Search Results

The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen supply.

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting.

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting.

The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The oscillating lung expansion therapy of the BiWaze Clear System is intended to reduce airway obstructions caused by secretions occupying the lower airways, prevent respiratory tract infections, re-expand the collapsed areas of the lung, thereby enhancing gas exchanges and reducing inflammatory response.

BiWaze Clear provides three respiratory therapies: PEP. OSC. and NEB.

• Positive Expiratory Pressure (PEP): During PEP, the system delivers a programmed positive pressure which the patient exhales aqainst to open and expand the patient's airways. The nebulizer can be configured to run during PEP therapy to help move saline throughout the airways.
• Oscillation (OSC): During OSC, the system oscillates the airways with pulses of . positive pressure to thin secretions and mobilize them from the lower airways to the upper airways so they can be coughed or suctioned out. The nebulizer can be configured to run during OSC therapy to help move saline throughout the airways.
• Nebulize (NEB): During NEB, the system powers only the Aerogen Solo vibrating mesh . nebulizer. This therapy qives the patient a break from PEP or OSC while the patient receives nebulized saline.

The BiWaze Clear System can be used in coniunction with the various patient interfaces such as facemask, mouthpiece or a trach adapter which connects to a patient's endotracheal or tracheostomy tube. It is intended to deliver therapy to pediatric and adult patients in acute. post-acute, and home care settings.

The BiWaze Clear System provides a closed-circuit the Dual Lumen Breathing Circuit that prevents aerosolized exhale air from escaping the handset or breathing tube before being filtered by a coaxial bacterial/viral filter.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for each criterion against a specific threshold. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance data and comparisons. The "acceptance criteria" are implied by the performance characteristics of the predicate device and the new device's ability to match or be comparable to them.

However, based on the text, we can infer the key areas of performance that were evaluated and for which the new device (BiWaze Clear System) was found to be "substantially equivalent" to the predicate (Volara™ System).

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

• Sample Size: The document does not specify a numerical "sample size" in terms of number of patient cases or units for the test set. The performance data is based on "bench testing" and "non-clinical testing." This implies laboratory-based tests on device units rather than patient data.
• Data Provenance: Not applicable in the context of patient data, as no clinical studies with human subjects were conducted or submitted. The testing was entirely non-clinical bench testing.

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

• This question is not applicable as there was no ground truth established by experts in the context of human physiological or pathological conditions. The "ground truth" for the device's performance was established by engineering and performance specifications and comparison to the predicate device's measured performance in a bench setting.

4. Adjudication Method for the Test Set

• This question is not applicable as there was no expert adjudication process due to the absence of clinical studies and human-based ground truth establishment. Performance was directly measured against specifications and predicate device behavior.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This question is not applicable. The BiWaze Clear System is a mechanical therapeutic device (Noncontinuous Ventilator for secretion mobilization and lung expansion), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance effect size is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. The device is not an algorithm; it is a standalone mechanical medical device that performs therapies. Its performance is inherent to the device itself, not dependent on or enhanced by a human-in-the-loop interaction in the way AI algorithms are evaluated.

7. The Type of Ground Truth Used

• The ground truth used for demonstrating substantial equivalence was primarily engineering specifications, direct comparative measurements against a legally marketed predicate device (Volara™ System), and compliance with recognized industry standards (e.g., IEC 60601-1, ISO 10993-1). No expert consensus, pathology, or outcomes data from human patients were used.

8. The Sample Size for the Training Set

• This question is not applicable. The BiWaze Clear System is a physical device, not a machine learning model. Therefore, it does not have a "training set" in the context of AI.

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

• This question is not applicable for the same reason as point 8; there is no training set. Design and development would have been guided by engineering principles and existing medical knowledge of respiratory therapies.

Ask a specific question about this device

The Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 - 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.

The Aerobika® OPEP device and VersaPAP™ device can be used independently or combined. When combined for ease of use. The combined device creates oscillations during the exhalation phase (OPEP) to aid in secretion clearance and during the inhalation phase (PAP) helps to maintain positive airway pressure for the treatment and prevention of atelectasis.

The provided text is a 510(k) summary for the "Combined VersaPAP™ device and Aerobika® OPEP" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria in the format requested.

Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the detailed format you requested (table, sample size, expert information, MRMC study, standalone performance, ground truth). The document is a regulatory submission for a medical device that performs a physical function (providing positive airway pressure and positive expiratory pressure), not an AI/software as a medical device (SaMD) that typically undergoes rigorous performance studies with the criteria you outlined.

However, I can extract the information relevant to what I can infer as "acceptance criteria" and "study" within the context of this device application:

The "acceptance criteria" for this type of device are primarily demonstrating substantial equivalence to existing legally marketed predicate devices, meaning it is as safe and effective as the predicates. The "study" that proves this involves bench testing and comparison of features and performance characteristics to the predicates.

Here's how I can reframe the information based on the provided text:

Inferred Acceptance Criteria and Study to Prove Device Meets Them:

For this device, "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance (like sensitivity/specificity for AI), but rather as proof of substantial equivalence to legally marketed predicate devices. The "study" involves bench testing and a detailed comparison of technical and performance characteristics to demonstrate this equivalence.

1. Table of Acceptance Criteria (as inferred) and Reported Device Performance:

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

• Sample Size: Not applicable in the context of an FDA 510(k) for this type of physical device; there isn't a "test set" of patient data for diagnostic performance. The "testing" refers to bench testing of the device's physical performance. The document states, "We performed comparative testing at adult and child breathing setting to the predicates and reference." However, no specific number of test runs or 'samples' is given.
• Data Provenance: Not applicable in the way it would be for an AI model (e.g., retrospective/prospective patient data, country of origin). The data provenance is from bench testing conducted by the manufacturer, Trudell Medical International (located in London, ON, Canada).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This is not a study requiring expert consensus for ground truth as it's a physical device, not an AI diagnostic tool.

4. Adjudication Method for the Test Set:

• Not applicable. There's no "test set" that requires adjudication by human readers/experts.

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

• No. This type of study is typically done for AI-assisted diagnostic tools to assess human reader improvement. This is a physical medical device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is a physical device, not an algorithm. Its "standalone" performance would refer to its physical output which is measured via bench testing as described in bullet 1.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by engineering and physiological measurement standards (e.g., measuring pressure, flow rate, and frequency) during bench testing, and comparing these measurements to the established performance of predicate devices and expected physiological ranges.

8. Sample Size for the Training Set:

• Not applicable. This is a manufactured physical device, not a machine learning model.

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

• Not applicable. There is no concept of a "training set" or "ground truth establishment" in the AI sense for this device. Its design and manufacturing (analogous to "training") are based on engineering principles and regulatory requirements for medical devices.

Ask a specific question about this device