(14 days)
The SURGIVISIO 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 structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such 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 SPX1 Instruments are a set of dedicated accessories intended to be used in conjunction with the SURGIVISIO Device in order to enable stereotaxic guidance. More specifically, and when used with the 3D imaging, they support the registration of patient anatomy with the 3D reconstructed image. the Submissions K202547/ K220627 consider SPX1 instruments set with the standard 3D Imaging Set SPX1 accessory.
This submission aims at clearing a new imaging set accessory possibility: the 3D Offset Imaging Set SPX1 accessory, containing same patient reference and wedges as 3D imaging Set SPX1 accessory already 510(k) cleared, and an offset phantom (new instrument). The principle of use of the Offset Phantom SPX1 is identical to the already 510(k) cleared Phantom SPX1 (belonging to 3D Imaging set). However, the Offset Phantom SPX1 additional value is to offset the imaging area that will be navigated during surgery by 10 cm from the standard configuration. The 3D Imaging Set SPX1 accessory will be considered as the predicate for the 3D Offset Imaging Set SPX1 accessory.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is primarily a 510(k) summary for a medical device (SURGIVISIO Device) and focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and the comprehensive study results that prove the device meets those criteria.
Here's why I cannot extract the requested information:
- Lack of Specific Acceptance Criteria: The text avers to "standards, acceptance criteria and results" in the "Performance Data" section but explicitly states that those details can be found in a "Design Control Activities Summary," which is not included in the provided document. Therefore, the specific numerical or qualitative acceptance criteria for the device's performance are missing.
- Focus on Substantial Equivalence, Not De Novo Performance Study: The document's core purpose is to show that a new accessory (3D Offset Imaging Set SPX1) for an existing device (SURGIVISIO Device) is substantially equivalent to a previously cleared version. It states, "No clinical tests were conducted to demonstrate substantial equivalence." The non-clinical tests mentioned are primarily design verification, accuracy verification, software verification, and packaging validation, all aimed at confirming the new accessory functions similarly and safely to the predicate, not necessarily to establish de novo performance against a set of independent acceptance criteria for the entire system from scratch.
- Missing Study Details: While some non-clinical tests are listed (design verification, accuracy verification, software verification, packaging validation), the text does not provide the methodology, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or direct performance metrics in the way you've requested for a detailed study. It merely states that these tests "have been performed as intended" or "have been conducted as intended."
In summary, the provided FDA document is a regulatory submission for substantial equivalence, not a detailed scientific study report containing the specifics of acceptance criteria and the comprehensive data proving the device meets them. The crucial information you've asked for (e.g., actual performance values against acceptance criteria, detailed methodologies, sample sizes for test sets, ground truth establishment details, MRMC study results) is explicitly stated to be elsewhere ("Design Control Activities Summary") or is simply not part of this type of regulatory summary.
§ 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.