Search Results

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 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, electro-mechanical 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 follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader-follower 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 IF1000 System and PlanPoint Software are modified to enable Remote Software Updates from the Intuitive server via secure network communication.

The provided text does not contain specific acceptance criteria or details of a study setup (like sample sizes, expert qualifications, or ground truth establishment) to prove that the device meets defined acceptance criteria for its clinical performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria.

The key points from the provided text are:

• Device: Ion Endoluminal System (IF 1000)
• Purpose: Assists users in navigating catheters and endoscopic tools in the pulmonary tract for diagnostic and therapeutic procedures, including fiducial marker placement. It does not make a diagnosis.
• Key Modification (subject of this 510(k)): Added support for Remote Software Updates.
• Claim: The subject device is "substantially equivalent" to its predicate device (K232984).

Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing: The document does not list specific clinical performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or navigation success rates) for the device regarding its primary function (navigation in the pulmonary tract).
• Instead, it states: "The performance testing data confirmed that the device performs as intended to its specifications and meets its intended use." This is a general statement, not a reporting of specific performance metrics against quantitative acceptance criteria.
• The "performance data" section primarily discusses verification and validation (V&V) of the software (including cybersecurity) and animal testing for system design validation. It doesn't present clinical performance outcomes.

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

• Missing for clinical performance: The document mentions "simulated animal models" for "in-vivo animal testing" but does not specify the number of animals or cases in this test set.
• Data Provenance: The animal testing implies prospective data collection, but no country of origin is mentioned.

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

• Missing: Since no specific clinical performance study with human subjects (or a detailed animal study) requiring expert interpretation for ground truth is described with quantitative results, this information is not present. The animal study was performed to "assess the system performance" generally, not against a pre-established expert-adjudicated ground truth for a specific diagnostic or therapeutic outcome.

4. Adjudication Method for the Test Set:

• Missing: Not applicable as detailed expert-adjudicated clinical performance testing for the device's primary function is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No: The document does not mention an MRMC study. The device's clearance is based on substantial equivalence, primarily addressing a software update feature (remote software updates), rather than a comparative effectiveness study of its core functionality or human-AI interaction.
• The document implies that "Changes to the subject device do not affect previously identified critical tasks," and usability testing refers back to the predicate device's data. This suggests no new human factors or clinical performance studies related to reader improvement were conducted for this specific 510(k).

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

• Not explicitly stated for the core navigation functionality: The device is an "Endoluminal System" that "assists the user," implying a human-in-the-loop system. The PlanPoint™ Software creates a 3D plan, which is a software function, but its performance metrics (e.g., accuracy of path planning) are not detailed as standalone acceptance criteria. The software V&V confirms it "meets design specifications and user needs," but doesn't break out standalone quantitative performance.

7. The Type of Ground Truth Used:

• Implied for Animal Testing (Design Validation): The animal testing was for "design validation" and to "assess the system performance." It doesn't specify how "ground truth" was established for precise navigation outcomes within the animal models (e.g., post-mortem pathology, direct visualization, etc.). The focus seems to be on whether the system performed "effectively" generally, rather than hitting a specific, pre-quantified ground truth target.

8. The Sample Size for the Training Set:

• Missing: The document refers to "software verification and validation testing" including "unit, subsystem integration, and system level testing" and "regression testing." This refers to software development and testing phases, not typically a separate "training set" in the context of deep learning or AI model development that would require a distinct sample size. While the PlanPoint software creates 3D plans from CT scans, there's no mention of a machine learning component that requires a specific training dataset and its associated ground truth.

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

• Missing: Not applicable since a "training set" for an AI or machine learning model, with its corresponding ground truth establishment, is not described.

Summary of what is present:

• Acceptance Criteria Mention (General): The document generally states that "performance testing data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements."
• Study Types Mentioned:
  • Software Verification and Validation (including unit, subsystem integration, system level, and regression testing).
  • Cybersecurity Testing.
  • Animal Testing (in-vivo, simulated use conditions) for "system design validation."
  • Usability Testing (references prior study for predicate as no new critical tasks identified).
• Rationale for Substantial Equivalence: The primary rationale for this 510(k) is that the subject device has the "same intended use, indications for use, operating principles, and similar technological characteristics" as the predicate device, with the key modification being a remote software update feature that "does not raise different questions of safety and effectiveness." The testing performed (software V&V, cybersecurity, and animal testing) was to confirm this, not to prove specific clinical performance metrics against quantitative acceptance criteria for navigation efficacy or diagnostic accuracy.

Ask a specific question about this device