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The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.

The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.

The Paradigm System is used with an external monitor.

The provided document is a 510(k) premarket notification acceptance letter from the FDA for the Paradigm System. It primarily discusses the device's substantial equivalence to a predicate device (also named Paradigm System) and lists relevant regulations and testing standards.

Crucially, this document does NOT contain details about the acceptance criteria and the specific study performance that proves the device meets those criteria. It mentions "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements," and lists some standards used for testing (e.g., IEC 60601-1, ISO 14971, ASTM F2554-22 for positional accuracy). However, it does not provide the actual quantitative acceptance criteria or the results from these studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. While ASTM F2554-22 (Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems) is mentioned, the specific acceptance thresholds and the measured positional accuracy of the Paradigm System are not detailed.
2. Sample size used for the test set and the data provenance: The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model" but does not specify the sample size (number of cadavers, number of anatomical sites, etc.) or the provenance of the cadavers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the study details are missing.
4. Adjudication method for the test set: Not applicable as the study details are missing.
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: The device is a stereotaxic image guidance system, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies with human readers. The document does not mention any AI components that would assist human readers in image interpretation. Its function is to guide surgical instruments, fusing real-time camera imaging with medical imagery (CT) and surgical navigation data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a system for surgical guidance, implying a human (surgeon) is always in the loop. It does not mention a standalone algorithm evaluation.
7. The type of ground truth used: For positional accuracy, the ground truth would typically be established by highly accurate measurement systems (e.g., optical tracking systems, CMMs) in a controlled environment, not expert consensus or pathology in the traditional sense of diagnostic AI. The document mentions "Non-Clinical Design Validation conducted in Cadaveric Model," which suggests physical measurements against a known fiducial or planned trajectory.
8. The sample size for the training set: Not applicable, as detailed information on any AI/machine learning components or their training is not provided. The system uses "preoperative imaging segmentation" but doesn't elaborate on whether this involves deep learning requiring a dedicated training set.
9. How the ground truth for the training set was established: Not applicable, as information on training sets is missing.

In summary, the provided FDA letter confirms the clearance of the Paradigm System based on substantial equivalence but does not disclose the detailed performance study results or the specific acceptance criteria met by the device. These details would typically be found in the full 510(k) submission, which is not included here.

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The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories. The Paradigm System is used with an external monitor.

Acceptance Criteria and Study for Paradigm System

The Paradigm System, a stereotaxic image guidance system, underwent verification and validation activities to assure it meets performance requirements. The provided documentation highlights general functional and safety testing as well as cadaveric model studies. This response compiles the stated information regarding acceptance criteria and the supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding numerical performance metrics for the Paradigm System. Instead, it broadly states that "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions." The document lists the types of testing performed and the standards used, implying that the acceptance criteria are met by demonstrating compliance with these tests and standards.

The studies mentioned are:

• Non-Clinical Hardware, Software, and Instrumentation Verification Tests
• Non-Clinical Design Validation conducted in Cadaveric Model
• Cadaveric Simulated Workflow Study Assessing Usability
• Compliance Conformity Assessments

The conclusion states: "Performance, safety and usability testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness." This indicates that the device's performance was deemed acceptable relative to established safety and effectiveness benchmarks, likely derived from the predicate device and relevant standards.

2. Sample Size for Test Set and Data Provenance

The document states that a "Non-Clinical Design Validation conducted in Cadaveric Model" and a "Cadaveric Simulated Workflow Study Assessing Usability" were performed for testing.

• Sample Size: The exact sample size (number of cadavers or specific test cases) used for these cadaveric studies is not specified in the provided text.
• Data Provenance: The cadaveric studies are inherently prospective in their design, as they involve performing procedures on the cadavers in a controlled setting for the purpose of testing. The country of origin of the cadaveric data is not specified.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The mention of "Cadaveric Simulated Workflow Study Assessing Usability" suggests involvement of users (e.g., surgeons) in the evaluation, but details on ground truth establishment are absent.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.

6. Standalone Performance Study

The document refers to "Non-Clinical Hardware, Software, and Instrumentation Verification Tests" and "Non-Clinical Design Validation conducted in Cadaveric Model." While these indicate testing of the algorithm and system, it is not explicitly stated whether a "standalone (i.e., algorithm only without human-in-the-loop performance)" study was conducted. The nature of a stereotaxic image guidance system inherently involves integration with human procedural steps.

7. Type of Ground Truth Used

For the cadaveric studies, the specific type of ground truth used (e.g., expert consensus on target accuracy, direct measurement, pathology, outcomes data) is not explicitly stated. Given the device's purpose for spatial positioning and orientation, ground truth would likely involve highly accurate measurements of instrument tip position relative to anatomical targets within the cadaveric model, verified by a gold standard measurement technique.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set for any underlying algorithms within the Paradigm System. The description of the device's principle of operation mentions "fuses high-resolution, real-time camera imaging... with medical imagery (such as CT)" and "Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae," implying that algorithms are trained on such data.

9. How Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established.

In summary, while the document confirms that various tests were conducted to ensure the safety and effectiveness of the Paradigm System, detailed information regarding specific performance metrics, sample sizes for test and training data, expert qualifications, and ground truth establishment methods is largely absent in the provided text.

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Modus Nav is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The subject device, Modus Nav, is a modified version of its predicate, BrightMatter Guide with SurfaceTrace Registration. The system is a surgical planning and image guided surgical system that enables open or percutaneous computer-assisted cranial surgery. The system uses optical 3D tracking technology to display the location and orientation of tracked (also known as navigated) surgical instruments relative to the pre-operative scan images of the patient. The system consists of a software application installed on a computer, tracked surgical instruments, and accessories to enable the tracking of those instruments.

The planning functionality of the device is provided by an already cleared device called BrightMatter Plan 1.6.0 (K180394). The remaining functionality of the system can be broadly grouped into data preparation, registration and visualization of surqical tools. Data preparation and registration is performed during the initial stages of a surgical procedure and visualization of the tools is performed as needed during the surgical procedure.

General use of the system as an image guided surgical tool is composed of the following key steps:

• . Equipment setup
• . Plan selection and data preparation
• Patient registration .
• . Tool localization and visualization

An optical Tracking Camera provides the position and orientation of the tools with respect to the tracking origin. The navigated surgical tools are tracked using singleuse passive reflective markers (K033621) that are attached to the surgical tools prior to each surqical procedure. An external display can be used by the surgical staff if needed, given that the Tracking Camera mounted on a cart maintains a line of sight between the Cranial Reference and the Tracked Surqical Tools. Both the User Cart (also known as Navigation Cart) and Auxiliary Carts are placed outside the sterile field.

The primary purpose of this 510(k) submission is to introduce new navigated tools such as the Short Pointer, Shunt Stylet, and the corresponding Calibration Device. It also introduces new software features to support the navigation of these tools, the ability to navigate with Synaptive's Trackable Suction tools, and minor workflow improvements to facilitate the surgical procedure.

The provided text describes the Modus Nav system, a surgical planning and image-guided surgical system for neurosurgical cranial procedures. Below is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided document.

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BrightMatter Guide with SurfaceTrace Registration) rather than setting specific clinical performance metrics with target values for new device features. The acceptance criteria are largely centered around functional verification, safety, and equivalence to the predicate.

Additional Information Regarding the Study:

1. Sample size used for the test set and the data provenance:

   • Accuracy Characterization: An "accuracy measurement phantom of similar volume to an adult head" was used. The specific number of measurements or trials conducted on this phantom is not specified.
   • Algorithm pipeline verification: "Known data sets" or "truth data sets" were used. The size, type, or provenance (country of origin, retrospective/prospective) of these datasets is not detailed.
   • For other tests like software verification, human factors, and user acceptance, the "test set" refers to the specific test cases, scenarios, or participants involved, but detailed numerical sample sizes are not provided.

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

   • Accuracy Characterization: Ground truth for the accuracy phantom was "obtained using a Coordinate Measurement Machine (CMM)." This implies a metrology standard rather than human experts.
   • Algorithm pipeline verification: "Expert review of output generated by the pipeline" was used. However, the number of experts and their qualifications are not specified.
   • User acceptance testing and Human Factors Validation: These tests were conducted "by intended user in a simulated use environment" and "by intended users," respectively. While these "users" would be qualified medical professionals, their specific number and detailed qualifications are not provided.

3. Adjudication method for the test set:

   • The document primarily describes verification and validation activities rather than studies requiring adjudicator consensus (like clinical trials for sensitivity/specificity).
   • For the "Algorithm pipeline verification," it mentions "expert review of output," but does not detail an adjudication method (e.g., 2+1, 3+1).
   • For other tests, the "documentation results" simply state that acceptance criteria were met, implying direct pass/fail assessment rather than a multi-reader adjudication process.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing."

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

   • Algorithm pipeline verification: Yes, an "Automated performance verification of the core data processing facility of the software (known as 'algorithm pipeline'). Uses known data sets and expert review of output generated by the pipeline at various stages of processing." This suggests a standalone evaluation of the algorithm's output against known data.
   • Accuracy Characterization: This would also be considered a standalone performance test of the system's accuracy, without human interpretation of images directly impacting the accuracy measurement.

6. The type of ground truth used:

   • Accuracy Characterization: Ground truth was established using a "Coordinate Measurement Machine (CMM)" on an accuracy phantom, which is a physical measurement standard.
   • Algorithm pipeline verification: "Known data sets or 'truth data sets'" and "expert review" were used to establish ground truth for algorithm outputs. The nature of these "truth data sets" (e.g., expert consensus, pathology, simulated data) is not specified.
   • Software verification: Ground truth refers to the defined "software requirements specifications (SRS) items."

7. The sample size for the training set:

   • The document does not mention any training sets for machine learning models. The device's functionality as described primarily involves image-guided navigation based on optical tracking and pre-operative scans, rather than an AI/ML component requiring a separate training set for classification or detection tasks. The reference to "algorithm pipeline" suggests image processing, but no specific machine learning training is detailed.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set for machine learning is explicitly mentioned or described.

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The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical System Cranial Application is intended for use as a stereotaxic image guided surgical navigation system during cranial surgical procedures. The Cranial Application software assists in guiding surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The Cranial Application software works in conjunction with 7D Surgical Machine Vision Guidance System which consists of clinical software, optically tracked surgical Pointer, a reference frame instrument and platform/computer hardware which is substantially equivalent to K162375. Image guidance, or Machine Vision, tracks the position of instruments in relation to the surgical anatomy and identifies this position on DICOM scan images or intraoperative structured light images of the patient. The Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The 7D Surgical System Cranial Application is comprised of 5 major components:

1. Cart
2. Arm
3. Head
4. Tracked surgical 7D Surgical System Cranial Instruments
5. Software

The provided document, a 510(k) summary for the 7D Surgical System Cranial Application, outlines the device's acceptance criteria and the studies conducted to demonstrate its safety and effectiveness for FDA clearance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to predicate devices and meeting established safety and performance standards for image-guided surgical systems. The document doesn't provide specific quantitative "acceptance criteria values" in the format of a typical performance table (e.g., "accuracy must be

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The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the 7D Surgical System structured light scanner and/or user selected points. The system provides guidance data by tracking and displaying the position and orientation of wireless optically tracked Spinal Instruments including the 7D Surgical Pedicle Probe and Awl, now including the Medtronic Universal Drill Guide, relative to the patient. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery. Similar to the Medtronic Stealth Station, the system tracks the position and orientation of the Medtronic Universal Drill Guide.

The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.

The Tracking System enables the surgeon to view the position and orientation of 7D Surgical System Spinal Instruments relative to registered preoperative image data while performing the surgical procedure. Each of the 7D Surgical System instruments, including the Medtronic Universal Drill Guide, utilizes commercially available passive reflective marker spheres [Manufactured by NORTHERN DIGITAL, INC.; 510(k) K033621] to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other.

The Software links all system components and displays navigational data to the surgeon. lt provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration verification, and navigation.

Here's a breakdown of the acceptance criteria and study information for the 7D Surgical System, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a numerical sample size. The testing was conducted on "phantom models" in a "clinical simulated environment." The number of phantom models or specific test cases performed for accuracy is not quantified.
   • Data Provenance: The study was "non-clinical" and involved "phantom models." There is no indication of human patient data (retrospective or prospective) or country of origin for such data.

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

   • Not applicable as the study was non-clinical, using phantom models. Ground truth for accuracy was established through physical measurements ("measured physically or otherwise") rather than expert consensus on medical images or clinical outcomes.

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

   • Not applicable as the study was non-clinical, focusing on device accuracy measured against a physical ground truth, not requiring expert adjudication of interpretations.

4. 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 was a non-clinical performance study of a surgical navigation system's accuracy, not an MRMC study comparing human reader performance with or without AI assistance.

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

   • Yes, in a sense. The "Non-Clinical Accuracy" testing evaluated the system's accuracy (algorithm and hardware) in determining positional information against a ground truth on phantom models. While a human surgeon would ultimately use the system clinically, this specific test isolated the device's inherent navigational accuracy.

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

   • The ground truth for accuracy testing involved comparing the position reported by the image-guided surgery system to the "ground truth position measured physically or otherwise." This implies a physical measurement or established reference standard on the phantom models.

7. The sample size for the training set:

   • Not applicable. This document describes verification and validation activities for a new software compatibility feature (Medtronic Universal Drill Guide) for an existing surgical navigation system. It does not refer to a machine learning model that would require a distinct "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a training set for a machine learning algorithm.

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The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spationing and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical Envision 3D™: Image Guidance System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the Envision 3D™ integrated structured light scanner and/or user selected points. The system provides guidance data by displaying the locations of wireless optically tracked Envision 3D™ Spinal Instruments (examples include pedicle probe and awl) relative to the patient. Position and orientation data of tracked Envision 3D™ Spinal Instruments are linked to the preoperative scan data using the Envision 3D™ workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.

The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.

The Envision 3D™: Image Guidance System is comprised of 5 major components:

• 1. Cart
• 2. Arm
• 3. Head
• 4. Tracked surgical Envision 3D™ Spinal Instruments
• 5. Software

The provided text gives limited details about the acceptance criteria and a specific study proving the device meets them. However, it does mention non-clinical performance and accuracy testing. Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All accuracy specifications have been met" for the "Non Clinical Accuracy" testing. However, the specific numerical acceptance criteria for accuracy are not explicitly stated. It refers to ASTM F2554-10 for the measurement method but doesn't provide the targets.

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

• Test Set Sample Size: Not explicitly stated. The "Non Clinical Accuracy" testing was performed "on phantom models." The number of phantom models or specific test cases is not provided.
• Data Provenance: The Non-Clinical Accuracy tests were conducted on "phantom models" in a "clinical simulated environment." This indicates simulated, controlled environments rather than data from human patients. The country of origin of the data is not specified. It is a retrospective analysis of device performance on phantom models.

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

• Number of Experts: Not specified.

• Qualifications of Experts: Not specified.

  The ground truth for accuracy testing (Target Registration Error) is described as "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a measurement-based ground truth rather than expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable/Not specified. The accuracy testing described appears to be objective, measurement-based (comparing system output to physical ground truth), rather than requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document states, "A clinical trial was not required to demonstrate safety and effectiveness of the Envision 3D™: Image Guidance System. Clinical validation is unnecessary as the Envision 3D™: Image Guidance System introduces no new indications for use, device features are equivalent to the previously cleared predicate device identified." Therefore, no assessment of human reader improvement with AI assistance was conducted or reported.

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

The "Non Clinical Accuracy" testing refers to the "System's accuracy" using the Envision 3D™ on phantom models. This implies a standalone evaluation of the device's accuracy without a human-in-the-loop performance assessment. The system's ability to spatially position and orient surgical instruments is the core function being tested.

7. The Type of Ground Truth Used

The ground truth used for "Non Clinical Accuracy" testing, specifically for Target Registration Error (TRE), is described as "the ground truth position measured physically or otherwise." This suggests physical measurement or pre-defined true positions on the phantom models, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide information about a training set specifically for an AI/algorithm component. The device is referred to as an "Image Guidance System" utilizing an "integrated structured light scanner" and "software" that "links all system components," but it does not detail any machine learning or AI models requiring a distinct training dataset. The system seems to rely on established image processing and tracking algorithms rather than a trainable AI model in the context usually meant by "training set" for AI.

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

Since no separate training set or AI model requiring traditional training data is explicitly described, this information is not applicable or provided in the document.

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BrightMatter Guide with SurfaceTrace Registration is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the system is suitable for their needs.

The subject device, BrightMatter Guide with SurfaceTrace Registration is a modification of the software component of BrightMatter Navigation system that is presented in K142024. The system is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. In particular, the device is suitable for neurosurgical cranial procedures. The planning functionality of the device is provided by an already cleared device, BrightMatter Planning (K140337). The remaining system provides a sequence of discrete workflow activities (or phases) that guide a surgeon through the process of data preparation for the surgical procedure. Then the device aids the surgeon in visualizing the location of the surgical tools relative to clinical images and physical location of the patient.

Following is a summary of steps involved in data preparation and registration of the patient's head position relative to pre-surgical clinical images:

• . Importing plan and imaging data
• Reviewing and selecting a previously generated surgical plan .
• . Optionally fusing (merging or co-registering) additional imaging data
• Registering the clinical images to the patient using either Point registration or . SurfaceTrace based registration.

Following steps are provided as visualization tools during the execution of the surgical procedure:

• . Aid in visualizing location of the surgical site as planned by the surgeon (using BrightMatter Planning software, K140337)
• . For trajectory-centric procedures, help visualize insertion of tracked surgical tools by identifying location of surgical tool's position and orientation relative to clinical images and the surgical plan developed by the surgeon
• . Visualize location of tracked surgical tools after the intended target location has been reached
• . The purpose of this 510k submission is introduce a new registration methodology using changes that are limited to the software component of the previously cleared system. Key functional components of the system are an optical tracking sub-system, navigated surgical tools, custom software application and an external display. The navigated surgical tools are tracked using single-use passive reflective markers (K033621) that are attached to the surgical tools prior to each surgical procedure.

The surgical display and tracking camera are mounted on an Auxiliary Cart. The computer is housed in a Navigation Cart. These components have been cleared as part of the BrightMatter Navigation system (K142024).

As with many systems in the OR, not all components need to be sterile during use. The only subcomponents that come in contact with the patient are the Pointing Tool, Port Reference Tool and Calibration Block. These tools fit in the limited contact duration category. The tools have been cleared as part of the BrightMatter Navigation system (K142024).

Here's a breakdown of the acceptance criteria and study information for the BrightMatter Guide with SurfaceTrace Registration device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details:

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

   • Test Set Sample Size: The document refers to an "accuracy measurement phantom of similar volume to an adult head." It does not specify a numerical sample size for individual measurements on this phantom but implies a comprehensive set of measurements taken at various locations (center and boundaries of the tracking volume).
   • Data Provenance: The study was conducted internally by Synaptive Medical Inc. in Canada (based on the submitter's address). The data is prospective in the sense that the testing was performed on the device to characterize its performance for this submission.

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

   • The ground truth for the test set (the accuracy measurement phantom) was established using a Coordinate Measurement Machine (CMM). This implies mechanical measurement, not expert human assessment directly for the ground truth of the phantom. No human experts are explicitly mentioned as establishing the ground truth for the CMM measurements themselves.

3. Adjudication Method for the Test Set:

   • Not applicable. The ground truth for the phantom was established by a CMM, an objective mechanical measurement, not through human consensus.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The testing focused on the standalone accuracy and performance of the device's new registration method. The "Design Validation" mentions simulated use with intended users, but this is described as confirming substantial equivalence and not an MRMC study measuring reader improvement with AI assistance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, a standalone performance evaluation was conducted. The "Characterization of system accuracy" section directly assesses the device's ability to measure positional and angular errors using the SurfaceTrace registration method on an accuracy phantom, explicitly stating "Positional error was measured to be less than 2 mm and angular error was measured to be less than 2 degrees." This is an algorithm-only assessment of the core accuracy of the registration.

6. Type of Ground Truth Used:

   • Mechanical Measurement (CMM): The ground truth for the accuracy phantom was obtained using a Coordinate Measurement Machine (CMM).

7. Sample Size for the Training Set:

   • The document does not specify the sample size for any training set. It describes a modification to the software component of a previously cleared device and focuses on the performance characterization of the new SurfaceTrace Registration method. This submission is for a modification, and while the underlying BrightMatter Navigation system would have had development, the details of its training data are not provided here.

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

   • Since the document does not specify a training set sample size or details about a training set, it does not provide information on how its ground truth was established.

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BrightMatter Navigation System is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

The subject device, BrightMatter Navigation system, is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. In particular, the device is suitable for neurosurgical cranial procedures. The planning functionality of the device is provided by an already cleared device, BrightMatter Planning (K140337). The remaining system provides a sequence of discrete workflow activities (or phases) that guide a surgeon through the process of data preparation for the surgical procedure. Then the device aids the surgeon in visualizing the location of the surgical tools relative to clinical images and physical location of the patient.

Following is a summary of steps involved in data preparation and registration of the patient's head position relative to pre-surgical clinical images:

• Importing plan and imaging data
• Reviewing and selecting a previously generated surgical plan
• Optionally fusing (merging or co-registering) additional imaging data
• Preparing and executing point-based registration

Following steps are provided as visualization tools during the execution of the surgical procedure:

• Aid in visualizing location of the surgical site as planned by the surgeon (using BrightMatter Planning software, K140337)
• For trajectory-centric procedures, help visualize insertion of tracked surgical tools by identifying location of surgical tool's position and orientation relative to clinical images and the surgical plan developed by the surgeon
• Visualize location of tracked surgical tools after the intended target location has been reached

Key functional components of the subject device are an optical tracking sub-system, navigated surgical tools, custom software application and an external display. The navigated surgical tools are tracked using single-use passive reflective markers (K033621) that are attached to the surgical tools prior to each surgical procedure.

The surgical display and tracking camera are mounted on an Auxiliary Cart. The computer is housed in a Navigation Cart.

As with many systems in the OR, not all components need to be sterile during use. The only subcomponents that come in contact with the patient are the Pointing Tool, Port Reference Tool and Calibration Block. These tools fit in the limited contact duration category.

Here's a breakdown of the acceptance criteria and study information for the BrightMatter Navigation System v1.0, based on the provided FDA 510(k) document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of "samples" in a traditional clinical sense. The accuracy testing was conducted using a "measurement phantom" that mimicked brain volume.
• Data Provenance: The document does not specify the country of origin for the phantom data. The study was a non-clinical study, primarily involving engineering and system performance testing.

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

• Number of Experts: Not applicable. The ground truth for the accuracy testing was established using a Coordinate Measurement Machine (CMM), which is a precision metrology instrument, not human experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by CMM measurements, not human consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
• Effect Size: Not applicable. The device is a navigation system for surgical guidance, not an AI diagnostic tool primarily evaluated by human reader performance on a diagnostic task.

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

• Standalone Performance: Yes, the described accuracy testing (positional and angular error) is a form of standalone performance evaluation for the tracking and guidance algorithm. It assesses the device's inherent measurement capabilities without direct surgeon interaction in the measurement process (though it simulates surgical workflow via CT images of the phantom).

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the accuracy testing was established by Coordinate Measurement Machine (CMM) measurements on a measurement phantom. This provides high-precision physical measurements. In addition, for biocompatibility testing, established laboratory standards and measurement techniques were used to determine results.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information about a "training set" in the context of an AI/machine learning model. The BrightMatter Navigation System is described as using an "optical tracking sub-system" and software for guidance. It's not explicitly stated to be an AI/ML device in the sense of requiring a large training dataset for model development. The software development follows a standard Software Development Life Cycle.

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

• Ground Truth for Training Set: Not applicable, as there's no explicit mention of a training set or AI/ML model training in the conventional sense. The "training" of such a system would typically involve calibrating the optical tracking hardware and validating the software algorithms against known physical parameters, where the "ground truth" would be the precisely known physical dimensions and positions.

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