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510(k) Data Aggregation
(233 days)
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: < 2.0 mm positional error • Trajectory angle accuracy: < 2.0 degrees immediately after automatic or paired point registration. (Identical to predicate device) |
| Clinical Accuracy | • 3D positional accuracy: ≤ 3.0 mm positional error • Trajectory angle accuracy: ≤ 3.0 degrees with patient reference for spine applications. (Equivalent to predicate device. The document notes: "The subject has the same accuracy numbers as the predicate. The subject and predicate have narrower claims of spine applications only. The accuracy numbers are adjusted from the reference device based on the reduced clinical applications.") |
| Software Level of Concern | "Moderate Level of Concern" (Implies adherence to specific software documentation guidelines) |
| Safety and Effectiveness | "The nView s1 with nav option has demonstrated 3D positional accuracy with a positional error < 2.0 mm and trajectory angle accuracy error < 2.0 degrees immediately after automatic or paired point registration. This performance was determined using a cadaveric specimen and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components." "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence." "No new questions of safety and effectiveness are raised in the subject device." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly mentions a cadaveric study for demonstrating registration accuracy:
- Sample Size: Not specified for the cadaveric study.
- Data Provenance: "cadaveric specimen" - implies a laboratory/research setting. Country of origin not specified. No indication of retrospective or prospective.
For other aspects like "Usability" or "Risk Analysis," typical testing would involve subjects/data, but no specific sample sizes or provenance information are provided in this summary.
3. 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 does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for establishing ground truth for the test set.
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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any human reader improvement with AI assistance. The device is a "Mobile Fluoroscopic C-Arm" with a "nav option" which suggests image-guided surgery, not a diagnostic AI interpretation tool. Therefore, an MRMC study in the context of diagnostic interpretation is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document states: "The nView s1 with nav option has demonstrated 3D positional accuracy with a positional error < 2.0 mm and trajectory angle accuracy error < 2.0 degrees immediately after automatic or paired point registration." This accuracy measurement, especially in a cadaveric study, would typically be a standalone (algorithm only) performance evaluation of the navigation system's ability to localize points in space and align image to physical coordinates, without direct human cognitive interpretation or decision-making as the primary output being measured.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the registration and clinical accuracy studies, the ground truth would likely be established through:
- Physical measurements/Metrology: In the cadaveric study for registration accuracy, physical measurements (e.g., using a high-precision measurement system) would be the ground truth against which the device's calculated positional and angular errors are compared. The reference to "paired point registration" and "divots in the bone" further supports a physically established ground truth.
- The document mentions "identifiable anatomical landmark or a fiducial on the skin" for the reference device, suggesting physical landmarks are used for ground truth in such navigation systems.
The document does not mention expert consensus, pathology, or outcomes data as ground truth.
8. The sample size for the training set
The document does not provide any information regarding the sample size of a training set. This submission is for a 510(k) of an updated version of a previously cleared device, not a de novo AI device requiring extensive training data disclosure in this summary. The "iterative algorithm" for 3D reconstruction is mentioned, but specific training data for this algorithm (if it utilized machine learning in the conventional sense) is not detailed.
9. How the ground truth for the training set was established
Since no training set information is provided, there is no information on how ground truth for any training set was established.
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