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The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative guidance and tool trajectory / position confirmation.

The VUZE System (the "System") enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device quidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7.

The System offers pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative quidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intraoperative 2D images onto a patient's pre-operative 3D images.

The main system components include:

• Workstation running the VUZE Planning and Procedure software (pre-installed)
• Housing for the workstation, with a front door for user access as well as a back service door
• 32" touchscreen
• Isolation transformer
• Internal video acquisition device (frame grabber)
• Wheeled cart on which the above-listed items are placed.

The VUZE System is a medical imaging system intended to enable users to load pre-operative 3D images and planning data, and then register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. This supports device guidance during interventional spinal procedures, including pre-operative surgical planning and intra-operative guidance/tool trajectory confirmation.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of numerical acceptance criteria for specific performance metrics (e.g., accuracy values with defined thresholds). Instead, it states that the device successfully completed all evaluations and testing to demonstrate substantial equivalence and that technological differences do not raise new or different questions of safety and effectiveness.

The "Performance Data" section indicates:

• The VUZE System was verified and validated in accordance with 21 CFR 820.30.
• The device successfully completed all of the evaluations and testing shown below (referring to a list of tests).
• The results of testing provide assurance that the device is as safe and effective as the predicate.

Given this, the acceptance criteria are implicitly tied to the successful completion of the listed tests and adherence to recognized consensus standards, ensuring the device is "as safe and effective as the predicate." The reported performance is that the device met these implicit criteria by successfully completing all tests.

Implicit Acceptance Criteria and Reported Performance Summary:

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

The document does not specify a sample size for a test set in terms of patient cases or images.
It states: "No animal or human clinical data were needed to demonstrate substantial equivalency."
The testing appears to be primarily based on engineering verification and validation activities, including "Simulated Use / Quantitative Accuracy" and "Qualitative Image Output Validation," rather than a clinical test set with patient data. Therefore, details about data provenance (country of origin, retrospective/prospective) are not applicable or provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no human clinical data or explicit "test set" in a clinical sense with ground truth established by experts is mentioned, this information is not provided in the document. The validation relied on engineering and simulated testing.

4. Adjudication Method for the Test Set:

As no clinical test set requiring expert ground truth or adjudication is described, an adjudication method is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done.
• The document explicitly states: "No animal or human clinical data were needed to demonstrate substantial equivalency."
• Consequently, there is no effect size reported for human readers improving with or without AI assistance, as this type of study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device itself is a "Medical Image Management and Processing System" that provides "device guidance" and "tool trajectory/position confirmation" by displaying data for a human user (surgeon). It is not described as a standalone diagnostic or automated detection algorithm in the typical sense.
The listed tests include "Software Verification / Validation at the unit, integration and system levels" and "Simulated Use / Quantitative Accuracy," which would involve evaluating the algorithm's performance. The "Simulated Use" likely evaluates the system's performance as intended with a human-in-the-loop, even if using simulated data.
The prompt asks "algorithm only without human-in-the-loop performance". The information suggests that the system's function is to aid humans, so a purely "standalone" evaluation that completely excludes the human role might not be fully representative of its intended use. However, the software validation and quantitative accuracy testing would assess the algorithm's underlying technical performance. The document does not explicitly describe a "standalone" study in contrast to a human-in-the-loop study, but rather a comprehensive set of engineering tests for the full system.

7. The Type of Ground Truth Used:

For tests like "Simulated Use / Quantitative Accuracy" and "Qualitative Image Output Validation," the ground truth would likely be established through:

• Known simulated scenarios/phantoms: For "Simulated Use / Quantitative Accuracy," the "ground truth" would be the precisely known positions or trajectories in a simulated environment or phantom model, against which the system's output is measured.
• Pre-defined specifications/expected outputs: For "Qualitative Image Output Validation" and other verification steps, the ground truth would be the expected display properties, co-registration accuracy, or functional behavior as defined in the product requirements.
• Predicate device performance: Since substantial equivalence is claimed, the performance of the predicate device (Innova Vision Applications K092639) implicitly serves as a benchmark for safety and effectiveness.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as no human clinical data was used.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size. The VUZE System is described as using "3D imaging data of the patient's target anatomy and pre-operative surgical planning information registered against intraoperative 2D x-ray images." This suggests it's an image processing and guidance system rather than a machine learning model that requires a distinct "training set" in the context of deep learning, although underlying algorithms might have been developed using some data. However, for regulatory purposes, specific training set data is not provided.

9. How the Ground Truth for the Training Set Was Established:

Since no training set is described, information on how its ground truth was established is not provided.

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The Renaissance X System 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.

Renaissance 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 modified Renaissance X System 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 intra-operative planning based on Renaissance X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The modified Renaissance X System 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 modified Renaissance X System is a device modification of the original Renaissance X System cleared in 510(k) K140167 and the original Renaissance System with Brain Application cleared in 510(k) K120812.

The provided document is a 510(k) premarket notification for the Mazor Robotics Renaissance X System. Unfortunately, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant at the level of detail requested for a typical AI/ML device.

Instead, this document focuses on confirming that the modified system is substantially equivalent to previously cleared predicate devices. The performance testing section broadly states that "Software validation testing," "Stability Testing," and "Usability Testing" were performed, but it lacks the granular data required to fill in your requested table and study details.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, and expert involvement based on the provided text. The document confirms that the device meets its design requirements and maintains usability, but without specific metrics or comparative effectiveness data against the predicate.

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