(174 days)
nView system 1 is intended to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The device is indicated to image human anatomy up to 30 cm thickness.
The device is not indicated for mammographic or lung nodule applications.
The nView system 1 mobile fluoroscopic system is cone beam computed tomography X-ray system and a fluoroscopic X-ray imaging system consisting of two mobile units: a mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube, a high voltage generator, X-ray controls, and a mechanical "C" shaped structure which supports the X-ray tube and generator and the image receptor flat panel detector.
The monitor cart is a mobile platform that connects to the mobile C-arm by USB and HDMI cables, and which integrates the flat panel display monitors and user controls.
The nView system 1 employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the user, at the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device provides both real-time image capture visualization suitable for use both during surgery or immediately pre or post-surgery.
The device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses the images of a scan captured with relation to a predefined scan reference frame to compute the three-dimensional representation of the imaged object. The images are displayed on the screen of the monitor cart. It is possible to display projection views as well as orthogonal tomographic views.
Here's a breakdown of the acceptance criteria and study information for the nView system 1, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of acceptance criteria with specific numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device (Ziehm Vision RFD 3D, K142740) and compliance with various standards and guidance documents. The primary acceptance criteria appear to be:
- Substantial Equivalence: The device's intended use and technological characteristics are substantially equivalent to the predicate.
- Safety and Effectiveness: The device is safe and effective for its intended users, uses, and use environments.
- Compliance with Standards: The device complies with mandatory and voluntary standards (e.g., 21 CFR 1020.30, ES60601-1, IEC 60601 series, ISO 14971).
- Clinically Acceptable Performance: Performance is clinically acceptable as determined by a qualified expert evaluation.
Based on the provided text, a table can be constructed to show how the nView system 1 aligns with the predicate, rather than explicit numerical acceptance criteria for performance metrics.
| Feature/Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported nView System 1 Performance |
|---|---|---|
| Intended Use | Similar to predicate: 2D and 3D imaging for adult and pediatric populations (all ages), fluoroscopic and tomographic imaging for various surgical procedures, visualization of complex anatomical structures, bones, joints, spine regions, and joint fractures, up to 30 cm thickness. | Subset of Predicate: 2D and 3D imaging of adult and pediatric populations over 6 years of age. Fluoroscopic and tomographic imaging during orthopedic surgical procedures for 3D visualization of complex anatomical structures (high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities). Indicated to image human anatomy up to 30 cm thickness. Not indicated for mammographic or lung nodule applications. |
| Safety | Device is safe for intended users, uses, and environments (demonstrated via risk analysis, V&V, compliance with safety standards). | Risk analysis completed, risk control implemented. Testing results support all requirements met acceptance criteria. Subject device found safe for intended users, uses and use environments through design control V&V process. |
| Effectiveness | Device is effective for intended users, uses, and environments (demonstrated via clinical acceptability, V&V, compliance with performance standards). | Testing results support all requirements met acceptance criteria. Subject device found effective for intended users, uses and use environments through design control V&V process. Clinically acceptable performance per qualified expert evaluation. |
| Image Quality | Equivalent to predicate (Ziehm Vision RFD 3D) for the indicated uses, specifically for high-contrast bony anatomy. | Uses a CMOS Digital Detector (30 cm x 30 cm) with 1952 x 1952 resolution (used in binned mode to be equivalent to predicate resolution). Produces 2D and 3D image datasets. Claimed "clinically acceptable performance." |
| Radiation Dose | Acceptable radiation dose for diagnostic imaging. | Designed to operate at a lower radiation dose than the predicate. Shorter acquisition time (2 or 4 seconds vs. 48 seconds for predicate) reduces radiation and motion artifacts. |
| Technical Attributes | Similar technical characteristics to predicate (e.g., mobile C-arm, X-ray imaging, 3D reconstruction, user interface). | Mobile Fluoroscopic C-Arm, 2D and 3D imaging using X-rays, iterative algorithm for 3D reconstruction. Touch control interface. Utilizes a Multi Arc Source Trajectory for reconstruction geometry. Limited angle reconstruction (117-degree multi-arc scan). CMOS Digital Detector. |
Study Information
The document describes non-clinical testing for substantial equivalence, rather than a specific clinical study with detailed performance metrics.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a sample size for a test set or the data provenance (country of origin, retrospective/prospective). It mentions "non-clinical tests were conducted on the subject device during product development" and "Additional engineering bench testing was performed including the clinical and non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation." This implies a series of technical and engineering tests rather than a clinical trial with a specific patient dataset. -
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):
The document states: "It has been demonstrated that the subject device has clinically acceptable performance per a qualified expert evaluation."- Number of experts: Not specified.
- Qualifications: "Qualified expert" is mentioned, but specific qualifications (e.g., specialization, years of experience) are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for establishing ground truth or evaluating the device's performance in the described "qualified expert evaluation." -
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:
The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The nView system 1 is described as an imaging device, and the AI component (iterative reconstruction algorithm) is integral to its image generation, not an assistive AI layer for human interpretation itself. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document describes the performance of the "nView system 1," which includes the entire device (C-arm, software, imaging capabilities). The "iterative algorithm" is an intrinsic part of how the device generates its 3D images. Therefore, the standalone performance of the algorithm is the device's imaging performance, as the algorithm is embedded within the device for image reconstruction. The discussion around "clinically acceptable performance" refers to the output of this integrated system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document states "clinically acceptable performance per a qualified expert evaluation." This suggests that the "ground truth" for evaluating the clinical acceptability of the images produced by the device was based on expert assessment/consensus of the image quality and diagnostic utility for the stated indications. It does not mention pathology or outcomes data as primary ground truth for the device's imaging output. -
The sample size for the training set:
The document does not specify a training set sample size. While the device uses an "iterative algorithm" for 3D reconstruction, this typically refers to a mathematical process, not necessarily a machine learning algorithm that requires a "training set" in the conventional sense of supervised learning on a large dataset of patient images. If machine learning was involved, the details are not provided. -
How the ground truth for the training set was established:
As no explicit training set or machine learning model is detailed in the submission, the document does not describe how ground truth for a training set was established. The iterative reconstruction algorithm is a computational method for image formation, less dependent on a "ground truth" derived from expert annotations of a training set compared to, say, a CADe or CADx algorithm.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.