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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 LungPoint Software is a device that guides a bronchoscope and commercially available endoscopic tools to a prespecified target in or adjacent to the bronchial tree by providing a path, which is displayed on a 3D reconstruction of a CT scan. The Software allows visualization of the interior of the bronchial tree; placement of catheters in the bronchial tree; visualization of a prespecified target in lung tissue; and placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. The FlexNeedle is an aspiration needle. When used together with the LungPoint Software, the needle can be guided to a prespecified targeted area within the respiratory organs.

The software is installed on an off-the-shelf PC computer system, and is intended to be used with commercially-available flexible bronchoscopes with CT scans that are saved in DICOM format.

The provided text is a 510(k) summary for the LungPoint™ Planning and Virtual Bronchoscopic Navigation (VBN) Software. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria and specific statistical results.

Therefore, many of the requested details about acceptance criteria, performance data, test set characteristics, expert qualifications, and ground truth establishment are not explicitly available in the provided text.

Here's an analysis based on the information that is present:

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

The document states: "No new risks were identified as the use of endoscopic tools, like the FlexNeedle, is inherent to the design and intended use of the existing LungPoint Software. Additionally, no new verification and validation testing was performed as the software was not modified in any way to allow for the use of the FlexNeedle."

This indicates that the primary "acceptance criterion" for this specific 510(k) submission was the absence of new risks or modifications to the software that would necessitate new performance testing. Therefore, there is no direct table of acceptance criteria and reported device performance for this submission. The performance of the underlying LungPoint Software would have been established in previous 510(k) clearances (K091160).

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

This information is not provided in the text, as no new performance testing was conducted for this specific submission.

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)

This information is not provided in the text, as no new performance testing was conducted for this specific submission.

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

This information is not provided in the text, as no new performance testing was conducted for this specific 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

There is no mention of an MRMC comparative effectiveness study or AI assistance in the provided text. The device is described as "guid[ing] a bronchoscope... by providing a path, which is displayed on a 3D reconstruction of a CT scan." This suggests a visualization and navigation tool rather than an AI-assisted diagnostic tool.

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

No standalone performance study is mentioned in the text for this submission. The device is explicitly intended to "aid the physician in guiding endoscopic tools," indicating a human-in-the-loop design.

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

This information is not provided in the text, as no new performance testing was conducted for this specific submission.

8. The sample size for the training set

This information is not provided in the text, as no new performance testing was conducted for this specific submission. The device is not described as being based on machine learning or requiring a "training set" in the context of this 510(k).

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

This information is not provided in the text, as no new performance testing was conducted for this specific submission and the device's mechanism isn't described as requiring a training set in this context.

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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/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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