(132 days)
The SPIN Thoracic Navigation System is a stereotactic accessory for Computed Tomography (CT) and endosopic bronchoscope systems. The SPiN Thoracic Navigation System is indicated for displaying:
· An interventional instrument such as a biopsy needle, an aspiration needle on a computer monitor that also displays a CT-based model of the target organ(s).
· Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract.
The SPiN Thoracic Navigation System compensates for the patient's respiratory phases.
The SPIN Thoracic Navigation System is in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.
The SPiN Thoracic Navigation System enables marker placement in soft lung tissue.
The SPiN Thoracic Navigation System is an accessory for a CT system that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CT-based model of the tracheobronchial tree. Due to system use to locate structures in soft tissue. the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The SPiN Thoracic Navigation System consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary pathway reconstruction and planning workstation. The EM tracking accessories that can be used with the SPiN Thoracic Navigation System include Veran's Always-On Tip Tracked™ Guidewire, Sheath, Aspiration Needle, Brush, Forceps or View Peripheral Catheter. The SPiN Thoracic Navigation System also enables the placement of markers in soft tissue to guide radiosurgery and thoracic surgery. The SPiN View console/View Optical Probe is provided as an additional accessory for video visualization and is a complement to the EM tracking of the View Peripheral Catheter, enhancing the navigation of the device through the vocal chords and tracheobronchial tree.
Here's a summary of the acceptance criteria and the study information for the SPiN Thoracic Navigation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Software Verification & Validation | The SPiN Drive and SPiN Planning software applications successfully fulfilled the requirements defined in the Software Requirement Specifications and Software Design Specifications. |
| Navigational Accuracy (Static Phantom) | Testing results met the predetermined acceptance criteria established in test protocols. (Specific accuracy metrics are not provided in this document). |
| Electrical Safety (System) | Met all requirements of AAMI/ANSI/IEC 60601-1. |
| Electromagnetic Compatibility (System) | Met all requirements of IEC 60601-1-2. |
| Electrical Safety (Endoscopic Equipment) | The SPiN View console met all requirements of IEC 60601-2-18. |
| Laser Classification (SPiN View System) | Classified as a Class 3R laser light source, which is "safe if handled correctly with restricted beam viewing" with a "low risk of injury" for exceeding the maximum permissible exposure (MPE). (Safety confirmed, not a specific performance metric but a classification result). |
| EO Sterilization Validation | All instrumentation can be appropriately sterilized to the currently validated ethylene oxide sterilization cycle. |
| Biocompatibility of EO Sterilized Instruments | No biocompatibility issues exist with the instrumentation. |
| Functional Testing of Instrumentation | Demonstrated the durability of the instrumentation. |
| Video Visualization Accessory V&V | The video visualization system met all established requirements. |
| View Optical Probe Accessory Functional Testing | All established requirements were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of human subjects or patient data. The performance evaluations described are primarily focused on system-level testing, phantom studies, and accessory validation.
- Test Set (Phantom): Used a "static phantom" for navigational accuracy testing. The number of samples/runs on the phantom is not specified.
- Data Provenance: The document does not provide information about the country of origin of data or if it was retrospective or prospective, as the testing described focuses on device performance rather than patient studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the context of clinical interpretation or diagnostic accuracy. The ground truth for the technical performance tests (e.g., electrical safety, EMC, sterilization, phantom accuracy) would be defined by engineering specifications and objective measurements against those specifications.
4. Adjudication Method (for the test set)
No adjudication method is described, as the testing outlined is technical verification and validation against objective criteria rather than subjective human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on the technical performance and safety of the device itself, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The document describes "Software verification and validation testing" which evaluated the algorithms' performance in fulfilling requirements and demonstrating navigational accuracy on a static phantom. This constitutes a standalone performance evaluation of the algorithms and system components in a controlled environment.
7. Type of Ground Truth Used
The ground truth used for the described studies is primarily:
- Engineering Specifications/Requirements: For software, electrical safety, EMC, and overall system functionality, the ground truth is defined by the established technical specifications and regulatory standards (e.g., IEC 60601 series).
- Physical Measurements: For navigational accuracy, the ground truth would be precise physical measurements on the static phantom.
- Laboratory Analysis: For sterilization and biocompatibility, the ground truth is determined by validated laboratory test methods and results (e.g., confirming sterility, assessing material compatibility).
8. Sample Size for the Training Set
The document does not provide information on the sample size for any training set for machine learning models. The device relies on electromagnetic tracking technology, not explicitly stated machine learning models that would require a "training set" in the conventional sense of AI development for image interpretation. The software development process mentioned involves "Software Requirement Specifications" and "Software Design Specifications," which guide traditional software engineering.
9. How Ground Truth for the Training Set Was Established
As no training set for machine learning is explicitly mentioned, the establishment of ground truth for a training set is not applicable to the information provided.
§ 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.