Search Results

The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.

The New Aera Tidal Assist Ventilation (TAV) system comprises a small, lightweight, wearable, battery-powered ventilator, TAV-C100, and a nasal pillow interface, TAV-NP10. The system is intended to connect to an air or oxygen source and supports three modes of delivery:

• Tidal Assist mode, a breath-activated ventilation assist mode in which the delivered gas from the source entrains additional room air at the nasal pillows interface, delivering it under positive pressure during the patient's inhalation to assist breathing;
• Conserve mode, a breath-activated delivery mode used to conserve oxygen consumption when using a cylinder with regulator; and
• Constant mode, presenting a continuous 1 – 5 LPM flow of oxygen to the patient.
  For the Tidal Assist mode, the user may select one of five flow delivery settings, corresponding to a delivered minute volume of approximately 1 - 5 LPM.
  For the Conserve mode, the user may select one of five pulse delivery settings, corresponding to an equivalent gas flow rate of approximately 1 - 5 LPM.
  For the Constant mode, the user may select one of five flow delivery settings, corresponding to a delivered gas flow rate of approximately 1 - 5 LPM.
  The TAV system is battery operated, running from a single AA alkaline battery. Under typical usage, battery life is ~ 14 days; a low battery alert activates when battery life is less than 2 days under typical usage.
  The system has a simple user interface, comprising:
• a mode selection button;
• buttons to increase or decrease the delivered flow rate;
• a button to turn the device on and off, and to temporarily silence any alarms;
• LED indicators for the current delivery mode, flow setting, and low battery and alarm conditions; and
• an audible buzzer used to alert the user to an alarm condition.
  The device has two pneumatic ports:
• an inlet port, used to connect the regulated gas source to the device, and
• an outlet port, used to connect the device to the patient interface.
  Lastly, the device has a bypass valve, used to deliver a constant 2 LPM gas flow rate to the patient in the event of a system failure.

The provided text describes the New Aera Tidal Assist™ Ventilator (TAV™) System and its substantial equivalence to a predicate device, the Breathe Technologies – NIOV Ventilator (BT-V2S).

Here's the breakdown of the acceptance criteria and the study information based on the provided document:

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

The document does not explicitly present a table of "acceptance criteria" for performance metrics with specific numerical targets. Instead, it compares the proposed device's features and performance to a predicate device (BT-V2S) and a reference device (Chad Evolution Model OM-900) to demonstrate substantial equivalence. The "acceptance criteria" are implied by the similarity to the predicate device and meeting general performance specifications and standards.

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

The document lists "Non-clinical Performance Testing" which includes:

• Bench testing: Comparison of Total Delivered Volume, comparison of Delivered Volume with oxygen vs. air, comparison of waveforms, Battery life and run-time, Alarms, Trigger Sensitivity, Back-up rate, Delivered volume in different modes, Shelf-life, Oxygen and Fire hazard testing, Accelerated Aging, Cleaning pre- and post- performance.
• Biocompatibility testing
• Electrical, EMC, EMI testing
• Usability study

The document does not specify sample sizes (e.g., number of devices, number of test runs) for these non-clinical tests.
It also does not provide any information on data provenance such as country of origin or whether the data was retrospective or prospective, as these are non-clinical bench and usability studies, not clinical trials with patient data.

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 is not applicable as the document describes non-clinical performance and usability testing. "Ground truth" in the context of expert review for medical image analysis or similar diagnostic tasks is not relevant here. The "ground truth" for performance would be established by validated test methods and reference standards.

For the usability study, two user groups were involved:

• Healthcare Professionals (HCPs)
• Lay Users (patients and caregivers)
  The number of participants in each group is not specified, nor are their specific qualifications beyond being an HCP, patient, or caregiver.

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

This is not applicable to the described non-clinical performance and usability testing. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation of data by multiple experts.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a ventilator, 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

This is implicitly addressed by the extensive non-clinical bench testing. The performance specifications like bolus size, breath rate, trigger sensitivity, alarms, and delivered volume in different modes were tested directly on the device itself, without human intervention for performance interpretation. The device's technological functions, such as its trigger sensitivity algorithm with signal artifact correction, were tested for consistent performance.

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

For the non-clinical tests, the "ground truth" would be established by:

• Reference standards and validated measurement equipment: For physical performance metrics like delivered volume, flow rate, pressure, and battery life.
• Compliance with recognized industry standards: Such as those listed (e.g., IEC 60601-1, ISO 10993-1) for electrical safety, EMC, and biocompatibility.
• Pre-defined acceptance criteria for functional performance: For features like alarm activation, backup modes, and shelf-life, which are evaluated against specified parameters.
• Observation against pre-defined critical tasks: For the usability study, where observed performance of users on critical tasks indicated successful usability.

8. The sample size for the training set

This information is not provided. The document describes a 510(k) submission focused on demonstrating substantial equivalence through non-clinical testing, not the development or training of an AI algorithm. If internal algorithms are present (e.g., for trigger sensitivity), details about their training would typically not be included in this type of submission summary.

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

This information is not provided and is not applicable in the context of this 510(k) submission summary for a ventilator device.

Ask a specific question about this device