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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 a 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) K230064.

This 510(k) clearance letter describes a device, the Mazor X System / Mazor X Stealth Edition, and its substantial equivalence to a predicate device. It includes detailed information about new AI-enabled features: "2D Automatic Measurements" and "Plan Assist." The following analysis focuses on the acceptance criteria and study details for these AI components as presented in the provided text.

Acceptance Criteria and Reported Device Performance

Device: Mazor X System / Mazor X Stealth Edition (Software enhancements for 2D Automatic Measurements and Plan Assist)

Detailed Study Information for AI-enabled Features

1. 2D Automatic Measurements (AI-enabled Feature)

• Sample Size for Test Set:
  • Clinical Evaluation: 146 AP images, 253 LAT images (for all spinopelvic parameters). Each specific spinopelvic parameter had its own sample size ranging from 24 to 126 images.
• Data Provenance for Test Set: Not explicitly stated (e.g., country of origin). The note about "U.S. certified spine surgeons and radiologists" for reference standard implies some U.S. involvement, but doesn't specify data origin. It is explicitly stated that these datasets were independent from the development dataset, with data source site-level separation to ensure data independence.
• Number of Experts for Ground Truth (Test Set): Three U.S. board-certified radiologists.
• Qualifications of Experts (Test Set): U.S. board-certified radiologists. (No years of experience provided).
• Adjudication Method (Test Set): Not explicitly stated, but implies individual evaluation by the three radiologists and comparison to AI measurements.
• MRMC Comparative Effectiveness Study: No, a standalone performance of the AI algorithm was evaluated against expert annotations.
• Standalone Performance: Yes, the accuracy of the endplate and femoral heads detection algorithms, and the accuracy of 13 spinopelvic parameters' measurements were evaluated.
• Type of Ground Truth (Test Set): Expert annotations/measurements. Each spinopelvic parameter's ground truth was comprised of annotations (endplate lines, endplate endpoints, and/or femoral head circles) performed by the three U.S. board-certified radiologists using the Mazor X device.
• Sample Size for Training Set:
  • Endplate Detection: 2327 AP images, 2651 LAT images.
  • Femoral Heads Detection: 2233 LAT images.
• How Ground Truth for Training Set was Established: Endplate line and Circle femoral heads annotations were performed by trained labelers within a quality-controlled environment. In case of multiple annotations, they were aggregated. More than 65% of the data was reviewed by U.S. certified spine surgeons and radiologists.

2. Plan Assist (AI-enabled Feature)

• Sample Size for Test Set: 326 screw plans from 25 spine images.
• Data Provenance for Test Set: Not explicitly stated (e.g., country of origin). It is explicitly stated that these datasets were separated at the site level from the development dataset to ensure data independence.
• Number of Experts for Ground Truth (Test Set): Three experts.
• Qualifications of Experts (Test Set): Not explicitly stated, but are referred to as "experts" who evaluated clinical acceptability.
• Adjudication Method (Test Set): Each AI-generated screw plan was evaluated by three experts for clinical acceptability.
• MRMC Comparative Effectiveness Study: No, a standalone performance of the AI algorithm was evaluated against expert judgment of clinical acceptability.
• Standalone Performance: Yes, the clinical acceptability of AI-generated screw positions was evaluated.
• Type of Ground Truth (Test Set): Expert judgment of clinical acceptability.
• Sample Size for Training Set: 160 studies (101 3D CT scans, 59 3D O-arm scans), 942 vertebrae, 5,795 unique screw placements, and over 23,000 screw plannings.
• How Ground Truth for Training Set was Established: Annotations for pedicle screw planning (referred to as "reference Screw planning") were manually performed by 34 qualified Surgical support technicians using a released Mazor X software.

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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 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.

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The Mazor X is indicated for precise positioning of surgical 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 prom 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 modified Mazor X hosts guidance for spine procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. 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 Mazor X System cleared in 510(k) K182077.

This document is a 510(k) premarket notification for a medical device (Mazor X) and, as such, does not contain the detailed acceptance criteria and study data explicitly requested for the device's performance. The FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or detailed performance metrics against specific acceptance criteria.

However, based on the provided text, I can infer some aspects related to "acceptance criteria" through the lens of a 510(k) submission, mainly focusing on software and hardware validation, and the comparison to a predicate device for safety and effectiveness.

Here's a breakdown of the information that can be extracted or inferred, addressing your points where possible:

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

The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" in this context are interpreted as the successful completion and verification of specified tests confirming the device's design requirements, safety, and functionality, particularly concerning software and hardware changes.

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

The document does not specify a "sample size" in terms of number of patients, cases, or images for a test set. The validation described refers to software testing and hardware verification.

• Sample Size: Not specified for performance testing. The "test cases" for software validation are mentioned but their number is not provided.
• Data Provenance: Not applicable in the context of this 510(k) as it describes engineering verification and validation rather than clinical study data. There's no mention of country of origin or retrospective/prospective study for performance data.

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

This information is not provided in the document. The "ground truth" for software and hardware validation is typically defined by engineering specifications and design requirements, rather than expert clinical review.

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

Not applicable/not provided. Adjudication methods are typically used in clinical studies involving human readers, which is not the focus of the performance tests described here.

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 MRMC comparative effectiveness study is mentioned. The submission is for a device modification (software and minor hardware changes) to an existing cleared device, Mazor X System (K182077). The focus is on demonstrating that the modifications do not adversely affect safety and effectiveness and that the new device is substantially equivalent to the predicate. The device's capabilities include "precise positioning of surgical instruments or spinal implants" and "navigation tracks the position of instruments," but there are no details on improved human reader performance with or without AI assistance.

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

The document describes the device's functions (3D imaging from 2D fluoroscopic projections, instrument tracking, surgical planning). The software validation tests mentioned ("design requirements," "procedure simplicity," "performance and robustness," etc.) imply standalone algorithm performance was evaluated against its design specifications without explicit human-in-the-loop performance details in this document. However, the device itself is an assistance system for surgeons, so it inherently has a human-in-the-loop component for its intended use. The performance tests mentioned focus on the device's ability to meet its functional requirements.

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

The "ground truth" for the performance tests described here would be the design specifications and requirements of the software and hardware. For example, for "software validation testing," the ground truth is conformance to the established design requirements. For "hardware changes verification," the ground truth is meeting the technical requirements, presumably against engineering benchmarks or validated measurements. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for these specific performance tests within this 510(k) summary.

8. The sample size for the training set

Not applicable. The document describes software validation and hardware verification of modifications to an existing device, not the development or training of a de novo AI algorithm using a separate training set.

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

Not applicable, as no training set is discussed in this regulatory document.

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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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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 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. The Mazor X is a device modification of the original Mazor X System cleared in 510(k) K163221.

The provided text describes a 510(k) premarket notification for the "Mazor X" device. This submission is for a modification of an existing device (Mazor X System, K163221), and therefore, the performance testing focuses on demonstrating that the modifications do not adversely affect the device's safety, effectiveness, and performance compared to the predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Limited Information on Acceptance Criteria and Studies:

It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence of a modified device to a predicate device. As such, it does not detail a comprehensive study establishing novel acceptance criteria or a full clinical study with specific performance metrics (like sensitivity, specificity, accuracy) that would be typical for a new device's initial clearance or a comparative effectiveness study. The "acceptance criteria" here are primarily about demonstrating that the modified device performs as well as the predicate and meets its design requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification submission, the "acceptance criteria" are implicitly tied to maintaining the performance and safety established by the predicate device and meeting design requirements for the modifications. Specific quantitative performance metrics are not provided in this document in a tabular format.

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

The document does not explicitly state sample sizes for tests. The descriptions focus on "validation testing" and "retesting" of specific modules and algorithms. It does not mention clinical studies with human patient data or specific "test sets" in the context of typical AI/machine learning evaluation (e.g., a set of patient images for diagnostic accuracy).

• Sample Size: Not specified.
• Data Provenance: Not specified. The tests are described as software validation testing and functionality testing for the modified Align module. This implies testing with internal data or synthetic data relevant to the software functionalities, rather than patient data from specific countries or retrospective/prospective studies.

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

Given the nature of the tests described (software and functionality validation), there's no indication that a "ground truth" was established by medical experts for a diagnostic or interventional task, which would typically involve human reviewers. The tests are against design requirements and algorithmic performance.

• Number of Experts: Not mentioned.
• Qualifications: Not mentioned.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the described tests are technical validations against specifications and functionality rather than human-interpreted diagnostic outcomes.

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

No MRMC study is mentioned. The document focuses on demonstrating that the modified device is as safe and effective as the predicate device, not on comparing human performance with and without AI assistance.

• Effect Size of Human Readers Improve: Not applicable; no MRMC study reported.

6. Standalone (Algorithm Only) Performance Study

The performance tests mentioned are for the integrated "Mazor X system" and its "software version" and "Align module." While these are tests of the algorithm's functionality, the document describes the system as enabling surgeons to position instruments and implants, and its imaging capabilities provide processing and conversion of fluoroscopic projections. This suggests the algorithm's performance is tested within the context of its intended function as part of a surgical guidance system, rather than as a standalone diagnostic tool. The "algorithm only" performance is embedded within the "Software validation testing" and "retraining" of the Align module.

7. Type of Ground Truth Used

The "ground truth" for the reported tests appears to be based on:

• Design requirements/specifications: For the software validation.
• Established functionality of the original Mazor X Align module: For retesting the modified Align module.
• Algorithmically derived correct states: For parameters like lateral positioning validation and vertebral end-plates recognition.

It is not based on expert consensus, pathology, or outcomes data as these are not clinical studies.

8. Sample Size for the Training Set

No information about a training set is provided. This 510(k) pertains to a device modification and validation, not the initial development or training of a machine learning model from scratch where a distinct "training set" would typically be detailed. The "software optimization" and "enhanced functionalities" likely involved development and testing, but the specific "training set" for any underlying machine learning components is not discussed.

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

Not applicable, as no training set is described in this document.

Ask a specific question about this device

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.

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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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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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The Renaissance X System is indicated for precise positioning of surgical instruments or implants during general spinal 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 Renaissance X System hosts guidance for spine procedures and intraoperative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. 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. With the imaging capabilities of the system the user can also visualize the implants on the patients CT.

The provided text describes a 510(k) premarket notification for the Mazor Robotics Ltd.'s Renaissance System, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of AI performance metrics like sensitivity, specificity, or AUC.

The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general performance testing (software validation, accuracy/repeatability, rigidity, collision avoidance). These are device-level safety and functional tests, not typically clinical performance studies that establish detailed acceptance criteria for diagnostic or AI-driven performance.

Here's a breakdown of what can be extracted or inferred from the document and what's explicitly missing:

Missing Information (and why it's missing from this document):

• A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy). The "Accuracy and Repeatability Testing" mentioned would likely have internal, engineering-level acceptance criteria (e.g., +/- X mm deviation), but these are not disclosed.
• Sample sized used for the test set and the data provenance: Not mentioned, as no specific clinical performance study for an AI component is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method: Not mentioned.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The focus is on the device's functionality, not how it improves human reader performance with AI assistance.
• Standalone (i.e. algorithm only without human-in-the loop performance) study: Not mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

What can be inferred/extracted from the document regarding "performance testing" (though not directly "acceptance criteria" in the AI sense):

The document lists "Performance Testing" undertaken, which includes:

• Software validation testing: "demonstrate that the modified software version meets its design requirements."
• Accuracy and Repeatability Testing: "demonstrate that the Renaissance X System has maintained the required accuracy, as specified in the device design requirement. These tests have established that the system is accurate every time as an integrated system, including the full assembly as will be performed in the Operating Room, and that it is able to repeatedly perform in the same standard when required." (No specific metrics or acceptance values are given).
• Rigidity Testing: "These tests demonstrate the mechanical integrity of the Renaissance X System. It shows that the system's design meets the functional requirements with safety margins."
• Collision Avoidance Testing: "these tests validates the system's ability to avoid collisions in the operating field, both with the patient and various objects used during the operation."

Summary of what's provided vs. requested:

The provided document details the regulatory clearance (510(k)) of the Renaissance System, emphasizing its substantial equivalence to a predicate device and its overall safety and functional performance tests. It states that "dence 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." However, it does not delineate specific (AI-related) acceptance criteria or detailed study results for its imaging or surgical guidance capabilities in the way a clinical trial or AI validation study would. The performance tests listed are general engineering and software validation tests, not clinical performance metrics against a defined ground truth.

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