(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 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.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria. Instead, it describes a 510(k) summary for the "superDimension® Marker Delivery Kit," which is an accessory to an existing system. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with specific acceptance criteria.
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A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria or specific device performance metrics in the way one might expect for a new device undergoing extensive clinical trials. The focus is on demonstrating that the new accessory (Marker Delivery Kit) does not alter the fundamental safety and effectiveness of the existing superDimension i-Logic inReach System. The "Performance Test Summary-New Device" section states that the device and its instructions for use were subjected to the superDimension design control process, and "Risk Management was performed to analyze the potential hazards associated with the changes. 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." However, no quantitative criteria or reported performance values are given. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No specific test set or clinical study data are mentioned for the Marker Delivery Kit. The document explicitly states: "Clinical tests were not required to validate the changes to the superDimension System." This implies that the assessment of safety and effectiveness was primarily based on non-clinical engineering and risk management activities, and comparison to the predicate device. -
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):
Since no clinical test set or study is described, there is no mention of experts establishing a ground truth. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set is described, there is no mention of an adjudication method. -
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:
No MRMC study was mentioned. The device described is a medical instrument (marker delivery kit) and guiding system, not an AI-assisted diagnostic tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical marker delivery kit used with a bronchoscope guidance system, not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No ground truth determination is discussed in the context of device performance, as the submission relies on substantial equivalence and non-clinical testing. -
The sample size for the training set:
No training set is mentioned as clinical data were not required for this submission. -
How the ground truth for the training set was established:
Not applicable, as no training set is discussed.
§ 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.