(25 days)
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
The Mazor X hosts guidance for spine and brain procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants (in spinal surgery). The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intraoperative planning based on Mazor X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The Mazor X enables accurate deployment of surgical accessories in the precise anatomical location according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT.
This document is a 510(k) premarket notification for the Mazor X device, which is a stereotaxic instrument for spinal and brain surgery. The document is primarily focused on demonstrating substantial equivalence to previously cleared devices rather than providing detailed study results against specific acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria and study details demonstrating compliance is not present in this document.
Here's a breakdown of the available information and what is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided document. The 510(k) focuses on demonstrating substantial equivalence to predicate devices, not on meeting predefined performance acceptance criteria with specific metrics.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly stated in the provided document. The document mentions "Performance Testing" but states that "No additional performance tests were required for the modified Mazor X system" because the modifications do not adversely affect safety, effectiveness, and performance. This implies that the current submission relies on the existing evidence for the unmodified Mazor X system and predicate devices, but the details of those studies are not included here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not explicitly stated in the provided document.
4. Adjudication Method for the Test Set
This information is not explicitly stated in the provided document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not explicitly stated in the provided document. The device is a surgical guidance system, not an AI-based diagnostic tool for "human readers." Therefore, an MRMC study in this context is unlikely to be relevant in the way it's described for diagnostic AI. The document describes the Mazor X as enabling precise positioning of instruments and providing 3D imaging capabilities, implying a direct guidance role for the surgeon, rather than an assistive role for human "readers."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not explicitly stated in the provided document. However, the device description emphasizes its role in "guidance" and enabling the surgeon to "precisely position surgical instruments." This suggests it's inherently a human-in-the-loop system, making a standalone algorithm-only performance study less directly applicable to its intended use in the absence of more detailed information.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This information is not explicitly stated in the provided document. Given its function as a surgical guidance system, ground truth would likely relate to the accuracy of instrument placement or implant positioning, potentially verified through intraoperative or post-operative imaging, or by clinical outcomes, but no details are provided here.
8. The Sample Size for the Training Set
This information is not explicitly stated in the provided document. Given the nature of a surgical guidance system, the "training set" might refer to data used for developing the planning algorithms or image processing, but no specifics are provided.
9. How the Ground Truth for the Training Set Was Established
This information is not explicitly stated in the provided document.
In summary, the provided 510(k) document for the Mazor X focuses on demonstrating substantial equivalence to predicate devices based on design, materials, mechanism of action, and intended use, rather than presenting detailed performance study results against specific acceptance criteria. Therefore, specific details about acceptance criteria, test set sizes, expert involvement, ground truth establishment, and comparative effectiveness studies are not included in this particular document.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).