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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, Model IF1000, 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 IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.

The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.

The System Cart contains the Instrument Arm, electronics for the slave portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the master/slave relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.

The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.

The Catheter Instrument has a tool channel compatible with the Peripheral Vision Probe. Flexision™ Biopsy Needles, and third-party tools. The Vision Probe provides direct visualization of the patient's airways during navigation. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, and Swivel Connector facilitate use of the IF1000 Instruments.

The provided text describes the 510(k) summary for the Ion™ Endoluminal System and Flexision™ Biopsy Needle. It details performance data but does not include a specific table of acceptance criteria with reported device performance or a standalone study with quantitative metrics for accuracy, sensitivity, or specificity.

However, I can extract information related to the device's validation and the types of studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "validation and verification testing demonstrate that the subject devices are equivalent to the predicate devices in terms of safety and effectiveness." and that "the design output meets the design input requirements" and "the System meets design specifications and user needs."

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

The document mentions "animal and cadaver testing" and a "summative validation study" for human factors.

• Animal and Cadaver Testing:

  • Sample Size: Not explicitly stated. The text notes "Cadavers" (plural) and "Live animal models" (plural).
  • Data Provenance: Prospective (simulated use conditions). No specific country of origin is mentioned, but typically, these studies are conducted within the submitting company's or collaborating research facilities.

• Human Factors Evaluation (Summative Validation Study):

  • Sample Size: Not explicitly stated. It involved "intended user groups."
  • Data Provenance: Prospective (simulated bronchoscopy suite).

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the animal/cadaver testing or human factors evaluation. It implies that these studies were overseen by qualified personnel as part of the overall design verification and validation process. For the human factors study, "intended user groups" were involved, suggesting participation from physicians or clinical staff who would typically perform such procedures.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the performance studies mentioned. The evaluation of "safety or performance" and "accuracy" in animal/cadaver models, and the assessment of "high-risk use scenarios and essential tasks" in the human factors study, likely relied on expert observation and assessment without a multi-reader adjudication process detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is described in this document. The focus is on demonstrating the device's safety, effectiveness, and substantial equivalence to predicate devices, rather than a direct comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an "endoluminal system" that "assists the user in navigating a catheter and endoscopic tools." The description of the System Cart's "master/slave relationship" with the Controller and the "3D guided navigation view" indicates it is a human-in-the-loop system. While "Software Verification and Validation" was performed, a standalone algorithm-only performance study (without human-in-the-loop) for a clinical outcome is not explicitly discussed. The PlanPoint™ Software "creates a 3D plan... and navigation pathways," which is an algorithmic function, and its verification would have been part of the software testing. However, its performance as an aid to the human user is part of the integrated system.

7. The Type of Ground Truth Used

• Animal and Cadaver Testing: The ground truth for these studies would have been established through direct observation during the simulated procedures, potentially involving anatomical dissection, histological analysis of biopsied tissue (if sample quality was assessed), and clinical assessment by veterinarians or physicians during animal studies for safety and performance.
• Human Factors Evaluation: Ground truth here relates to task completion, error rates, and user interface effectiveness, observed and recorded during simulated use scenarios.

8. The Sample Size for the Training Set

The document does not provide details on sample sizes for training sets. It focuses on the validation and verification of the final product. The PlanPoint™ Software uses patient CT scans to create 3D plans, which implies an underlying model that would have been developed using a training set, but this information is not included in this submission summary.

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

Information on how the ground truth for any potential training data used for the PlanPoint™ Software (e.g., for segmentation or pathway generation models) is not provided in this document.

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