(14 days)
The SURGIVISIO medical device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized.
The SURGIVISIO Device is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures. The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls. The mobile C-Arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal end of the 'C'. The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling. The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.
The provided text describes the SURGIVISIO Device, which is a mobile interventional fluoroscopic x-ray system, and states that it relies on the substantial equivalence to a previously cleared predicate device (SURGIVISIO system K202547). The primary change in the current submission is a software version update from 1.5.1 to 1.8.1.
While the document mentions "Software Verification testing verifying the software requirements perform as intended," it does not explicitly state specific acceptance criteria or provide a detailed study report that proves the device meets particular acceptance criteria beyond the software verification. The core of the argument for acceptance is substantial equivalence to the predicate device, implying that since the software update maintains the same intended use and performance, it meets the inherent criteria of the predicate.
Given this, I will infer the implied acceptance criteria from the claim of substantial equivalence and the listed comparison of technological characteristics.
1. A table of acceptance criteria and the reported device performance
Since specific numerical acceptance criteria for performance are not explicitly stated for this 510(k), and the device essentially claims "same as predicate" for performance, the acceptance criteria are implicitly that the software update does not degrade the performance characteristics of the predicate device.
| Acceptance Criteria (Implied from Substantial Equivalence to K202547) | Reported Device Performance (SURGIVISIO Device) |
|---|---|
| Functional Equivalence: | |
| - Same Intended Use/Indication for Use | The SURGIVISIO medical device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized. (Same as predicate) |
| - Same Principle of Operation | Similar principle of operation as the predicate device. (Stated in Section 7: Substantial equivalence) |
| - Similar Technical Characteristics | All technical characteristics (e.g., Mechanical configuration, Movement range, kV Range, mA Range, Pulse frequency, Detector technology, Image Matrix, X-ray tube technology, 2D Imaging, 3D Imaging characteristics, Monitor cart/Workstation, Screen displays, Image output format, LAN network connection, Computer Aided Surgery (CAS) interface) are identical to the predicate device. |
| Safety and Effectiveness: | |
| - Biocompatibility maintained | Same as the predicate. |
| - Electrical Safety Testing maintained | Same as the predicate. |
| - Performance Testing maintained | Same as the predicate. |
| - Software functionality as intended | SURGIVISIO software was verified and validated according to IEC 62304 Medical Device Software. Results of these validations and verifications confirm that the SURGIVISIO software complies with its specifications. |
| - Clinical images unchanged | Same as predicated. |
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 states, "No clinical tests were conducted to demonstrate substantial equivalence." Therefore, there is no test set of patient data mentioned for evaluating performance in the context of this software update. The verification focused on software requirements and compliance with IEC 62304.
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)
Since no clinical tests using patient data were conducted, no experts were used to establish ground truth for a test set. The validation was against software specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical test set requiring adjudication was used.
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, as no clinical tests or human reading evaluations are mentioned for this software update. The device itself is an imaging system with an integrated Computer Aided Surgery (CAS) feature, but the submission doesn't detail performance studies of this CAS feature, instead focusing on the equivalence of the overall system after a software update.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Software Verification testing verifying the software requirements perform as intended" and "Results of these validations and verifications confirm that the SURGIVISIO software complies with its specifications" indicate that standalone software testing was performed against specified requirements. However, the specifics of what those requirements are (e.g., accuracy, precision of specific measurements or detections if any) are not detailed. It's a general statement of software verification and validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the software verification and validation, the ground truth would be the software specifications and requirements themselves. The software was tested to ensure it met its predefined functional and non-functional requirements.
8. The sample size for the training set
Not applicable/Not provided. This submission is for a software update to an existing imaging system, claiming substantial equivalence based on verification and validation against specifications, not a new AI algorithm that would typically involve a distinct training set. The device description does not imply a machine learning component requiring a training set in the conventional sense for this submission.
9. How the ground truth for the training set was established
Not applicable as no training set is mentioned in the context of this submission.
§ 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.