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Clearo is indicated for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

The Breas Medical Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy. Clearo is indicated for use on adult or pediatric patients who are unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

The Clearo device is not intended to be used in line with a ventilator.

Clearo must be prescribed by a licensed physician and must be used only as directed by a physician or healthcare provider.

Clearo must be used with a single-limb patient circuits fitted an anti-bacterial filter.

Clearo functions by delivering ambient air at a defined positive pressure to the patient's airways (insufflation), followed by a rapid shift to negative pressure (exsufflation). This quick transition—known as "time through zero" – creates a high expiratory flow that stimulates or simulates a natural cough.

Optional oscillatory vibrations may further aid in loosening and mobilizing secretions. The continued rapid transition to negative pressure helps generate sufficient expiratory flow from the central airways, supporting the clearance of respiratory secretions.

Clearo achieves its intended use through a blower, which compresses air, a solenoid-controlled valve to manage air flow and pressure, and microcontroller electronics to control and monitor the operation. Clearo is powered from either a mains source or an internal battery.

Clearo includes the following device modes to accommodate both clinical and patient use:

• Unlocked (Clinical) Mode: Provides full access to all treatment settings and mode configurations, intended for use by healthcare professionals. Clinicians can enable specific modes for patient use and customize treatment protocols.
• Locked (Patient) Mode: Restricts access to pre-selected modes as set by the clinician. Patients cannot modify treatment parameters but may view compliance data and alarm history.

Clearo provides the following Treatment Modes:

• Manual Mode: The user controls the cycling between insufflation and exsufflation via a manual switch. This mode supports "Insufflation Rise" to control pressure ramp-up. Sessions can be recorded and stored for repeated use using the Treat-Repeat feature.
• Basic Auto Mode: Provides repeated, automatic cycling of insufflation, pause, and exsufflation, with configurable recruitment breaths, pause intervals, rise time, and optional patient-triggered breaths. Optional Stepped Insufflation Breaths gradually increases insufflation pressure across breaths for comfort.
• Program Auto Mode: Similar to Basic Auto but with a customizable, repeatable sequence of multiple insufflations followed by one exsufflation. Includes all features of Basic Auto Mode.

This FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence through technical comparisons and compliance with relevant standards rather than a typical clinical study with acceptance criteria and reported device performance metrics in a tabular format. The document emphasizes performance testing which verifies conformance with requirements, but these are primarily engineering-level tests, not direct clinical performance metrics.

Therefore, many of the requested points regarding sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical data are not explicitly detailed in this provided text because the clearance relies on non-clinical performance and substantial equivalence to a predicate device.

However, I can extract and infer information about the acceptance criteria and study proving device meets them based on the provided text, focusing on the engineering and non-clinical aspects:

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

Based on the provided text, the "acceptance criteria" discussed are primarily adherence to specified technical characteristics and performance within defined ranges, as well as compliance with various medical device standards. The "reported device performance" is framed as the device meeting these specifications and showing comparable waveforms to the predicate.

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

• Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing described is primarily non-clinical performance testing (e.g., pressure, flow, timing, oscillation measurements on the device itself, EMC, electrical safety) and waveform comparison against a predicate device.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective study for clinical data, as this filing relies on engineering performance tests and comparative technological characteristics. It's safe to assume the testing was conducted in a laboratory/engineering environment.

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

• Not applicable/Not mentioned, as the "ground truth" for this submission are the engineering specifications, relevant IEC and ISO standards, and the performance of the predicate device (CoughAssist T70). Expert opinion on clinical efficacy/diagnosis is not the basis for this 510(k) clearance documentation.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Adjudication methods are typically associated with clinical studies involving reader-based interpretations (e.g., radiology images). This submission focuses on objective engineering measurements and compliance with standards.

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 conducted or described. This type of study is relevant for AI/radiology devices where human interpretation is assisted by AI. The Clearo device is a therapeutic device (mechanical insufflation-exsufflation device), not an AI diagnostic imaging tool.

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

• Not applicable. This device is a mechanical medical device, not an AI algorithm. While it has software and microcontroller electronics, its "performance" is its mechanical function, regulated by its design parameters and confirmed through physical measurements and standard compliance.

7. The type of ground truth used:

• The "ground truth" for this submission is primarily:
  • Engineering Specifications and Design Requirements: The device's internal design parameters for pressure, flow, timing, oscillation, etc.
  • International Standards: Conformance to standards like IEC 60601 series, ISO 18562 series, etc., which define safety and performance benchmarks.
  • Predicate Device Performance: The established, legally marketed performance of the Respironics CoughAssist T70 provides the benchmark for "comparable waveforms" and technological characteristics.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the typical sense for algorithm development.

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

• Not applicable, as there is no "training set" as understood in the context of AI/machine learning.

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Clear On Mobile software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Clear on Mobel is not approved for mammography and is meant to be used by qualified medical personnel only. Clear On Mobile is complying with DICOM standards to assure optimum communications between network systems.

ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.

It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.

The provided text is a 510(k) summary for the ClearON Mobile software. It describes the device, its functions, and a comparison to a predicate device. However, it does not contain information about an acceptance criteria table, reported device performance metrics, sample sizes (for test or training sets), data provenance, number or qualifications of experts establishing ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or the specific type of ground truth used.

The document only states that "The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria." but does not elaborate on what those criteria were or what the performance results specifically were.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study that proves the device meets them based on the input provided.

The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing features and stating that the pre and post image processing algorithms are identical. It does not present a performance study with detailed metrics against defined acceptance criteria.

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