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The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.

The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction.

The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.

The provided text describes a medical device, the VOCSN Unified Respiratory System, and its various components, along with comparisons to predicate devices and adherence to performance standards. However, it does not describe a study involving an AI algorithm's performance or human reader improvements. Therefore, I cannot provide details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies, as these elements are not present in the document.

Instead, the document focuses on the VOCSN Unified Respiratory System's regulatory submission (510(k)) to the FDA, demonstrating its substantial equivalence to previously cleared medical devices. This involves non-clinical performance testing against user and product requirements and compliance with international standards.

I will structure the answer based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):

The acceptance criteria are generally framed as compliance with specific international and FDA guidance standards, as well as meeting internal User Requirements and Product Requirements Specifications. The "reported device performance" is essentially the statement that the device is compliant with these standards and requirements, and that verification/validation testing was successfully completed. Specific quantitative performance targets are not always explicitly stated in the summary but are implied by compliance with the referenced standards.

Ventilation Component:

Oxygen Concentrator Component:

Cough Assist Component:

Suction Component:

Heated Wire Patient Circuit Accessory:

Bacteria Filter Accessory:

Regarding AI-specific questions:

The provided document describes a physical medical device (VOCSN Unified Respiratory System), not an AI algorithm. Therefore, the following information is not present in the text:

2. Sample size used for the test set and the data provenance: Not applicable as no AI test set is described. The device performance was validated and verified through simulated use conditions and testing against various standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device validation and verification typically involve engineering and clinical experts during the design and testing phases, but not specifically for establishing "ground truth" in the context of an AI model's performance.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for AI-assisted human reading tasks, which is not the subject of this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" here is compliance with engineering specifications and regulatory standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).

The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.

The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

The Newport HT70 Ventilator provides ventilatory support for neonate, infant, pediatric and adult patients. It can be used in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician. The HT70 ventilator design provides maximum mobility and safety for short or long distance transport of critically ill patients and also for patients who are going about their normal activities of daily life.

The HT70 may be operated from AC or DC external power sources or from the integrated battery system. Any time the ventilator is connected to external power, the integrated battery system is charged, including while the ventilator is in use. The HT70 ventilator has A/CMV, SIMV and SPONT ventilatory modes (Pressure or Volume).

The controls of the HT70 ventilator are easily found on the front touch screen and panel. The touch screen can be set up in Hospital, Transport or Basic functional Domains to provide the user with full or limited access. The HT70 has a Trends screen for displaying data graphically. User Help screens present information for all controls and features.

This document describes a 510(k) submission for the Newport HT70™ Ventilator, seeking authorization for enhancements including an on-airway flow sensor for exhaled volume monitoring and flow trigger, and SpO2 monitoring. This is a traditional 510(k) submission to authorize a modification to an already existing device and therefore does not include a comparative effectiveness study. No standalone studies were included with the submission packet. Hence, based on the provided document, I am unable to provide a response for the following sections:

1. A table of acceptance criteria and the reported device performance: This document does not describe the specific performance characteristics being evaluated, nor does it list any acceptance criteria. It states that the device has undergone "extensive verification, validation and design safety testing," which confirm it meets "design, performance, and safety requirements," but no specific metrics are provided.
2. Adjudication method
3. 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
4. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
5. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
6. The sample size for the training set
7. How the ground truth for the training set was established

Here's what can be extracted from the provided text:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified. The document states "extensive verification, validation and design safety testing" were performed, but no specific sample size for a test set is mentioned for the enhancements.
• Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether the studies were retrospective or prospective.

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

• Not applicable as the document does not mention any ground truth establishment by experts for the device's performance related to the enhancements. The submission focuses on device modifications and testing to ensure it meets design and safety requirements, rather than a diagnostic performance evaluation against an expert-established ground truth.

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The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11lb), who require the following types of ventilation support, as prescribed by an attending physician.

• Positive pressure ventilation
• Assist / control, SIMV, or CPAP modes of ventilation
  The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.

A VELA with the CO2 monitoring option is intended to monitor the effectiveness of ventilation. It may be used on adult and pediatric patients. It is suitable for use in a hospital critical care environment, and is a restricted medical device intend for use by qualified trained personnel under the direction of a physician.

The VELA Series Ventilator is a modified Tbird Ventilator and like its predecessor, is an easy to use, self-contained, servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for pediatric through adult patients. Its revolutionary user interface module provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery turbine with servo controlled active inhalation and exhalation improves performance over previous generations.

The VELA Series Ventilator may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It is easy to clean and its design does not allow liquids to pool on the casing, reducing the likelihood of fluid leakage into the body of the ventilator.

The VELA Series Ventilator base model comes with comprehensive features for the critical care environment. Optional features can be added at time of purchase or at a later date.

The provided text describes the VELA Ventilator and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific quantitative performance targets against a defined acceptance criterion.

Here's what can and cannot be extracted from the provided text according to your request:

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

• Not Available: The document does not specify any quantitative acceptance criteria or reported device performance metrics in the way you've outlined (e.g., sensitivity, specificity, accuracy against a gold standard). The "Summary of Testing and Validation" states, "In Summary Performance testing verified that the VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to predicate medical devices currently legally marketed in the United States." This is a general statement and does not provide specific criteria or results.

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

• Not Available: The document does not describe a clinical test set, its sample size, or data provenance. The validation seems to be based on performance testing to ensure it meets requirements for substantial equivalence, not a clinical study with a "test set" in the context of AI/diagnostic device performance.

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 Available: Since there is no described test set or study involving "ground truth" establishment by experts (as would be for an AI or diagnostic device), this information is not provided.

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

• Not Applicable/Not Available: As above, no such adjudication method is mentioned.

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/Not Available: The VELA Ventilator is a mechanical ventilator, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or included.

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

• Not Applicable/Not Available: The device is a ventilator, a mechanical medical device, not an algorithm.

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

• Not Applicable/Not Available: Ground truth as typically defined for diagnostic or AI devices is not relevant to the information provided about this mechanical ventilator. The "ground truth" in this context would likely be the accurate delivery of ventilation parameters as measured by engineering tests.

8. The sample size for the training set

• Not Applicable/Not Available: As a mechanical device, there is no "training set" in the machine learning sense.

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

• Not Applicable/Not Available: As above, there is no training set mentioned.

In summary: The provided document is a 510(k) summary for a ventilator, focusing on demonstrating substantial equivalence to existing predicate devices. It describes the device, its intended use, and indicates that performance testing was conducted to verify it meets its requirements. However, it does not detail specific acceptance criteria, study methodologies, or performance metrics in the format typically required for diagnostic or AI-based devices.

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