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The Mazor X is indicated for precise positioning of surgical 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 enables the surgeon to precisely position surgical instruments and/or implants (in spinal and brain surgery). The Mazor X enables guidance for spine and brain procedures and intra-operative 3D image processing capabilities. 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 intra-operative 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. The Mazor X is a device modification of the original Renaissance X System cleared in 510(k) K152041.

This document describes the Mazor X, a device for precise positioning of surgical implants during spinal and brain surgery, and its substantial equivalence to predicate devices. It focuses on the device's software validation and measurement comparison testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical quantitative sense for clinical metrics like accuracy, sensitivity, or specificity. Instead, it discusses performance testing related to software and measurement comparison.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified for the software validation or measurement comparison testing. The document states "software validation tests" and "measurement comparison testing" were performed, but no number of samples or cases is given.
• Data Provenance: Not specified. It's unclear if these tests involved patient data, simulated data, or a combination. The document mentions "pre-operation planning based on the patient's CT scan" and "intra-operative planning based on Mazor X 3D Scan image," suggesting potential use of imaging data, but the source (country, retrospective/prospective) for the testing itself is not detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The performance testing described (software validation, measurement comparison) doesn't inherently require expert-established ground truth in the same way a clinical diagnostic study would. The "ground truth" for software validation would be its functional specifications, and for measurement comparison, it would be the accepted calculations of the predicate device (Surgimap).

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described tests (software validation, measurement comparison), a multi-reader adjudication method would not typically apply.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case comparative effectiveness study is not mentioned in the document. The testing described focuses on standalone device performance (software and measurement capabilities) compared to a predicate device's calculations, rather than comparing human reader performance with and without AI assistance.

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

Yes, the described performance testing appears to be a standalone (algorithm only) assessment. The software validation tests demonstrate the modified software's adherence to design requirements, and the measurement comparison tests evaluate the X Align module's calculations against Surgimap's, implying an assessment of the algorithm's output rather than human interaction with it.

7. The Type of Ground Truth Used

• For software validation: The "ground truth" would be the design requirements and specifications of the software, as outlined in the FDA Guidance for Premarket Submissions for Software Contained in Medical Devices and the IEC 62304 standard.
• For measurement comparison: The "ground truth" for the X Align module's performance would be the measurement calculations derived from the predicate device, Surgimap.

8. The Sample Size for the Training Set

This information is not provided. The document details performance testing (validation and comparison) but does not discuss the development or training of any machine learning components, nor any associated training set sizes.

9. How the Ground Truth for the Training Set was Established

This information is not provided, as the document does not mention a training set or the establishment of its ground truth.

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