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The BiWaze Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply.

The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).

The BiWaze Clear System may be used with patient interfaces including face mask, mouthpiece, a trach adapter to endotracheal or tracheostomy tube in acute and home care environments. The BiWaze Clear System may be used in-line with a ventilator in acute care environment only.

The BiWaze Clear System is identical to the BiWaze Clear System cleared under K213564. The present submission extends BiWaze Clear System claims to include use in-line with a ventilator in the acute care environment only.

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 occupving 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 against to open and expand the patient's airways. The nebulizer can be configured to run during PEP therapy to help move the aerosolized saline solution throughout the airways.
• Oscillation (OSC): During OSC, the system oscillates the airways with pulses of . positive pressure to thin secretions and mobilizes 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 the aerosolized saline solution throughout the airways.
• . Nebulize (NEB): During NEB. the system powers only the Aerogen Solo vibrating mesh nebulizer. This therapy gives the patient a break from PEP or OSC while the patient receives their nebulized aerosolized saline.

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

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BiWaze Clear System.

Important Note: The provided document is a 510(k) summary for a medical device and describes its substantial equivalence to a predicate device, rather than providing a detailed clinical study with specific performance metrics against pre-defined acceptance criteria for a new AI/software diagnostic device. The "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence for a non-continuous ventilator, and the "study" is primarily non-clinical bench testing. Therefore, many of the requested fields are not directly applicable or cannot be extracted from this type of document, particularly those related to AI algorithm performance, human readers, ground truth establishment, and sample sizes for training/test sets in an AI context.

Description of Acceptance Criteria and Supporting Study

The BiWaze Clear System (K231728) is a non-continuous ventilator. The acceptance criteria described in this 510(k) summary are centered around demonstrating substantial equivalence to a predicate device (Hill-Rom Volara™ System, K200988) and a reference device (BiWaze Clear System, K213564). This involves showing that the proposed device has similar indications for use, operating principles, technology, and performance, with a specific focus on extending its claims to include "use in-line with a ventilator in the acute care environment only."

The "study" that proves the device meets these acceptance criteria primarily consists of performance bench testing and adherence to various medical device standards.

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

• Specific extended claim: BiWaze Clear use in-line with ventilator is intended only in the acute care environment. |
  | Technology/Performance (Functionality, Safety, Effectiveness): | - Operating principle (Electro-Mechanical device, Air or Oxygen).
• Therapy Modes (PEP, OSC, NEB, with specified pressure/frequency limits).
• Patient Circuit Configurations (Disposable circuit with handset and in-line nebulizer connection).
• Patient Interface (Mouthpiece, Facemask, Trach Adapter, Ventilator Tee Adaptor).
• SpO2 Connection (Supports connection and displays SpO2 values and heart rate).
• Adherence to relevant medical device standards (e.g., IEC 60601 series, ISO 18562 series, ISO 10993-1, IEC 62304, ISO 14971). | - "Functionally, the performance and therapy mode functions are similar to the predicate device."
• "The proposed modifications are changes to the labelling with supporting data from testing without a change in device technology."
• "The core capabilities of the modified BiWaze Clear System remained unaltered compared to the predicate device."
• "The device modifications discussed do not alter the BiWaze Clear device's safety or effectiveness and neither do they change its indication for use compared to the predicate device."
• "Validated through non-clinical bench testing and determined to be substantially equivalent to the predicate."
• Biocompatibility: "no change in design and materials in the gas and fluid pathways are identical to the reference device, BiWaze Clear System (K213564)." |

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

This information is not provided in the document because it pertains to performance data typical for diagnostic AI devices, clinical studies, or usability studies involving human participants. The "test set" here refers to the actual physical device undergoing non-clinical bench testing, not a dataset in the AI sense.

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 and is not applicable for this type of device submission, which relies on engineering and performance standards rather than expert-established ground truth for diagnostic accuracy.

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

This information is not provided and is not applicable for this type of device submission. Adjudication methods are typically used in clinical studies or when establishing ground truth for AI algorithms, which is not the focus here.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the BiWaze Clear System is.

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

This question is not applicable. The BiWaze Clear System is a physical medical device (ventilator) that the document clarifies has no change in underlying technology, but an extended use claim supported by bench testing. It does not employ a standalone AI algorithm in the context typically discussed for diagnostic or assistive AI software.

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

The "ground truth" for this submission is based on established engineering and performance standards for non-continuous ventilators, as well as the performance characteristics of the legally marketed predicate device (Volara™ System). The equivalence is demonstrated through non-clinical bench testing according to these standards, not against a clinical "ground truth" like pathology or outcomes data in the usual sense for a diagnostic device.

8. The sample size for the training set

This information is not provided and is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

This information is not provided and is not applicable, as there is no training set for an AI/ML algorithm in this context.

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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.

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