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The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

The Ion™ Endoluminal System (hereinafter referred to as the Ion System) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The Ion System Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, Swivel Connector, and Vision Probe Bag facilitate use of the Ion System Instruments.

The provided FDA 510(k) summary for the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) focuses on demonstrating substantial equivalence for an increase in the device's use life from 5 to 8 uses. This is not a typical submission for a novel AI/ML-based medical device where performance data relates to diagnostic accuracy, sensitivity, or specificity of an AI algorithm.

Therefore, the information required for explaining an AI device's acceptance criteria and proven performance (specifically sections regarding AI/ML performance, sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not present in this document. This submission primarily relies on bench testing, cleaning validation, and biocompatibility studies to justify the increased reprocessing cycles.

However, I can extract the acceptance criteria and the reports of meeting those criteria based on the information provided, framed within the context of a device durability/reuse validation:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of units tested. The documentation refers to "testing" in general.
• Data Provenance: Not applicable in the context of clinical data for AI performance. The tests are laboratory/bench-based.

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

• Not Applicable: This submission does not involve human expert interpretation of data to establish ground truth for a diagnostic AI. The "ground truth" here is the adherence to engineering and safety standards validated through laboratory testing.

4. Adjudication Method for the Test Set

• Not Applicable: There is no adjudication process described as this is not a study assessing human perception or diagnostic accuracy. Performance is determined by passing predefined engineering and biological safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No: An MRMC study was not performed as this is not a submission for an AI-assisted diagnostic or therapeutic device that impacts human reader performance.

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

• No (Not Applicable): This is not a submission for an AI algorithm. The "System Software" mentioned is likely operating software for the robotic system, not a diagnostic AI.

7. The Type of Ground Truth Used

• Engineering and Safety Standards: The "ground truth" for this device's performance validation is its adherence to established engineering specifications (functional performance over repeated uses) and recognized safety standards (cleaning efficacy, biocompatibility).

8. The Sample Size for the Training Set

• Not Applicable: This document describes validation testing for an increased use life, not the development or training of an AI model.

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

• Not Applicable: No AI training set is discussed or implied.

Summary of why the requested AI-specific information is not present:

The FDA 510(k) submission K240135 for the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) is specifically for an increase in the device's reusability/use life (from 5 to 8 uses) of an existing cleared device. It primarily relies on non-clinical performance data (bench testing, cleaning validation, biocompatibility) to demonstrate that increasing the use life does not introduce new safety or effectiveness concerns. This is fundamentally different from a submission for a novel AI/ML-based medical device that would require extensive clinical performance data, ground truth establishment, and often comparative studies with human readers.

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