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510(k) Data Aggregation
(233 days)
nView medical
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations 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 nView s1 is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.
The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.
Navigation instrumentation consists of a navigated surgical probe and a patient reference.
The device contains software. The nav option tracks single-use sterile navigation instrumentation. It does not contain biologics, drugs, coatings, or additives.
The nView s1 with nav option 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 poth real-time image capture and post capture visualization suitable for use immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery.
The device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses 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 tomographic views. The navigation option utilizes optical camera technology to track the C-arm, the instruments, and the patient.
The provided text describes the nView s1 with nav option, a mobile fluoroscopic C-Arm imaging system with navigation capabilities. The 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device (nView s1 with nav option, K211064) and a reference device (Medtronic Navigation Inc - StealthStation™ S8 system, K162309).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating equivalence rather than explicitly listing acceptance criteria with detailed success/failure values for all performance characteristics. However, it does state specific performance criteria for Registration Accuracy and Clinical Accuracy.
| Acceptance Criteria (Stated Performance Goals) | Reported Device Performance (Subject Device) |
|---|---|
| Registration Accuracy | • 3D positional accuracy: |
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(203 days)
nView medical
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations 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 nView sl is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to aid in pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray 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 with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking markers. The tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.
The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.
Navigation instrumentation consists of a navigated surgical probe and a patient reference.
The nView s1 with nav option 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 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 immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery.
The provided text does not contain detailed information about a study proving the device meets specific acceptance criteria in a quantitative manner (e.g., sensitivity, specificity, or specific error rates with confidence intervals). Instead, it discusses the device's conformance to various medical device standards and guidance documents, as well as a comparison to predicate devices, to demonstrate substantial equivalence.
However, based on the text, we can infer some "acceptance criteria" related to performance characteristics and the device's adherence to standards. The document primarily focuses on demonstrating substantial equivalence to predicate devices.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since specific quantitative performance acceptance criteria (e.g., accuracy thresholds for diagnostic tasks) and corresponding reported performance metrics (e.g., measured sensitivity, specificity) are not explicitly stated in the provided document, I will infer the "acceptance criteria" from the comparison attributes to predicate devices and the clinical accuracy stated for the navigation option. The "reported device performance" will be the values specified for the proposed device itself.
| Acceptance Criteria (Inferred from Predicate Comparison & Device Claims) | Reported Device Performance (as stated for nView s1 with nav option) |
|---|---|
| Imaging System Performance | |
| 2D and 3D imaging capability for adult and pediatric populations over 6 years of age | Provides both 2D and 3D imaging of adult and pediatric populations over 6 years of age. |
| Fluoroscopic and tomographic imaging for orthopedic surgical procedures, high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of upper/lower extremities | 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. |
| Image human anatomy up to 30 cm thickness | Indicated to image human anatomy up to 30 cm thickness. |
| Not indicated for mammographic or lung nodule applications | Not indicated for mammographic or lung nodule applications. |
| Imaging acquisition time comparable to predicate (e.g., 2 or 4 seconds) | 2, 4, 8 seconds |
| Reconstruction Time | 1 to 30 seconds |
| 3D resolution | 0.721 x 0.721 x 0.721 mm (Improved compared to primary predicate's 1.00 x 1.00 x 1.00 mm) |
| Navigation System Performance (for pilot hole verification of 4.5 mm pedicle screws in thoracic and lumbar spine) | |
| Aid in pilot hole verification for pedicle screw placement of 4.5 mm screws in thoracic and lumbar spine regions | Intended as a navigation system to aid in pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. |
| Posterior approach open spinal procedures in pediatric populations over 6 years of age | Indicated for posterior approach open spinal procedures in pediatric populations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy. |
| 3D positional accuracy (for spine applications) | Positional error ≤ 3.0 mm |
| Trajectory angle accuracy (for spine applications) | Trajectory angle accuracy error ≤ 3.0 degrees |
| Adherence to relevant standards (e.g., electrical safety, EMC, radiation protection, risk management, usability) | Compliance with 21 CFR 1020.30, 32; ES60601-1; IEC 60601-1-2, -1-3, -1-6, -2-43, -2-54; ISO 14971; ISO 10993-1; ISO 17665-1; ASTM F2554-18, and FDA guidance documents. Risk analysis completed, risk controls implemented. Human factors usability validation performed. Cybersecurity requirements met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any clinical test or test set, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective nature) for performance evaluation. The "Summary of non-clinical test data" mentions "Non-clinical tests were conducted on the subject device during product development" and "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence." However, no numbers or details on the nature of these tests are provided.
3. Number of Experts Used to Establish Ground Truth & Qualifications
The document does not mention any details regarding experts used to establish ground truth or their qualifications. The evaluation of the device appears to be based on engineering verification and validation, and comparison to predicate devices, rather than a clinical study requiring expert ground truth for specific diagnostic or interventional tasks.
4. Adjudication Method
No information is provided regarding an adjudication method. This is expected given the lack of specific details about a clinical study involving human readers or expert panels.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size of human readers improving with AI vs. without AI assistance. The device is a navigation and imaging system, not an AI-assisted diagnostic tool in the sense that would typically warrant such a study.
6. Standalone Performance Study (Algorithm Only)
The document does not explicitly describe a standalone algorithm-only performance study. The core function of the device is to generate images and provide navigation guidance based on those images for human use during surgery. The performance metrics (e.g., 3D positional accuracy) are related to the system's ability to accurately localize, which is part of its integrated design.
7. Type of Ground Truth Used
Based on the nature of the device (imaging and navigation system for surgical procedures) and the limited information provided, the ground truth for the stated accuracy claims (positional and angular accuracy) would typically be established through phantom studies or cadaveric models using known, precise measurements as ground truth, validated against physical markers or reference systems. However, the document does not explicitly state the type of ground truth used for these specific measurements, only that "non-clinical tests were conducted" and "Testing for verification and validation for the device was found acceptable."
8. Sample Size for the Training Set
The document does not specify a training set sample size. This is not applicable in the context of the information provided, as the submission focuses on hardware and integrated software for imaging and navigation, not a machine learning model that would typically require a training set.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning model, this information is not applicable and therefore not provided in the document.
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(174 days)
nView medical, Inc.
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.
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