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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.

superDimension is proposing that the inReach™ Planning Laptop, with its current software be approved to be used either as a stand-alone for performing bronchoscopy planning, as currently approved (K081379, June 11, 2008) or for CT-Viewing, or with the other system components in places outside of the endoscopy room.

There are no modifications proposed to the software, firmware, firmware, product design or specifications, or manufacturing processes as currently approved.

This 510(k) summary explains that the submission K062386 is for a minor modification to an already approved device (inReach™ Planning Laptop, K081379). The proposed modification is to allow the device to be used as a stand-alone unit for bronchoscopy planning and CT-viewing, or with other system components, outside of the endoscopy room.

Crucially, the document states: "There are no modifications proposed to the software, firmware, firmware, product design or specifications, or manufacturing processes as currently approved." and "No changes are being made to the hardware or intended use, or technological characteristics of the current marketed device."

Therefore, based on the provided text, there are no new acceptance criteria or new studies conducted to prove the device meets new criteria because the device itself and its performance characteristics are not changing. The provided text indicates that the original performance data and studies from the predicate device (K081379) are considered sufficient.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Since no new modifications to the software, hardware, or performance are being made, no new acceptance criteria or performance data for this specific 510(k) submission (K062386) are presented. The document relies on the previous approval (K081379).

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

No new test set was used for this submission (K062386). The changes are administrative regarding usage context, not performance.

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

Not applicable, as no new test set was used.

4. Adjudication Method for the Test Set:

Not applicable, as no new test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted for this submission (K062386). The document explicitly states: "Clinical tests were not required to validate the changes to the inReach System to include the Planning Laptop."

6. Standalone Performance Study:

No new standalone performance study was conducted for this submission (K062386). The device's performance, whether standalone or integrated, is considered unchanged from its previous approval.

7. Type of Ground Truth Used:

Not applicable, as no new performance studies were conducted for this submission.

8. Sample Size for the Training Set:

Not applicable, as no new training was performed for the device's algorithmic components (since the software is unchanged).

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

Not applicable, as no new training was performed for the device's algorithmic components (since the software is unchanged).

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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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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The superDimension/Bronchus Premium 2 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 provided text is a 510(k) summary for the superDimension/Bronchus Premium 2 device, dated July 12, 2007. It describes changes made to an already cleared device (K062315).

Based on the document, the following observations can be made regarding acceptance criteria and the study:

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

The document states: "Appropriate verification and validation tests were performed to assure that the design output met the design input requirements and that the modified device continues to meet its user needs and intended uses." However, specific quantitative acceptance criteria and reported device performance are not detailed in this 510(k) summary. This summary focuses on the administrative aspects of a special 510(k) and asserts that the device continues to meet its previous requirements rather than establishing new ones or reporting specific performance metrics for the modified device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document explicitly states: "Clinical tests were not required to validate the changes made to the superDimension/Bronchus Premium 2." This indicates that no new clinical test data was generated, and therefore, there is no sample size for a test set or data provenance to report from this specific submission. The submission relies on the substantial equivalence to the predicate device and the verification and validation (V&V) activities against design inputs for the modified components.

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):

As no clinical tests were required, no experts were used to establish ground truth for a test set related to this submission.

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

Since no clinical tests were required, there was no adjudication method employed for a test set in this submission.

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:

The device described is a navigation system for bronchoscopy, not an AI or imaging interpretation device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device, and there is no mention of AI assistance or its effect size.

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

This device is not an algorithm that performs standalone analysis. It is a system that aids a physician in guiding endoscopic tools. Therefore, no standalone algorithm-only performance study was conducted.

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

As no clinical testing was performed for this specific 510(k) submission, no new ground truth data was generated or used. The assessment relies on the existing clearance of the predicate device and the V&V activities.

8. The sample size for the training set:

The document does not describe any machine learning or AI components that would require a training set. Therefore, no sample size for a training set is provided.

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

As there is no mention of a training set, the question of how its ground truth was established is not applicable to this document.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

The superDimension/Bronchus Premium 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 target and the interior of the tree. It has been modified to permit connection to PACS and import of PET/CT image data. Other minor improvements have been made also.

The provided text states, "Since no new technology is used, clinical tests are not required." Therefore, the device did not undergo clinical testing to establish acceptance criteria or demonstrate performance.

Here's a breakdown of the requested information based on the provided document, even though a clinical study fulfilling these criteria was not conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. No acceptance criteria or performance metrics derived from clinical trials are mentioned.

2. Sample Size for Test Set and Data Provenance

Not applicable. No clinical test set.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. No ground truth established from expert review in a clinical study.

4. Adjudication Method

Not applicable. No clinical test with adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was performed or reported.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a guidance system, and the document explicitly states "It does not make a diagnosis and is not a bronchial tool." It's not an AI algorithm performing a diagnostic task in a standalone manner.

7. Type of Ground Truth Used

Not applicable. No clinical ground truth was established through expert consensus, pathology, or outcomes data as clinical tests were not required.

8. Sample Size for the Training Set

Not applicable. This device is a guidance system, not an AI algorithm trained on a dataset.

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

Not applicable. No training set for an AI algorithm.

Summary of Device Information provided in the text:

• Device Name: superDimension/Bronchus Premium 2
• Intended Use: To image the upper airways and tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not a bronchial tool.
• Modifications from Predicate: Modified to permit connection to PACS and import of PET/CT image data. Other minor improvements.
• Performance Data: Non-clinical tests included satisfying EN60601-1 and EN 60601-1-2 requirements and extensive bench testing.
• Reason for no Clinical Tests: "Since no new technology is used, clinical tests are not required." This indicates that the FDA deemed the changes to the device minor enough that new clinical data was not necessary to demonstrate substantial equivalence to the predicate device (superDimension/Bronchus Premium, K052852).

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

The superDimension/Bronchus Premium 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 nearnet aod the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.

The provided text describes the superDimension/Bronchus Premium device but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The document is a 510(k) summary for a Special 510(k), which implies that the device is substantially equivalent to a previously cleared device (superDimension/Bronchus 4.1, K052260) and incorporates minor modifications.

Here's a breakdown of why the requested information is absent based on the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not present. The document states, "Since no new technology is used, clinical tests are not required." This indicates that the device's performance was not evaluated through a new clinical study with pre-defined acceptance criteria, but rather by demonstrating substantial equivalence to a predicate device.
• Sample size for the test set and data provenance: No test set is mentioned because no new clinical testing was deemed necessary.
• Number of experts and their qualifications: Not applicable as no new ground truth establishment process is described.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
• Standalone (algorithm only) performance: Not applicable, as this is a device for guiding a bronchoscope, not a diagnostic algorithm.
• Type of ground truth used: Not applicable as no new clinical study to establish ground truth was performed.
• Sample size for the training set: Not applicable as "no new technology is used."
• How the ground truth for the training set was established: Not applicable.

Summary from the provided text:

Reasoning for "Not applicable":

The document explicitly states: "Since no new technology is used, clinical tests are not required." This means that the device's clearance was based on its substantial equivalence to a predicate device, rather than new clinical data demonstrating its performance against specific acceptance criteria. The modifications were minor, primarily allowing external video monitoring/recording and other minor improvements. Therefore, the detailed information about clinical studies, test sets, ground truth establishment, and expert involvement is not present in this 510(k) summary.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

The superDimension/Bronchus 4.1 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 target and the interior of the tree.

The information provided indicates that no clinical studies were performed for the superDimension/Bronchus 4.1 device due to its classification as not using new technology. Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available in the given text.

Here's a breakdown of the available information and the details that are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: No clinical test set was used.

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

• Not Applicable: No clinical test set was used.

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

• Not Applicable: No clinical test set was used.

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: No MRMC study was performed as no clinical studies were conducted. The device (superDimension/Bronchus 4.1) is a tool to guide a bronchoscope, not an AI for interpretation or improvement of human reader performance.

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

• Not Applicable: The device is a guidance system for endoscopic tools, not a standalone diagnostic algorithm. No standalone performance study was mentioned.

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

• Not Applicable: Since no clinical studies were performed, no ground truth types were established from patient data. The "ground truth" for non-clinical testing refers to meeting technical standards (EN60601-1 and EN 60601-1-2) which are objective engineering specifications.

8. The sample size for the training set

• Not Applicable: No training set for an algorithm was mentioned, as "no new technology is used" and no clinical studies were conducted. The device is a guidance system, not an AI/machine learning algorithm that requires a training set.

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

• Not Applicable: No training set was used.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

The superDimension/Bronchus is a device that guides a bronchoscope and bronchial tool to a target in the bronchial tree on a path indicated by CT scan, and to visualize the interior of the tree and target

Here's an analysis of the provided text regarding the superDimension/Bronchus device, focusing on acceptance criteria and study details.

Based solely on the provided text, there is very limited information about specific acceptance criteria or a detailed clinical study demonstrating the device meets those criteria. The submission is a 510(k) summary, which often provides high-level information.

Here's a breakdown of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The document states that the device meets these criteria rather than defining specific thresholds or metrics for the criteria (e.g., "guiding accuracy must be within X mm"). This is common in 510(k) summaries which declare substantial equivalence rather than presenting detailed performance specifications.

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

• Sample Size: The document does not specify the sample size for the clinical evaluation (test set), nor does it break down the number of animal subjects. It only states "animal tests" and "a clinical evaluation."
• Data Provenance: The document doesn't specify the country of origin for the clinical data. It does state that superDimension Ltd. is located in Herzliya, Israel, which might imply the study was conducted there, but this is not explicitly stated for the clinical evaluation. It also doesn't explicitly state if the data was retrospective or prospective.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

• The adjudication method is not specified in the document.

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

• There is no mention of an MRMC comparative effectiveness study in the provided text.
• Therefore, no effect size for human readers improving with AI vs. without AI assistance can be determined from this document.

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

• The device's intended use is to "aid the physician in guiding endoscopic tools," implying a human-in-the-loop system. The document does not describe any "standalone" performance evaluation of the algorithm without human intervention. Its stated purpose is as a guidance tool, not an autonomous diagnostic or procedural tool.

7. The Type of Ground Truth Used

• The document does not explicitly state the type of ground truth used for its "clinical evaluation" or "animal tests." Given the device's function as a guidance system for the tracheobronchial tree, potential ground truths could include:
  • Direct visualization/localization: Confirmation of tool tip position relative to the target using a reference standard (e.g., fluoroscopy, repeat CT scan with markers, direct visual confirmation if accessible).
  • Pathology/Biopsy results: If the guidance was for biopsy, the success of reaching a lesion later confirmed by pathology might be an indirect measure.
  • Expert Consensus: Clinical assessment by experienced bronchoscopists regarding the accuracy and ease of guidance.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a "training set" or its sample size. This is a pre-market submission for a device, not a detailed paper about algorithm development. It's likely that the product integrates software and algorithms, but the specifics of their development and training are not disclosed here.

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

• Since there's no mention of a training set or its sample size, there's also no information on how its ground truth was established.

Summary of Missing Information:

This 510(k) summary provides a high-level overview focused on establishing substantial equivalence. It lacks the granular detail about clinical study design, specific performance metrics, ground truth establishment, or expert involvement that would typically be found in a detailed clinical report or peer-reviewed publication. The "Performance Data" section indicates that tests were done and standards met, but not the specifics of how these were measured or the quantitative results beyond a general conclusion of safety and effectiveness.

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