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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The superDimension i·Logic inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension i·Logic inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery. superDimension is introducing the Edge Catheter System for use with the superDimension i·Logic inReach System. The i·Logic inReach System accomodates both the Edge Catheter and the currently available inReach Catheter System.

This 510(k) submission (K102604) for the superDimension® i·Logic™ inReach® System with Edge™ Catheter is a Special 510(k), which indicates a modification to an already cleared device. For such submissions, the FDA typically relies on design control processes, risk management, and verification/validation activities rather than new clinical trials to demonstrate substantial equivalence, especially when the fundamental scientific technology and intended use remain the same.

Therefore, the provided document explicitly states: "Clinical tests were not required to validate the changes to the superDimension inReach System."

This means that the submission does not include a detailed study proving the device meets specific acceptance criteria through a clinical trial or performance study comparing it against predefined metrics. Instead, the justification for meeting acceptance criteria is based on:

• Design Control Process: The Edge Catheter System, i·Logic inReach Software, and Instructions for Use were subjected to the superDimension design control process.
• Risk Management: Risk management was performed to analyze potential hazards associated with the changes.
• Design Verification and Validation: Appropriate design verification and validations were performed to assure the superDimension i Logic inReach System continues to be safe and effective for its intended use.

Since no clinical study data is provided in the document, I cannot fill in the table or answer questions related to sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance, or training set details. The acceptance criteria themselves are implicitly met through the "safe and effective for its intended use" statement, supported by the design control process rather than quantitative performance metrics from a new clinical study in this specific 510(k).

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The superDimension inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.

The submission indicates that the superDimension inReach System, with its updated software functionalities (autoIR and dynamic registration algorithms, new views, and continuous pathway guidance), continues to be safe and effective for its intended use. However, it explicitly states that clinical tests were not required to validate these changes. Therefore, the document does not contain information about acceptance criteria, performance metrics, or study details.

Since no clinical study was conducted for this specific submission to demonstrate the device meets acceptance criteria, I cannot provide the requested information in the table format or answer the questions related to clinical study design, sample size, ground truth establishment, or multi-reader multi-case studies.

The provided document {0}-{4} details a 510(k) submission (K092365) for the superDimension inReach™ System, focusing on software functionality additions.

Here's a breakdown of what is and is not present in the document regarding acceptance criteria and performance studies:

What the document states about performance:

• Performance Data: "The changes to the algorithms and Instructions for Use were subjected to the superDimension design control process. Risk Management was performed to analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the superDimension inReach System continues to be safe and effective for its intended use."
• Clinical Data: "Clinical tests were not required to validate the changes to the superDimension inReach System."
• Conclusion: "The superDimension inReach System is safe and effective for its intended use."

Based on this, the requested information cannot be fully provided because the submission explicitly states that clinical tests were not required to validate the changes. Therefore, there is no clinical study described in the document that proves the device meets specific acceptance criteria based on human performance or outcome metrics.

Nevertheless, I will

• provide a table of acceptance criteria and the reported device performance.
• indicate what type of performance data and studies were provided.
• indicate what type of performance data and studies were not provided.

Acceptance Criteria and Device Performance

Detailed breakdown of requested information:

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

   • Acceptance Criteria: The document does not explicitly list specific numerical acceptance criteria for clinical performance because clinical tests were not required. The overall implicit acceptance criterion is that the modified device remains "safe and effective for its intended use," as determined through design control, risk management, and design verification/validation processes.
   • Reported Device Performance: The document states that the changes were subjected to design control, risk management, and appropriate design verification and validations to assure continued safety and effectiveness. No specific performance metrics (e.g., accuracy, sensitivity, specificity, or navigation precision values) are provided in this summary.

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

   • Not Applicable. The document explicitly states, "Clinical tests were not required to validate the changes to the superDimension inReach System." Therefore, there is no test set, corresponding sample size, or data provenance from a clinical study described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not Applicable. As no clinical test set was required or performed, there were no experts used to establish ground truth for such a set described in this document.

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

   • Not Applicable. No clinical test set.

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:

   • Not Applicable. The document does not describe any MRMC or comparative effectiveness study. The device provides "guidance" tools but is not an AI for diagnosis or interpretation that would typically require such a study to measure reader improvement.

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

   • The submission mentions "implementation of algorithms for CT-to-Body Automatic Initial Registration (autoIR) and dynamic registration (DR)". While "design verification and validations" were performed on these algorithms, the document does not specify if standalone, algorithm-only performance studies (e.g., measuring registration accuracy or robustness purely on data without human interaction) were conducted, nor does it provide results from such studies if they were performed as part of the broader "design verification and validations."

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

   • Not Applicable for clinical performance. For the non-clinical "design verification and validations" mentioned, the type of ground truth would typically relate to engineering standards, phantom studies, or simulated data for assessing algorithm accuracy (e.g., comparing algorithm-reported position to a known true position in a controlled setup), but this is not detailed in the summary.

8. The sample size for the training set:

   • Not Applicable / Not provided. The document describes "algorithms" (autoIR and DR) but does not provide information about how these algorithms were developed or if they involved machine learning with a distinct training set. If they are rule-based or conventional algorithmic approaches, a "training set" in the machine learning sense might not be applicable.

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

   • Not Applicable / Not provided. No information on algorithm development or training set ground truth is included.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The inReach System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The inReach System also enables the placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.

This 510(k) submission (K081379) is for a Special 510(k) change to an existing device, the superDimension inReach System. This means the submission focuses on demonstrating that modifications made to the device do not alter its fundamental safety or effectiveness. As such, the performance data provided is related to software validation and risk analysis rather than a clinical study evaluating diagnostic performance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a Special 510(k) for software modifications, the "acceptance criteria" are related to software validation and ensuring the updated system still meets its intended use, rather than a clinical performance metric like sensitivity or specificity.

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

The document states, "Clinical tests were not required to validate the changes to the inReach System." Therefore, there is no test set of clinical data (patients/images) used for performance evaluation in this specific 510(k) submission. The testing would have been internal software validation and verification.

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

As no clinical test set was used for performance evaluation, no experts were used to establish ground truth for a clinical test set in this submission.

4. Adjudication Method for the Test Set

Since no clinical test set was used, no adjudication method was applied.

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

No MRMC comparative effectiveness study was done as clinical tests were not required. The submission focuses on software modifications and their impact on functionality, not on human reader performance improvement.

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

No standalone clinical performance study was done as clinical tests were not required. The "performance data" refers to software validation and risk analysis.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the software validation performed, the "ground truth" would be against defined software requirements and specifications. For instance, a function designed to generate a 3D-Map view would be tested to ensure it accurately generates the map as per its design specifications. This is not clinical ground truth.

8. The Sample Size for the Training Set

The document does not mention any machine learning or AI components that would require a "training set" of data. The software modifications are described as enhancements to GUI, 3D-pathway planning, and navigation capabilities. Thus, no training set of data is applicable or mentioned.

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

As no training set was used, this point is not applicable.

In summary, this 510(k) submission is for minor software modifications to an already cleared device. The "study" proving the device meets acceptance criteria consists of software validation, risk analysis, and design validations, which are standard procedures for such changes, rather than a clinical efficacy study with patient data.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The superDimension/Bronchus System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The superDimension/Bronchus also enables the placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.

The provided 510(k) summary (K080271) for the superDimension/Bronchus inReach™ System does not contain a study that proves the device meets specific acceptance criteria with reported performance metrics. Instead, it is an indication expansion for an already cleared device, where the key change is an update to the Instructions for Use (IFU) to include guidance for deploying radiosurgical and dye markers into soft lung tissue.

Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this particular 510(k) submission as it focuses on software or algorithm performance. The submission explicitly states:

• "Clinical tests were not required to validate the changes to the superDimension/Bronchus System."
• "No changes are being made to the hardware or software design, or technological characteristics of the current marketed device."

The basis for the expanded indication is:

• "Multiple published studies have demonstrated the Bronchus is safe and effective when used to place radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery." (However, these studies are not detailed or provided within this K080271 submission.)
• A hazard analysis and appropriate design validations were performed to assure the device continues to meet expanded user needs.

Because this 510(k) is an indication expansion based on existing evidence and no new performance data or clinical studies were submitted, most of the requested fields cannot be filled.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission does not detail specific acceptance criteria for device performance or report new performance data as part of this K080271 submission. The changes pertain to expanded indications for use based on the existing device's established safety and effectiveness.

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

Not applicable. No new test set data was generated or submitted for this indication expansion.

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

Not applicable. No new test set requiring ground truth establishment was conducted for this submission. The claim refers to "Multiple published studies" but does not detail their methodology or expert involvement within this document.

4. Adjudication Method for the Test Set:

Not applicable. No new test set requiring adjudication was conducted for this submission.

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

No. An MRMC comparative effectiveness study was not done as part of this submission. The submission states, "Clinical tests were not required to validate the changes to the superDimension/Bronchus System."

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

Not applicable. The superDimension/Bronchus System is a guidance system for human-operated bronchoscopes and tools; it is not a standalone diagnostic or completely autonomous device in the context of this submission. No new algorithm-only performance studies were conducted.

7. The Type of Ground Truth Used:

Not applicable for this submission. The reliance is on "Multiple published studies" which would have established their own ground truth based on clinical outcomes, pathology, or direct observation, but these are not detailed here.

8. The Sample Size for the Training Set:

Not applicable. This submission is not about developing or training a new algorithm or AI model; it's an indication expansion for an existing device.

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

Not applicable. This submission is not about developing or training a new algorithm or AI model.

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