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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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