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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.

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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:

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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.

Ask a specific question about this device

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.

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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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