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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 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 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. Same as the predicate device the modified Mazor X consists of a workstation with dedicated software, the surgical system, navigation camera, accessories, instruments and disposable kits. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the Mazor X System cleared in 510(k) K203005.

The provided text is a 510(k) Summary for the Mazor X System (Mazor X Stealth Edition), detailing its substantial equivalence to a predicate device (K203005). The document focuses on comparing technological characteristics and asserting that modifications do not raise new safety or effectiveness concerns.

However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested by the prompt. This document is a regulatory submission demonstrating substantial equivalence, not a clinical study report with performance metrics like accuracy, sensitivity, or specificity against defined ground truth.

Therefore, many parts of your request for acceptance criteria and study details cannot be fulfilled from the provided text.

Here's what can be extracted and what is missing:

Device: Mazor X System (Mazor X Stealth Edition)

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance in terms of equivalence to a predicate device rather than specific acceptance criteria for a new study. The closest to "acceptance criteria" related to performance are the accuracy metrics established by the predicate device.

Note: The document explicitly states: "A series of performance bench testing demonstrated that the absolute robotic depth error is smaller than ±1.5 mm and that the overall system accuracy is equivalent to the predicate device system accuracy. In addition, the navigation accuracy was tested and found to be equivalent to the navigation accuracy performance of the predicate device (mean positional error <2mm and mean trajectory error of 2°)."

2. Sample Size and Data Provenance

• The document mentions "Bench testing" and "Non-Clinical Performance Data" but does not specify the sample size used for these tests (e.g., number of cadavers, phantoms, or clinical cases, if any).
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The testing described appears to be laboratory/bench testing, not clinical data from patients.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not stated. The ground truth for device accuracy (positional, trajectory, depth) would typically be established by highly precise measurement systems (e.g., optical tracking, CMM) during bench testing, not by human experts interpreting images for diagnostic purposes. The document doesn't describe any human expert review process for determining the accuracy metrics.

4. Adjudication Method for the Test Set

• Not applicable. As the ground truth is established via precise measurements in a bench test setting for accuracy, an adjudication method for human interpretation is not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No evidence of MRMC study. The document describes a robotic and navigation system's accuracy, not a diagnostic or assistive AI system that requires human reader improvement analysis.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly. The performance data (robotic and navigation accuracy) are presented as inherent capabilities of the device itself, derived from "bench testing." This would be the "standalone" performance of the robotic system's guidance capabilities.

7. Type of Ground Truth Used

• Based on the description of "bench testing" for "robotic depth mean accuracy," "system accuracy," and "navigation accuracy," the ground truth likely involves physical measurements using highly accurate instruments (e.g., CMM, optical trackers, etc.) on phantoms or test setups, calibrated against known standards. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Not applicable / Not stated. This document describes a robotic surgical system, not a machine learning or AI model in the sense of one that learns from a "training set" of patient data (e.g., images for diagnosis). The software modifications mentioned are "enhancements to enable extended functionality" and "UX/UI improvements," rather than the introduction of a new AI algorithm requiring a large training dataset with labelled ground truth. The system relies on its inherent mechatronic precision, optical tracking, and image processing capabilities rather than patterns learned from a data training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. See #8. No training set is described for an AI/ML model that would require such ground truth establishment.

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The Mazor X is indicated for precise positioning of spinal implants during general spinal and brain surgery. It may be used in 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 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 integrates a new Navigation feature, which enables tracking compatible spine instruments. The previously cleared Mazor X System enables mechanical positioning of a tool or instrument and determining its orientation and trajectory. The new Navigation feature tracks the position of compatible surgical instruments in or on the patient anatomy during surgery and continuously updates the instrument position on the image of the patient's anatomy. The modified Mazor X System can operate with or without the Navigation feature.

This document describes the FDA's clearance of the Mazor X System (Mazor X Stealth Edition) and the supporting performance testing. It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a new navigation feature.

Here's an analysis of the provided text in response to your request, identifying what information is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it globally states that the "overall accuracy under worst-case scenario navigation tool positioning calculated the position and trajectory errors" and that the "software changes did not affect the previously cleared robotic guidance trajectory accuracy (i.e. < 1.5mm)".

However, we can infer a key performance target related to accuracy:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document mentions "Cadaver validation activities (GC17021, TP-GC17021)", but the number of cadavers or specific test samples (e.g., number of anatomical targets or measurements) for the navigation accuracy testing is not specified.
• Data Provenance: The cadaver studies likely used ex-vivo data. The country of origin for this data is not specified. It's implied to be a pre-clinical, prospective evaluation based on the nature of the testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document details engineering and software validation tests rather than clinical evaluations involving human expert readers for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. The performance testing described is technical validation of system accuracy, not a study requiring adjudication of human reader interpretations.

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

There is no indication that an MRMC study was performed or that the device (Mazor X Stealth Edition) involves "AI assistance" in the sense of an algorithm interpreting images for human readers. The device is described as a robotic guidance and navigation system.

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

The primary performance test described is "navigation accuracy testing," which evaluates the system's ability to accurately track instruments and guide trajectories. This is essentially a "standalone" or "device-only" performance assessment in a controlled (cadaver) environment, measuring the inherent accuracy of the system. The "robotic guidance trajectory accuracy (i.e. < 1.5mm)" is a key standalone accuracy parameter.

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

For the navigation accuracy testing, the ground truth would likely be established through precise metrological methods (e.g., coordinate measuring systems, high-resolution imaging with known fiducial markers) that can independently verify the true position and trajectory, against which the device's measurements are compared. The document mentions "Overall accuracy under worst-case scenario navigation tool positioning calculated the position and trajectory errors," implying a quantitative comparison to a known true value, but the specific method of establishing this precise ground truth is not detailed. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

The document does not describe a training set in the context of a machine learning model, as the device is a robotic guidance system, not an AI diagnostic algorithm. Therefore, this information is not applicable/provided.

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

As there's no mention of a traditional machine learning training set, this information is not applicable/provided.

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