" is not indicated for this device's type of functionality in the provided text, this information is not applicable or provided.

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The e500 Ventilator is intended to provide continuous (ET tube) or noncontinuous (mask) ventilatory support and monitoring for infant, peditric and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.

The intended environments include hospital, hospitaltype and intra- hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities suc h as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.

The Newport e500 Wave Ventilator is a self-contained, electrically powered microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (=20mL) through adult patients.

Front panel controls allow trained operators to select between a number of operational modes, pressure support and volume or pressure control. A comprehensive alarm system is built-in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides an average of 1.5 hours of power.

The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).

The provided text describes a 510(k) submission for the Newport e500 Wave Ventilator, asserting its substantial equivalence to predicate devices. However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in a format that lends itself to direct extraction for the requested table and analytical points.

Instead, the document focuses on regulatory compliance, outlining the device's characteristics, intended use, and comparison to predicate devices, along with the results of non-clinical tests demonstrating adherence to various standards. It concludes that the device has "functionally proven to be safe" and "meets its stated performance specifications."

Therefore, I cannot directly populate the requested table or provide detailed responses to points 1-9 as a specific "study" with set acceptance criteria, sample sizes, and ground truth establishment is not presented in the provided text.

The closest information available is:

• Acceptance Criteria (implied): Conformance to various domestic and international standards (IEC601-1, CISPR 11, EN60601-1-2, EN 794-1, ISO9703-1&2, ASTM F 1100-90, MIL-STD461D, MIL-STD810E) and the "FDA Reviewer Guidance for Ventilators" and "Reviewer Guidance for Premarket Computer Controlled Medical Devices Undergoing 510(k) Review." The device must also be "safe" and "effective" as the predicate devices.
• Reported Device Performance: "The Newport e500 Wave Ventilator meets all applicable device specification requirements for performance testing" and "functionally proven to be safe. The device meets its stated performance specifications."

Without a dedicated study section detailing performance against specific, quantifiable acceptance criteria, the other points (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document. The document primarily focuses on regulatory approval through substantial equivalence and compliance with established standards, rather than presenting a performance study against novel acceptance criteria.

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