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The 7D Surgical System Percutaneous Application is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical 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 minimally invasive spine surgery. The system performs Percutaneous image guided surgery by acquiring an intra-operative tomographic scan of the patient with the 7D Surgical Flash Frame attached to the patient's skin over the incision drape in the region of interest where the spine surgery is to be performed. In addition, the intra-operative tomographic scan is taken with the 7D Surgical Reference Frame rigidly attached to either the spine or iliac crest. The 7D System then generates a three-dimensional (3D) image of the surgical site and the 7D Flash Frame. Registration is performed by the system software registering points from the 7D Flash Frame generated from the 3D intra-operative tomographic scan to the 3D structured light image generated by the system.

The provided document describes the 7D Surgical System - Percutaneous Application (7D Flash Frame), a stereotaxic image guidance system for spinal surgery. The safety and effectiveness of this device are demonstrated through non-clinical performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "All accuracy specifications have been met for the Percutaneous Application" and "All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device." However, specific numerical acceptance criteria (e.g., a defined threshold for Target Registration Error) and the exact reported device performance values against these criteria are not explicitly provided in the given text. The table above can only reflect the general qualitative statements made.

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

• Sample Size for Test Set: Not specified. The document mentions "phantom models" for accuracy testing but does not provide details on the number of phantoms, tests, or specific scenarios.
• Data Provenance: The testing was "conducted on phantom models in a simulated environment." This indicates simulated data rather than patient data. The country of origin of the data is not specified but given the company's location, it's likely Canada. The study was prospective as it involved conducting new tests.

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

Not applicable/Not specified. The ground truth for the "Non-Clinical Accuracy" testing using "Target Registration Error (TRE)" was established by "the ground truth position measured physically or otherwise." This implies a physical measurement standard on the phantom model rather than expert opinion. Therefore, no human experts were explicitly used to establish ground truth for the accuracy measurements described.

4. Adjudication method for the test set:

Not applicable/None specified. As the ground truth was established through physical measurements on phantom models, there's no mention of human adjudication for the test set results.

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. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System. Clinical validation is unnecessary as the 7D Surgical System introduces no new indications for use, and device features are equivalent to the previously cleared predicate device identified." This indicates that no human readers or clinical subjects were involved, and therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted.

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

Yes, implicitly. The "Non-Clinical Accuracy" testing, particularly the "Target Registration Error" evaluation on phantom models, describes the performance of the system (algorithm and hardware) in a simulated environment without human surgical intervention being part of the performance measurement itself. The system's ability to register and track accurately in this controlled setting represents its standalone performance.

7. The type of ground truth used:

The ground truth used for the "Non-Clinical Accuracy" testing was the "ground truth position measured physically or otherwise" on phantom models. This is a form of physical measurement/reference standard in a simulated environment.

8. The sample size for the training set:

Not specified. The document focuses on verification and validation testing and does not provide information about a separate training set or its sample size for the device's development or machine learning components (if any, though the "structured light images" and "DICOM data" suggest image processing and registration).

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

Not specified. As the training set details are not provided, how its ground truth was established is also not mentioned.

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The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical 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 7D Surgical 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.

The 7D Drill Guide is designed to allow the 7D Spine Module to show real-time interaction of the drill guide with the patient. The 7D Drill Guide is used to extend the initial hole through the cancellous (soft) bone of the vertebra passing the pedicle. The 7D Drill Guide Instrument Set contains several inserts and bits, these can be switched during the procedure. During navigation, the 7D Drill Guide is displayed showing the trajectory of its path, including measurement markings for measuring the depth of the proposed insertion. These measurement markings can be used as a guide to select the appropriate length of the screw for instrumentation.

The provided text describes the 7D Surgical System - Drill Guide and its submission for 510(k) clearance. Here's a breakdown of the acceptance criteria and the study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models". This indicates that the testing was performed on non-human models, likely in a laboratory setting. No specific sample size (number of phantom models or tests) is mentioned, nor is the country of origin for the data, but it is implied to be from 7D Surgical Inc. in Canada. The testing is non-clinical, so it's not "retrospective or prospective" in the traditional sense of human data.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the non-clinical tests. However, it references ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. This standard likely dictates methods for establishing ground truth, typically involving highly precise measurement instruments and potentially expert calibration. The ground truth for Target Registration Error (TRE) and Absolute Target Error (ATE) involves comparing the system's reported position to a physically measured or otherwise established true position.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. Given that the testing was non-clinical on phantom models, ground truth would likely be established through precise measurements rather than expert consensus requiring 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 7D Surgical System." Therefore, there is no discussion of human readers, AI assistance, or effect sizes in this context.

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

Yes, the document describes standalone performance testing for the device. The non-clinical accuracy tests, including those following ASTM F2554-10 and the evaluation of Target Registration Error (TRE) and Absolute Target Error (ATE), are conducted on the device itself (the 7D Surgical System and its Drill Guide) without active human surgical intervention during the measurement of accuracy. The goal is to determine the system's inherent accuracy in positioning and orientation.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical accuracy tests was established through:

• Precise physical measurements: For evaluating absolute accuracy, repeatability, and navigation accuracy according to ASTM F2554-10.
• Comparison to a known true position: For Target Registration Error (TRE) and Absolute Target Error (ATE), which involve comparing the system's reported position to a physically or otherwise established ground truth position on phantom models.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI algorithms. The 7D Surgical System is described as a "stereotaxic image guidance system" that uses "optically tracked reflective marker spheres" and "structured light scanner" for registration and tracking. This suggests a traditional computer vision/navigation system rather than one based on deep learning requiring a large training dataset.

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

As no training set (in the machine learning sense) is mentioned or implied, there is no information on how its ground truth would have been established.

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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 Biopsy and Ventricular Catheter Placement 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 Ventricular Catheters placement. 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 K181041. Image guidance tracks the position of instruments in relation to the surgical anatomy and identifies this position on DICOM 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, 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 7D Surgical System Cranial Instruments
5. Software

Here's a breakdown of the acceptance criteria and study information for the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document states that device performance tests were conducted "on phantom models in a clinical simulated environment." It does not specify the exact sample size (number of phantom models or individual measurements) for the TRE and ATE testing.
   • The data provenance is from non-clinical studies conducted by 7D Surgical Inc. There is no information regarding country of origin for the data or if it was retrospective or prospective in the context of clinical data, as this was a non-clinical study.

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

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the non-clinical phantom model testing. It mentions that TRE and ATE evaluate "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 physical measurement standard was used as ground truth rather than expert consensus on images.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by physical measurement on phantom models, not by expert review requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is a surgical navigation system, not an AI-based diagnostic imaging tool that would typically involve human readers interpreting images. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application."

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

   • The "Non-Clinical Accuracy" testing, specifically the TRE and ATE measurements on phantom models, represents a standalone performance evaluation of the system's accuracy in tracking and reporting positions without a human surgeon's interaction being part of the measurement of error. The system itself is designed to be used with a human surgeon.

6. The type of ground truth used:

   • For the non-clinical accuracy testing (TRE and ATE), the ground truth was established by physical measurement on phantom models. The document states it's "the ground truth position measured physically or otherwise."

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning. The 7D Surgical System uses "Machine Vision Guidance System" and structured light imaging. While these technologies involve algorithms, the submission focuses on the performance verification of the integrated system and its components. It does not detail the development or training of specific machine learning models with a distinct training dataset.

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

   • As no specific "training set" for machine learning is detailed in the document, information on how its ground truth was established is not provided. The system uses pre-calibrated geometry of instruments and structured light scanning, which inherently rely on engineering and metrological standards for accuracy rather than a labeled training dataset in the typical AI sense.

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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 Universal Tracking Clamp, 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 previously cleared 7D Surgical System and Brainlab, the system tracks the position and orientation of a Universal Tracking Clamp.

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 Universal Tracking Clamp, utilizes commercially available passive reflective marker spheres 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, registration verification, and navigation.

The 7D Surgical Universal Tracking Clamp consists of two different size tracking arrays which hold the reflective marker spheres both with a unique marker arrangement to distinguish one from the other. The tracker arrays attach to two different clamps of different sizes which attach to 30 party spinal surgical instruments. The Universal Tracking Clamp when attached to 30 party spinal instruments requires calibration in order to accurately display the position and orientation of the tool in the 7D Surgical System software.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical performance testing conducted on phantom models. It does not specify a numerical sample size (e.g., number of cases or runs) for the accuracy testing.

• Data Provenance: The testing was conducted internally by 7D Surgical, Inc. on phantom models, simulating clinical use. There is no mention of country of origin for data as it's a simulated environment, nor whether it's retrospective or prospective, as it's not a human clinical study.

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

This information is not provided in the document. The ground truth for the non-clinical accuracy testing was established by physical measurements or "otherwise" in a simulated environment, not through expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established through physical measurements on phantom models, not through expert review requiring adjudication.

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

No, an MRMC comparative effectiveness study was not performed and is not mentioned. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The described non-clinical accuracy testing is a form of standalone performance evaluation for the device's ability to track and display positions accurately on phantom models. While it involves a human operator using the system, the focus of the accuracy tests (Target Registration Error, Angular Trajectory Error, and ASTM F2554-10 compliance) is on the system's intrinsic measurement and navigation capabilities, separate from overall human surgical outcomes. Therefore, it implicitly evaluates the algorithm's performance in determining position and orientation.

7. Type of Ground Truth Used

For the non-clinical accuracy testing:

• Physical Measurement: The document states that Target Registration Error (TRE) and Angular Trajectory Error (ATE) evaluate the error discrepancy between the position reported by the image-guided surgery system and the "ground truth position measured physically or otherwise." This indicates that a physically measured gold standard was used on the phantom models.
• ASTM F2554-10 Standard: Compliance with this standard also implies a defined method for establishing ground truth for positional accuracy.

8. Sample Size for the Training Set

The document does not specify a training set sample size or details about a training set. As this is a device for image-guided surgery (navigation), rather than an AI-driven diagnostic or predictive algorithm learning from large datasets, the concept of a "training set" in the context of machine learning is not directly applicable here. The system uses algorithms for structured light scanning, image registration, and tracking, but these are typically developed and validated through engineering principles and specific test cases rather than large-scale data training.

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

Since a "training set" in the context of machine learning is not explicitly mentioned or applicable to the type of device described, this information is not provided. The device's underlying algorithms and functionalities would have been developed and tested against engineering specifications and internal validation criteria.

Ask a specific question about this device

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 IZI Pedicle Access Kit, 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.

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 IZI Pedicle Access Kit, utilizes commercially available passive reflective marker spheres 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. It provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration, registration verification, and navigation.

The provided text does not contain information about an AI/ML-driven device or study. It describes a 510(k) premarket notification for the "7D Surgical System," which is a stereotaxic image guidance system intended for spatial positioning and orientation of neurosurgical instruments and as a primary surgical luminaire during image-guided surgery. This system appears to be a hardware and software system for surgical navigation, not an AI/ML diagnostic or prognostic tool.

Therefore, many of the requested details regarding acceptance criteria, training/test sets, expert ground truth, MRMC studies, and standalone algorithm performance, which are typical for AI/ML validation, are not applicable or described in this document.

However, I can extract information related to the device's performance testing and general acceptance criteria as described for this non-AI system.

Here's an attempt to answer based on the provided text, highlighting what is missing or not applicable:

1. A table of Acceptance Criteria and the Reported Device Performance:

The document describes performance in terms of verification and validation activities, particularly accuracy.

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

• Sample Size: The document mentions "phantom models" for non-clinical accuracy testing. It does not specify a numerical sample size (e.g., number of phantoms, number of measurements per phantom).
• Data Provenance: The studies were "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models" and "Non-Clinical Accuracy" tests on phantom models in a "clinical simulated environment." This indicates the data is synthetic/simulated, not from real patient cases. No information on country of origin for this simulated data.
• Retrospective or Prospective: Not applicable as it's non-clinical, phantom-based 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 in the document. Given that the testing was "Non-Clinical Accuracy" on "phantom models" and describes "Target Registration Error (TRE)" as a comparison between the system's reported position and "ground truth position measured physically or otherwise," it's highly likely the ground truth was established through precise physical measurements using metrology tools, not human expert consensus, for this mechanical/optical navigation system.

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

• Not applicable/Not mentioned. This concept (adjudication for discordant interpretations) typically applies to human readers interpreting medical images or data, not to the performance measurement of a surgical navigation system's mechanical/optical accuracy on phantoms.

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 study was performed or described. The device is a surgical navigation system, not an AI diagnostic/prognostic tool that assists human image readers. Clinical data (and thus human reader studies) were deemed "unnecessary" because the device introduces "no new indications for use" and its features are "equivalent to the previously cleared predicate device."

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

• The document describes "Non-Clinical Accuracy" testing of the "System's accuracy... on phantom models." This testing measures the system's ability to accurately track and report positions relative to a physical ground truth, which can be considered a standalone performance assessment of the navigation component. The device's primary function is to provide guidance (essentially "standalone" positional data) that a human surgeon then uses. The document states, "TRE evaluates 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 direct algorithmic measurement comparison.

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

• For "Non-Clinical Accuracy," the ground truth was established through "physical measurements" or "otherwise" on "phantom models." This is evident from the description of Target Registration Error (TRE) as comparing the system's reported position to the "ground truth position measured physically or otherwise." It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable/Not mentioned. This device does not appear to be an AI/ML system that requires a "training set" in the conventional sense for model development. The system's operation is based on structured light sensing and optical tracking of physical markers.

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

• Not applicable. As a non-AI/ML system, there is no "training set" for which ground truth would need to be established in the context of machine learning model training.

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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

Ask a specific question about this device

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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