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The Pulmo Via Working Channel is intended to be used as an access channel through which a bronchoscope and other endoscopic tools may be introduced to treat targeted tissue of the airways. The Pulmo Via Working Chamel can also provide means for bronchoalveolar lavage. The PulmoVia Working Channel is indicated for adult patients.

The PulmoVia Working Channel is a single-use disposable, terminally-sterilized device for transtracheal access to bronchi of the lungs, and consists of a hollow tube with an angled flexible tip to assist in anatomical navigation. A radiopaque marker is located 4 mm from the distal tip to aid in localization under fluoroscopy/CT. Printed markings are positioned at 370 mm from the distal tip, and every 50 mm proximally from that point. The distal tip of the device has a pliable leading edge. The device also contains a disposable Tuohy-Borst adaptor to allow use of third-party devices such as ultrathin bronchoscopes. The full assembly will be packaged in a polyethylene and Tyvek pouch, sterilized via ethylene oxide (EO).

The provided text is a 510(k) Summary for the Sanovas, Inc. PulmoVia Working Channel. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or effectiveness through clinical trials in the same way a PMA would require. Therefore, the information provided reflects this context.

Here's an analysis 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 submission does not explicitly list "acceptance criteria" in the traditional sense of performance metrics for a diagnostic or therapeutic device (e.g., sensitivity, specificity, accuracy for an AI device). Instead, it establishes substantial equivalence through a comparison of technological characteristics and non-clinical performance testing against predicate devices. The "acceptance criteria" here are implicitly meeting the performance and safety as demonstrated by the predicate devices and general medical device standards.

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

The document does not describe a clinical "test set" in the context of an AI device. The evaluations were non-clinical (bench testing, biocompatibility).

• Non-clinical testing (mechanical tests): The document does not specify a quantitative sample size (N-number of devices tested) for the mechanical tests. It only states "side by side testing" was performed.
• Biocompatibility testing: Standardized ISO documents are cited, implying compliance with typical sample size requirements for such tests, but no specific numbers are given.
• Usability assessments: Conducted in a "simulated use environment," but no sample size for users or cases is provided.
• Data Provenance: All testing appears to be internal (laboratory/bench testing) for the device manufacturer or contracted labs working for the manufacturer. There is no mention of country of origin for data or whether it was retrospective or prospective in the clinical sense, as no clinical data was used.

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

This section is Not Applicable as no clinical test set requiring expert ground truth was performed for this 510(k) submission. The evaluation was non-clinical.

4. Adjudication Method for the Test Set

This section is Not Applicable as no clinical test set requiring expert adjudication was performed.

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

This section is Not Applicable. The device is a physical medical instrument (a working channel for bronchoscopes), not an AI-powered diagnostic or therapeutic tool for which an MRMC study would be relevant. No AI component is described.

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

This section is Not Applicable. The device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" was established by:

• Industry Standards: Compliance with ISO 10993 series for biocompatibility.
• Engineering Specifications: The device's design requirements and specifications for mechanical properties (e.g., pull strength, kink resistance, leak proofing).
• Predicate Device Characteristics: Comparison of physical and technological characteristics against established predicate devices.
• User Feedback: (Implicitly) "Usability assessments were conducted in a simulated use environment to optimize the safety of the device design and validate the usability of the device."

8. The Sample Size for the Training Set

This section is Not Applicable as the device is not an AI algorithm requiring a training set.

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

This section is Not Applicable as the device is not an AI algorithm requiring a training set.

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