(297 days)
The iNod Ultrasound Guidance Console is intended to be used with iNod Ultrasound Guided Biopsy Needle, to observe and to store real-time ultrasound images of endobronchial lesions, peripheral lung nodules, or lung masses located in airways and tracheobronchial tree.
The iNod Ultrasound Guided Biopsy Needle is intended for use through a flexible bronchoscope for intraluminal sonographic imaging in the tracheobronchial tree and retrieval of specimens with endobronchial lesions, peripheral lung nodules, or lung masses.
The proposed iNod Ultrasound Guidance System (iNod System), comprises: the sterile, single use iNod Ultrasound Guided Biopsy Needle (also referred to as iNod Single Use Device (SUD), iNod Ultrasound Guidance Console (iNod Console) and the iNod Motor Drive Unit (iNod MDU). The proposed iNod Ultrasound Guidance System is intended to perform pulmonary needle biopsy under real-time visualization using Radial Endobronchial Ultrasound (R-EBUS).
The iNod single-use-device (iNod SUD) is a single use, sterile device that has combined functionality of a radial ultrasound probe and a biopsy needle. The iNod SUD allows real-time visualization of pulmonary lesions with radial ultrasound, while simultaneously allowing biopsy of the pulmonary lesions. The three main parts of iNod SUD are a handle, a radial ultrasound transducer, and biopsy needle. The biopsy needle is actuated at an angle that allows biopsy of eccentric and concentric nodules. A stainless-steel needle indicator strip is housed in the imaging window at distal tip, which provides an ultrasound signature, indicating the orientation of the needle to the user in the ultrasound image. The biopsy needle will exit the iNod SUD distal tip at 180 degrees relative to the needle indicator position visible in the ultrasound image. Once the needle is positioned to biopsy a nodule, the needle is unlocked by user to the exit ramp at 11° angle. Finally, when a sample is collected, the Nitinol stylet can be passed down the needle lumen to expel the sample.
The iNod Console is an electronic device that consists of:
- The iNod MDU, which rotates the ultrasound transducer in the iNod SUD to generate 360° images as well as provides patient isolation from the rest of the Console components.
- A software-based touchscreen tablet with battery, which can be mounted to a mobile pole yia . the pole docking station.
- A software-based Acquisition PC that interprets the received ultrasound signals from the iNod SUD and generates the image that is displayed on the tablet.
- Functionality that displays ultrasonic image received from iNod SUD through iNod MDU and Acquisition PC on the iNod tablet and
- . Ability to save and export procedure images and recordings.
The iNod MDU provides rotation of the iNod SUD's ultrasound transducer, required for generating a 360° ultrasound image. An electromechanical connector interface at the proximal end of the iNod SUD makes the connection to the MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection. The iNod Console interfaces with the iNod SUD through the iNod Motor Drive Unit (iNod MDU), which provides the electromechanics for the rotating parts of the imaging catheter, and the interface between the iNod SUD and the iNod console. The iNod MDU is nearly identical in design to its predicate MDU5 Plus, which is currently used with Avvigo Guidance System II (K212490).
The information provided describes the acceptance criteria and a summary of the performance testing for the iNod Ultrasound Guidance System. However, it does not include details about a clinical study involving human subjects or AI performance. The provided document focuses entirely on bench testing and software verification without reporting any clinical efficacy or comparative effectiveness against human readers. Therefore, several requested sections, particularly those related to human reader studies, ground truth establishment for a test set, and MRMC studies, cannot be addressed from the given text.
Here's the information extracted and organized based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Product Specification" in the table, and the reported performance is simply "Pass" for all criteria. Specific numerical acceptance limits are not detailed for each specification in the provided document, but the outcome indicates they were met.
| Component | Product Specification | Reported Device Performance |
|---|---|---|
| iNod SUD | Device Passability | Pass |
| iNod SUD | Device Rotation | Pass |
| iNod SUD | Needle Actuation Force | Pass |
| iNod SUD | Needle Extension Length | Pass |
| iNod SUD | Needle Angle | Pass |
| iNod SUD | Needle Outer Diameter | Pass |
| iNod SUD | Needle Inner Diameter | Pass |
| iNod SUD | Needle Sharpness | Pass |
| iNod SUD | Needle Aspiration | Pass |
| iNod SUD | Stylet Removal Force | Pass |
| iNod SUD | Stylet Kink Resistance | Pass |
| iNod SUD | Catheter Working Length | Pass |
| iNod SUD | Handle to Catheter Tensile | Pass |
| iNod SUD | Drive Cable to Handle Tensile | Pass |
| iNod SUD | Drive Cable to MDU Connector Tensile | Pass |
| iNod SUD | Device Reliability | Pass |
| iNod SUD | Pulse Echo Sensitivity | Pass |
| iNod SUD | Pulse Echo Bandwidth | Pass |
| iNod SUD | Pulse Echo Center Frequency | Pass |
| iNod SUD | Pulse Echo Pulse Length | Pass |
| iNod SUD | Acoustic Output | Pass |
| iNod SUD | NURD (Non-Uniform Rotation Distortion) | Pass |
| iNod SUD | Needle Lock Override Force | Pass |
| iNod SUD | ISO 80369 Small-bore connectors for liquid and gases in healthcare applications | Pass |
| iNod SUD | ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices - Requirements and test methods | Pass |
| iNod SUD | Catheter Drive Cable Length | Pass |
| iNod SUD | Device Bronchoscopic Visibility | Pass |
| iNod SUD | Device Radiopacity | Pass |
| iNod SUD | Needle Indicator | Pass |
| iNod SUD | Needle Lock Engage/Disengage Force | Pass |
| iNod SUD | Handle Grip Area | Pass |
| iNod SUD | Actuation Mechanism Location | Pass |
| iNod SUD | Needle Locking Mechanism Location | Pass |
| iNod SUD | Handle Rotation | Pass |
| iNod SUD | Product can be held with scope | Pass |
| iNod SUD | Catheter Outer Diameter | Pass |
| iNod SUD | Imaging System Compatibility | Pass |
| iNod SUD | Motor Drive Compatibility - Torque | Pass |
| iNod SUD | Motor Drive Compatibility – Load | Pass |
| iNod SUD | Needle Exit Location | Pass |
| iNod Console | Archive Case Studies | Pass |
| iNod Console | Create Case Study | Pass |
| iNod Console | Annotate | Pass |
| iNod Console | Patient Display | Pass |
| iNod Console | Add Snapshots | Pass |
| iNod Console | Select and Review Case Studies | Pass |
| iNod Console | Export Event Logs | Pass |
| iNod Console | Export Recordings and Screenshots | Pass |
| iNod Console | Import/Export Case studies | Pass |
| iNod Console | Patient List Query | Pass |
| iNod Console | Select Patient | Pass |
| iNod Console | Mobile Configuration | Pass |
| iNod Console | Record Management | Pass |
| iNod Console | Default Modality | Pass |
| iNod Console | Power-On Self Test Status | Pass |
| iNod Console | Operating System | Pass |
| iNod Console | Power Up Duration | Pass |
| iNod Console | DICOM Archiving Performance | Pass |
| iNod Console | Expected Service Life | Pass |
| iNod Console | System Access to health delivery organization network | Pass |
| iNod Console | User Control | Pass |
| iNod Console | System Displays | Pass |
| iNod Console | Image Artifact Removal | Pass |
| iNod Console | Start Recording | Pass |
| iNod Console | Stop Recording | Pass |
| iNod Console | Linear Measurement on Ultrasound Frame | Pass |
| iNod Console | Imaging Depth | Pass |
| iNod Console | Distance Accuracy on Ultrasound Frame | Pass |
| iNod Console | Image Frame Rate: Ultrasound catheters | Pass |
| iNod Console | Gap detection | Pass |
| iNod Console | Catheter compatibility and Bandwidth | Pass |
| iNod Console | SUD Retention Force | Pass |
| iNod MDU | Receive Path Spectral Response | Pass |
| iNod MDU | Bi-Polar Tx - P-P Output Voltage Amplitude | Pass |
| iNod MDU | Pulse Uniformity – Bi-Polar Pulses | Pass |
| iNod MDU | Bi-Polar Output Bandwidth | Pass |
| iNod MDU | Receive Path Common Mode Gain | Pass |
| iNod MDU | RF Receive Path Noise Figure | Pass |
| iNod MDU | Receive Path Spurious Noise | Pass |
| iNod MDU | Pull Force and Side Force | Pass |
| iNod MDU | Rotational Speed | Pass |
2. Sample size used for the test set and the data provenance
The provided document describes non-clinical (bench) testing and software tests. It does not mention a "test set" in the context of clinical data or patient images for evaluating algorithm performance. The testing involved various units of the iNod SUD, Console, and MDU, as well as their components, but not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The testing described is bench testing and software verification, not clinical studies involving expert interpretation of medical images.
4. Adjudication method for the test set
Not applicable. The testing described is bench testing and software verification, not clinical studies requiring adjudication of expert interpretations.
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 MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in the document. The device is an ultrasound guidance system and needle, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. The device, the iNod Ultrasound Guidance System, is a medical instrument (hardware and software for imaging and biopsy). The "Product Specifications" for the various components (iNod SUD, iNod Console, iNod MDU) indicate tests performed on the physical and functional aspects of the device itself (e.g., Device Passability, Needle Extension Length, Imaging Depth, DICOM Archiving Performance, Rotational Speed). These are standalone tests of the device's inherent capabilities, not an algorithm's performance.
7. The type of ground truth used
For the physical and functional performance of the device (iNod SUD, Console, MDU), the "ground truth" would be the engineering specifications and established test methodologies (e.g., ISO standards, internal design requirements) that define the acceptable range or value for each "Product Specification." The tests determine if the device meets these pre-defined engineering and performance criteria.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device that requires a training set.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.