(167 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™ navigation 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™ navigation 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.
This document is a 510(k) premarket notification for the superDimension Navigation System, specifically for software release version 7.1. It details the substantial equivalence to a predicate device and the testing performed.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in the format typically seen for algorithms with quantitative outputs (e.g., sensitivity, specificity, accuracy against a numerical threshold). Instead, the "acceptance criteria" are implied through the design verification and validation processes.
The reported performance is qualitative and focused on the successful execution of tasks and compliance with specifications:
| Acceptance Criteria (Implied) | Reported Performance |
|---|---|
| Conformance to product specification and system requirements | "Design verification performed on the superDimension system V7.1 Planning and Procedure application and confirmed that the superDimension navigation system met its product specification and system requirements." |
| "A full regression testing was executed to verify the modifications and ensure that the superDimension navigation system meets its product specification and requirements." | |
| Conformance to defined user needs and intended uses (under simulated use) | "100 % of users across the three categories (bronchoscopists, clinicians, and service personnel.) successfully completed validation tasks." |
| "In conclusion, the design validation study ensured that the Version 7.1 superDimension™ Navigation System with planning and procedure software version 7.1, conform to defined user needs and intended uses." | |
| Safety and Effectiveness of the Device (following changes) | "Design verification and validation test results demonstrate that the changes don't affect the safety and effectiveness of the device as the subject device conforms to the requirements and specifications of the device." |
| Compliance with ISO 14971:2007 (Risk Management) | "The superDimension navigation system is in compliance with the following International and FDA-recognized consensus standard: ISO 14971: 2007 Medical Devices - Application of Risk Management to Medical Devices" |
2. Sample size used for the test set and the data provenance
- Test set sample size: The document does not specify a numerical sample size for the "test set" in terms of patient data or CT scans. The testing described focuses on the software's functionality and user interaction rather than its performance on a dataset of clinical cases. The "test set" for design validation involved representative users (bronchoscopists, clinicians, and service technicians) performing "typical use scenario defined in the design validation protocol." However, the exact number of users is not stated, nor is the number of scenarios or cases they performed.
- Data provenance: Not applicable in the traditional sense of a clinical dataset for an AI algorithm (e.g., retrospective/prospective patient data from specific countries). The validation was conducted under simulated use conditions at Covidien LLC facilities in Plymouth, MN (USA) and Herzliya, Israel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not directly applicable in the context of this device's validation as described. The validation was a functional and user-experience validation, not an assessment of an AI algorithm's diagnostic accuracy against a "ground truth" derived from expert consensus. The "experts" involved were the "representative users" who participated in the design validation:
- Qualifications: "qualified bronchoscopists, clinician, and service technicians."
- Number of experts: The specific number is not provided, only stating "representative users from each targeted user group."
4. Adjudication method for the test set
Not applicable. The validation involved users successfully completing tasks, rather than an adjudication process for a diagnostic outcome. The success was evidently unanimous ("100 % of users... successfully completed validation tasks"), suggesting no need for adjudication for disagreement.
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
No, an MRMC comparative effectiveness study was not conducted or described. The device is a navigation system that aids in guiding tools, not an AI intended to improve human reader diagnostic accuracy (e.g., in reading images). The changes described are software enhancements for planning and procedure, not a new AI diagnostic component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the device as described. The superDimension Navigation System is an interactive system designed to be used by a human (physician) to guide tools. It is not a standalone algorithm that provides a diagnosis or output without human interaction. The validation focused on the system's functionality and its successful use by humans.
7. The type of ground truth used
The "ground truth" was the pre-defined successful completion of "typical use scenarios" and conformance to product specifications and user needs. This is essentially a functional and user-acceptance "ground truth" for a medical device software modification, rather than a clinical ground truth like pathology, expert consensus on imaging, or outcomes data, which would be typical for a diagnostic AI.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning or AI models. The software modifications are described as "software features" and "minor software enhancements," suggesting traditional software development and testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned.
§ 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.