(30 days)
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
| Acceptance Criteria (Not Explicitly Stated for Clinical Performance) | Reported Device Performance (as per document) |
|---|---|
| Safety and Effectiveness for Intended Use | Claim: The superDimension inReach System is "safe and effective for its intended use." |
| Algorithm Functionality (autoIR, DR) | Changes subjected to design control process; appropriate design verification and validations performed. |
| New Views (LG tip indicator, local view, virtual bronchoscopy, MIP) | Changes subjected to design control process; appropriate design verification and validations performed. |
| Continuous Pathway Guidance | Changes subjected to design control process; appropriate design verification and validations performed. |
Detailed breakdown of requested information:
-
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.
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set.
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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.
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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."
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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.
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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.
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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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.