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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 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 in 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 Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.

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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. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater.

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 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 in 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.

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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 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.

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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 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 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 Ion Endoluminal System enables optional Network and Virtual Reference features, streamlined mid-procedure restart, and enhances the control algorithm to provide an additional safety margin.

The provided text is a 510(k) summary for the Ion Endoluminal System (Model IF1000). While it describes software verification and validation, cybersecurity testing, and animal testing to demonstrate substantial equivalence to a predicate device, it does not contain specific acceptance criteria or detailed study results for an AI/algorithm's performance.

The device is primarily an electromechanical system with software for navigation and planning. The "PlanPoint™ Software" uses patient CT scans to create 3D plans, which is a software function, but the document does not treat it as a standalone AI algorithm that makes diagnoses or performs automated tasks requiring specific performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Therefore, I cannot provide the requested information in the format of a table outlining acceptance criteria and reported device performance for an AI algorithm, nor can I detail specific ground truth establishment, sample sizes for training/test sets, or information regarding multi-reader multi-case studies, as this information is not present in the provided document.

The document focuses on demonstrating that modifications to an existing device (adding support for optional network and virtual reference features, and streamlining mid-procedure restart) do not raise new questions of safety or effectiveness, and that the subject device remains substantially equivalent to its predicate.

In summary, the document you provided does not describe the kind of AI performance study details you are asking for.

Ask a specific question about this device

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 IF1000 System software is modified to optionally receive an intra-procedural cone beam CT image to enhance the virtual target location based on user input.

The provided text is a 510(k) summary for the Intuitive Surgical Ion™ Endoluminal System (Model IF1000). This document focuses on demonstrating substantial equivalence to a predicate device (K202370) rather than presenting a detailed clinical study for a novel AI algorithm's performance against specific acceptance criteria.

Therefore, much of the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set and data provenance," "number of experts and their qualifications," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "ground truth for training set" is not explicitly available in the provided document.

The document primarily discusses software verification and validation, cybersecurity testing, and animal testing to demonstrate that the modified device is still substantially equivalent to the predicate device and performs as intended. It does not describe a clinical study measuring the performance of an AI-driven diagnostic or assistive algorithm against specific clinical endpoints or human expert performance.

Here's a breakdown of what can be gleaned from the text, and where information is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for clinical performance (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to software verification and validation, cybersecurity, and the general demonstration that the "design output meets the design input requirements" and "the System performs effectively according to its intended use."
• Reported Device Performance: Instead of performance metrics, the document reports:
  • "The software testing results demonstrate the System meets design specifications and user needs."
  • "The cybersecurity verification and validation test results demonstrate the adequacy of the implemented cybersecurity controls."
  • "The test results demonstrate that the System performs effectively according to its intended use and does not raise different questions of safety or effectiveness."

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

• Test Set Sample Size: Not specified for any performance evaluation in terms of patient numbers or clinical cases. The "animal testing" refers to an "in-vivo animal testing" but doesn't quantify the number of animals or trials.
• Data Provenance: The animal testing is described as a "simulated animal model." There's no mention of human patient data, its origin (country), or whether it was retrospective or prospective for performance testing.

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

• Not applicable/Discussed. This document does not describe a study where ground truth was established by human experts for the purpose of validating an AI's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Discussed.

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 MRMC study is described. The device assists in navigation and tool placement, it is not an AI diagnostic tool that human readers would interpret assisted by AI.

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

• The device is a system that "assists the user in navigating," implying human-in-the-loop operation. No standalone algorithm performance is described. The software V&V confirms the system meets design specifications, but not in terms of standalone clinical performance metrics.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not explicitly defined in the context of clinical performance. The validation relies on "design specifications," "user needs," and "intended use" verified through software testing and animal models.

8. The sample size for the training set:

• Not applicable/Discussed. This document is about a 510(k) submission for a modified device, not the development and training of a novel AI algorithm with a training set. The device uses "System Software" and "PlanPoint™ Software" but the document doesn't detail their development or training data.

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

• Not applicable/Discussed.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a modified medical device to a previously cleared predicate device. It does so by describing software verification and validation, cybersecurity testing, and limited animal testing to show the modifications do not raise new questions of safety or effectiveness. It does not provide the type of detailed performance study data typically associated with the rigorous evaluation of a novel AI algorithm against specific clinical acceptance criteria, expert ground truth, or human performance metrics.

Ask a specific question about this device

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 Model IF1000 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 Model IF1000 Instruments.

The provided document is a 510(k) summary for the Ion™ Endoluminal System (specifically the Ion™ Fully Articulating Catheter and the Ion™ Peripheral Vision Probe). The submission primarily focuses on changes to the reprocessing methods for these devices, introducing an alternative automated cleaning process and reducing rinsing steps for the existing manual cleaning process. It does not describe a study involving an AI algorithm in the traditional sense of diagnostic or predictive performance.

Therefore, the requested information regarding acceptance criteria and study details for AI performance (such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is largely not applicable to this document. The "device" in this context refers to the physical medical instruments, and the "performance" being evaluated is related to their reprocessability and safety after cleaning, not an AI's analytical capabilities.

However, I can extract the acceptance criteria and performance data related to the reprocessing validation and biocompatibility aspects, as these are the core performance assessments presented in this 510(k) summary.

Acceptance Criteria and Device Performance (Related to Reprocessing and Biocompatibility)

The device in question is the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter and Ion™ Peripheral Vision Probe). The study described relates to validating new reprocessing methods (automated cleaning and reduced manual rinsing steps) for these devices.

Due to the nature of this 510(k) submission, which focuses on device reprocessing validation, many of the typical AI-related study components (like expert ground truth, MRMC, training sets) are not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Reprocessing Validation (Cleaning Efficacy): The document does not specify the exact "sample size" in terms of number of devices tested for cleaning efficacy. It states that "AER equipment were validated" and "Testing was performed on the Model IF1000 devices subjected to the automated cleaning process."
• Biocompatibility (TOC Testing): Similar to reprocessing, the exact number of devices tested for TOC is not specified, but it was performed "on the Model IF1000 devices."
• Usability Testing: The document does not specify the number of users or sessions in the human factors study.
• Data Provenance: The studies described are prospective validation studies conducted by the manufacturer for the specific purpose of this submission. The origin of "data" in terms of patient information is not relevant here as these are laboratory and human factors studies, not clinical trials on patient data.

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

This information is not applicable as the "test set" in this context refers to devices undergoing reprocessing and human factors testing, not an AI algorithm being evaluated against expert-annotated medical image data. The "ground truth" for cleaning validation is objective laboratory measurement against standards, and for usability, it's successful task completion by trained users.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 typically apply to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document does not describe the evaluation of an AI algorithm assisting human readers. It focuses on the reprocessing of physical instruments.

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

No, a standalone algorithm performance study was not done. This submission does not pertain to an AI algorithm.

7. The type of ground truth used

• Reprocessing Validation: The ground truth for cleaning efficacy was established through objective laboratory measurements of residual soil levels (e.g., proteins, hemoglobin) against pre-defined limits, as guided by AAMI standards (TIR12, TIR30).
• Biocompatibility: The ground truth for biocompatibility was established through objective laboratory measurements of Total Organic Carbon (TOC) residuals, evaluated against acceptable limits defined by ISO 10993-1.
• Usability Testing: The ground truth was based on participants successfully and safely completing the specified reprocessing tasks as described in the updated instructions.

8. The Sample Size for the Training Set

This information is not applicable. This document does not describe an AI system, and therefore there is no "training set" in the context of machine learning.

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

This information is not applicable as there is no AI training set discussed in this document.

Ask a specific question about this device

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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