Search Results

The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures.

Mazor X 3D imaging capabilities provide a procession 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 navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

The Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the original Mazor X System cleared in 510(k) K200935.

The provided text is a 510(k) premarket notification for the Mazor X system, which outlines the device's indications for use and states that the current submission is for software and minor hardware modifications to a previously cleared device (K200935).

It does not contain a detailed study proving the device meets specific acceptance criteria in the typical sense of a clinical trial. Instead, it focuses on verifying that the modifications to the already cleared device do not adversely affect its safety, effectiveness, and performance. The performance testing described is primarily focused on software validation and ensuring that the modifications did not degrade previously established accuracy metrics.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, etc., are not applicable or not provided in the given document for the current submission. The document refers to these metrics as previously established for the predicate device.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available:

1. Table of acceptance criteria and reported device performance:

   Acceptance Criteria (from predicate validation)	Reported Device Performance (after modifications)
   Robotic guidance trajectory accuracy: < 1.5mm	The modifications did not affect previously cleared robotic guidance trajectory accuracy (< 1.5mm).
   System navigation accuracy: < 2.0mm, 2.0°	The modifications did not affect previously cleared system navigation accuracy (< 2.0mm, 2.0°).
   Software meets design requirements	Software validation tests demonstrate that the Mazor X software version meets the design requirements.
   Hardware meets requirements	Modified hardware was tested and verified to meet requirements, using identical protocols as the cleared device parts.

2. Sample size used for the test set and the data provenance:

   • Not applicable/not provided for the current submission's performance testing. The document states "The modified Mazor X System was also tested to ensure that the software changes did not affect the previously cleared robotic guidance trajectory accuracy...". This implies internal engineering verification rather than a clinical human-subject test set for this specific submission. Data provenance for the original accuracy metrics is not mentioned in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/not provided for the current submission. The performance testing described is an engineering verification against previously established accuracy metrics rather than a re-establishment of ground truth through expert review.

4. Adjudication method for the test set:

   • Not applicable/not provided.

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. This type of study is not described for this submission. The device is a robotic surgical assistance system, not an AI diagnostic tool primarily impacting human reader performance in image interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The "trajectory accuracy" and "navigation accuracy" mentioned are standalone performance metrics of the robotic system itself, without human input during the measurement, although the system is designed to be used with human operators. The document implies these were verified for the modified system: "The modified Mazor X System was also tested to ensure that the software changes did not affect the previously cleared robotic guidance trajectory accuracy... and system navigation accuracy..."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the accuracy metrics (1.5mm and 2.0mm/2.0°), the ground truth would typically be established through precise metrological measurements using fiducial markers or precise phantoms in a controlled environment. The document does not specify the exact type of ground truth or its establishment method for these metrics, only that they were previously "cleared."
   • For software validation, the ground truth is the design requirements and specifications themselves.

8. The sample size for the training set:

   • Not applicable/not provided. This document describes software and minor hardware modifications to an existing device, not the development or training of a new AI algorithm.

9. How the ground truth for the training set was established:

   • Not applicable/not provided, as no training set for an AI algorithm is mentioned.

Ask a specific question about this device