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The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab Navigation System.

The Virage® Navigation System is comprised of nonsterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. The Virage Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software (version 2.0 and higher). The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. The Virage Navigation System is also compatible with the Zimmer Biomet Universal Power System.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Virage® Navigation System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a comprehensive clinical study in the format requested.

Here's a breakdown of the information that can be extracted or inferred from the provided text, along with what is not available:

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

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

This information is not provided in the document. The document mentions "verification and validation activities" but does not detail the sample sizes for these tests, nor the data provenance. These are typically included in the full 510(k) submission, but not in this summary letter.

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. The document mentions "usability" but doesn't specify if experts were involved in establishing ground truth for any performance metrics.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device in question is a navigation system for surgical procedures, not an AI diagnostic tool that human readers would interpret. The goal is to assist surgeons, not necessarily "improve human readers." The study described is a performance assessment of the navigation system itself.

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

The studies mentioned ("positional accuracy, usability, and tolerance analysis") appear to be evaluating the device performance, which is inherently a "standalone" evaluation of its mechanical and computational capabilities. However, these are not directly comparable to "algorithm only" performance for AI diagnostic tools. The device's function is to assist in surgical navigation, which implies it is always with a human in the loop during actual use.

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

The document mentions "positional accuracy." For this, the ground truth would likely be established through precise measurements using calibrated instruments or imaging techniques to determine the true position relative to the navigated object. However, the specific method of establishing this ground truth is not detailed. For "usability," the ground truth would be user feedback and observation against predefined tasks.

8. The sample size for the training set

This information is not provided in the document. The Virage® Navigation System, as described, is a mechanical and software-based navigation tool, not an AI/ML-driven diagnostic device that typically undergoes a separate "training set" for model development. The "training" for such systems would involve software development and testing rather than data-driven machine learning model training.

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

As there is no mention of a "training set" in the context of an AI/ML model, this information is not applicable as per the provided document. If there are underlying algorithms that use data to improve, those details are not present here.

In summary:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It confirms that the device met specified acceptance criteria for various performance aspects (positional accuracy, usability, tolerance analysis, packaging, sterilization, cleaning, and material biocompatibility). However, it does not provide the detailed study design, sample sizes, expert qualifications, or ground truth establishment methods typically found in a clinical study report for an AI/ML diagnostic device. The device itself is a surgical navigation system, not a diagnostic AI.

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The Vital Navigation System instruments are used during the preparation and placement of the Vital vy System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System.

The Vital™ Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. Both combinations are used to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality Screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. The use of these navigation systems provides the surgeon access to real-time multi-plane 3D images) providing confirmation of hardware placement.

The provided text states that the Vital™ Navigation System underwent performance testing, including positional accuracy, usability, and tolerance analysis, and that all met the acceptance criteria when the Vital Navigation instruments were attached to the ZimVie reference arrays.

However, the document does not provide a specific table of acceptance criteria or the reported device performance values for these tests. It also does not detail the study design elements like sample sizes, data provenance, expert qualifications, or the use of MRMC studies.

Therefore, for aspects not explicitly stated in the document, I will indicate "Not specified in the document."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document states that these tests were performed and met the criteria, but the specific metrics or values for the acceptance criteria and the performance are not provided.

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

• Sample size: Not specified in the document.
• Data provenance (country of origin, retrospective/prospective): Not specified in the document.

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

• Not specified in the document. The testing described (positional accuracy, usability, tolerance analysis) seems to be related to the device's technical specifications rather than the generation of clinical ground truth by experts for classification tasks.

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

• Not specified in the document.

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, an MRMC comparative effectiveness study is not mentioned as having been performed. The device is a "Stereotaxic Instrument" and "Navigation System," which aids surgeons in locating anatomical structures and placing screws. It is not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting images.

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

• The device is a "Navigation System" used with human surgeons. It's an instrument assisting a human operator, not a standalone algorithm making autonomous decisions or interpretations that would have an "algorithm only" performance metric in the traditional sense of AI diagnostics. The "positional accuracy" testing would be the closest analogue to a standalone performance metric for a navigation system, indicating its inherent precision.

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

• The nature of the "ground truth" for a navigation system's performance would primarily be related to its engineering precision and accuracy (e.g., actual vs. measured positions, successful and precise placement in simulated or cadaveric models during testing). The document refers to "positional accuracy," "usability," and "tolerance analysis," which imply engineering and usability testing rather than a clinical ground truth established by medical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set:

• Not applicable/Not specified. This device is not described as an AI/ML-based system that undergoes a "training" phase with a dataset. Its performance is validated through engineering and usability testing.

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

• Not applicable. As noted above, this device does not appear to be an AI/ML-based system with a training phase.

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The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. TELIGEN Clear, when used with UNAS, can be precalibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

The TELIGEN Procedure Kit and the TELIGEN Procedure Kit Pro are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery and navigation.

The TELIGEN Procedure Kit and the TELIGEN Procedure Kit Pro include a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments. Additionally, the TELIGEN Procedure Kit Pro includes an Access Probe as well as the instruments included in the TELIGEN Procedure Kit.

TELIGEN Access Probe and TELIGEN Clear are part of the DePuy Synthes Navigation Ready Instruments Portfolio and are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

The provided document, K223108 for the TELIGEN System, primarily focuses on the substantial equivalence of physical medical devices (TELIGEN Access Probe and TELIGEN Clear) which are "Navigation Ready Instruments" used in spinal procedures. It does not describe a study involving an AI/Machine Learning device or software, nor does it provide the detailed performance data, acceptance criteria, ground truth establishment, or study methodologies typically associated with such systems.

Therefore, I cannot extract the information required to populate the fields related to an AI/ML device study, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies.

The document discusses performance data related to the physical instruments:

• Accuracy Verification: Fulfillment of navigation systems instrument accuracy requirements, Instrument Length Comparison to Predicate Device, Array Characteristics Comparison to Predicate Device.
• Rigidity of Connections and Instrument during Use
• CAD Model Evaluation
• Simulated Use Evaluation

These are engineering and mechanical performance tests for physical instruments, not an AI/ML algorithm's diagnostic or assistive performance.

In summary, the provided text does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI/ML device.

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The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients' relevant rigid anatomical structures can be clearly identified on the imaging.

The BNS is comprised of the Bolt Navigation Unit (BNU) (an iPod touch® mobile digital device with the Bolt navigation software loaded on it), the Bolt single use case, and sterile drape. The BNS is intended to provide navigational guidance during spine surgery. The system uses preand perioperative imaging data, and input from the surgeon via the BNU touchscreen to construct the proper angular position of the instrumentation and implants relative to gravity, and communicates this information to the surgeon via the BNU screen attached to the instrument allowing the surgeon to look at both the surgical site and the navigation data at the same time, thus attenuating the risk of attention shift. The BNS provides guidance data by displaying the angular orientation of a surgical instrument (such as a pedicle probe or awl) relative to a surgeon selected entry point on the patient and gravity. Angular orientation of the instruments is linked to the imaging data via the BNS. The system is intended to be used for both image fusion and navigation for spine surgery applications where reference to relevant rigid structures can be identified relative to a perioperative image data of the anatomy and the gravity vector.

Here's an analysis of the acceptance criteria and study details for the Bolt Navigation System ("BNS"), based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set (Cadaveric Trajectory Accuracy Study): The document doesn't explicitly state the number of cadavers or individual screw placements used in the cadaveric study. However, the results are presented as overall accuracy, testing levels T9 to S1 (thoracolumbar and sacral spine).
   • Data Provenance: The cadaveric study is a non-clinical test, implying it was conducted in a controlled lab setting, likely in the country of the manufacturer or test facility. It is a prospective study in the sense that the data was generated specifically for this validation.

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

   • The document does not provide information on the number of experts or their qualifications used to establish ground truth for the cadaveric study.
   • For the cadaveric study, "Planned trajectory vs actual placement accuracy" was assessed, but the method for determining "actual placement" (e.g., post-insertion imaging, dissection measurement) and who evaluated it is not detailed.

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

   • The document does not specify an adjudication method for the cadaveric study.

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:

   • A formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not explicitly detailed in the provided summary.
   • A "multi-surgeon clinical study" was conducted, but its results are only summarized as supplementary information to show the device performs as intended, not as a comparative effectiveness study against a non-AI control group with quantifiable improvement.

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

   • The "Clinical phantom accuracy results" represent a standalone performance assessment of the system against a known phantom, demonstrating the system's inherent accuracy in a controlled environment. The mean accuracy was 0.35 degrees.
   • The "Cadaveric accuracy results" also reflect the algorithm's performance in a more realistic surgical simulation, where surgical instruments guided by the BNS were evaluated for accuracy of placement against a planned trajectory. While a human surgeon uses the system, the
   • accuracy measurement itself quantifies the system's guidance.

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

   • Clinical Phantom Accuracy: The ground truth for the phantom study would be the known, precisely manufactured dimensions and orientations of the phantom, which the device is designed to measure.
   • Cadaveric Trajectory Accuracy Study: The ground truth for this study is described as "Planned trajectory vs actual placement accuracy." The "planned trajectory" would be established pre-procedure (likely by a surgeon using imaging), and the "actual placement" would be measured post-procedure using a precise method (e.g., high-resolution CT, C-arm imaging, or physical measurement) to determine the deviation from the plan. The specific method for determining "actual placement" (which serves as the "truth") is not detailed.

7. The sample size for the training set:

   • The document does not provide information on the sample size of any training set used for the BNS software. The BNS utilizes "pre- and perioperative imaging data" and "intraoperative fluoroscopic and pre-operative MRI or CT axial images," suggesting it may rely on existing imaging data for its functionality, but details about supervised machine learning training, if any, are absent.

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

   • Since the document does not specify a training set or the use of machine learning that would require a distinct training set with ground truth, this information is not available. The system appears to be more of a navigation system based on physical principles and image registration rather than a deep learning model requiring extensive annotated training data.

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The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The universal adaptors are specifically designed for use with the Zimmer Biomet ROSA One System, which is indicated for providing spatial positioning and orientation of instrument holders or tool guides based upon an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The ROSA One Spine System is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.

The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vitality MIS), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.

The provided text describes the Zimmer Biomet Universal Navigation System and its 510(k) clearance. However, it does not contain specific details about acceptance criteria, a detailed study proving performance against those criteria, or the methodology (sample size, expert qualifications, ground truth, MRMC study, standalone performance) typically associated with a robust clinical or technical validation study for an AI/ML medical device.

The closest information provided is:

• "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments was performed in accordance ASTM F2554-18 Standard Practice For Measurement of Positional Accuracy of Computer Assisted Surgical Systems."
• "Clinical data was not needed for the Zimmer Biomet Universal Navigation System."

This indicates that the validation was focused on the system's positional accuracy and relied on a standardized test method (ASTM F2554-18), rather than a clinical study evaluating diagnostic or treatment outcomes with human readers.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered from the provided text:

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

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 for test set: Not specified. The document mentions "accuracy testing" but does not detail the number of trials, cases, or specific measurements performed.
• Data provenance: Not applicable in the context of clinical data, as it states "Clinical data was not needed." For the accuracy testing, the "data" would be the measurements taken during the experimental procedure according to ASTM F2554-18. The origin of this experimental setup is not stated.

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)

• Not applicable. The validation was a technical accuracy test, not a clinical study requiring expert interpretation of medical images or outcomes.

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

• Not applicable. There was no clinical test set requiring adjudication.

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, "Clinical data was not needed for the Zimmer Biomet Universal Navigation System." Therefore, an MRMC study and AI assistance comparison were not conducted.

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

• Yes, implicitly. The "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments" performed per ASTM F2554-18 is a standalone technical performance test of the device's ability to measure spatial positioning accurately, independent of human interpretation of clinical outcomes. However, the specific metrics of this standalone performance are not reported.

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

• For the accuracy testing, the ground truth would be based on precisely established physical reference points and measurements in a controlled environment, as defined by the ASTM F2554-18 standard for measuring the positional accuracy of computer-assisted surgical systems. It's a "physical ground truth" related to spatial measurement, not a biological or clinical ground truth.

8. The sample size for the training set

• Not applicable. This device is a navigation system, not an AI/ML algorithm that requires a training set in the conventional sense (e.g., for image classification or risk prediction). Its "training" would be its engineering design and calibration.

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

• Not applicable, as there isn't a "training set" for an AI/ML algorithm in this context.

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SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of SYMPHONY OCT System is indicated.

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.

The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes tracking arrays supplied by the navigation system manufacturer. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, requires manual calibration with the Medtronic StealthStation navigation system.

SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set contains the Navigation Ring ST used to aid in determining the correct location and trajectory of spinal instruments and implants. The Navigation Ring ST has an interface between the Medtronic StealthStation® navigation system and the DePuy Synthes Navigation Ready Instruments.

The Navigation Ready Instruments include drills, trocar, probe, taps and screwdriver. When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Passive Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated with the Medtronic StealthStation navigation system.

This document describes the FDA's 510(k) clearance for the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set. The key aspects regarding acceptance criteria and supporting studies are extracted below.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed numerical results for the performance tests. The conclusion of substantial equivalence implies that the device met the necessary performance standards to be considered safe and effective as its predicate.

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

The document does not specify the exact sample sizes (e.g., number of instruments, number of measurements) for the accuracy verification tests or the simulated use evaluation.
The data provenance for the test set (e.g., country of origin, retrospective/prospective) is not explicitly stated. However, given it's a pre-market notification for a medical device seeking FDA clearance, the testing would typically be conducted under controlled laboratory conditions rather than using patient data. The simulated use evaluation used "sawbones models," which are synthetic bone models, indicating a prospective, lab-based study.

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

The document does not mention the use of experts to establish ground truth for the test set. The accuracy verification likely relied on engineering measurements against known specifications, and the simulated use evaluation would have been assessed by engineering and potentially clinical staff involved in the study.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication for establishing ground truth is not mentioned as part of the performance data.

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

No, an MRMC comparative effectiveness study was not done. The document describes a technical and simulated use evaluation rather than a clinical study involving human readers or a comparison of human performance with and without AI assistance. The device is a surgical instrument set, not an AI-based diagnostic tool.

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

Yes, in a sense. The "performance data" sections (Accuracy Verification, Implant/instrument mating, Simulated Use Evaluation) represent the standalone performance of the device (instruments and adaptor set) in conjunction with a navigation system. It's not an algorithm in the AI sense, but rather the functional performance of the hardware. The simulated use evaluation specifically describes the device, when manually calibrated with the Medtronic StealthStation navigation system, being used to prepare holes and insert screws, and the final screw position was compared to a post-operative scan and sawbones model. This assesses the system's ability to guide the surgeon accurately.

7. The Type of Ground Truth Used

• Accuracy Verification: The ground truth for accuracy (positional, angular, length) would likely be based on engineering specifications, calibrated measurement devices, or a statistically reliable "true" value derived from multiple precise measurements.
• Simulated Use Evaluation: The ground truth for the simulated use was based on:
  • The "final screw position in the software" (from the Medtronic StealthStation navigation system).
  • Comparison with a "post-operative scan" of the sawbones model.
  • Comparison with the "sawbones model" itself.
    This implies a comparison against the intended surgical plan or ideal placement within the physical model.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments and an adaptor, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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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 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 AQrate™ Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument guide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instrument guides are designed for use with the Medronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The system is indicated for the placement of spinal screws.

The AQrate™ Robotic Assistance System is a medical robotic system with a robotic arm fixed to a mobile cart, hardware, and software. The system allows for accurate positioning of surqical instruments and screws during spinal surgery with the use of a robotic arm. The instruments may be navigated or tracked relative to the patient's anatomy on reconstructed images using the Medtronic StealthStation® System.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the AQrate Robotic Assistance System, which confirms its substantial equivalence to predicate devices based on technological characteristics, performance, and intended use.

While it mentions "Performance Testing" including "Non-clinical system, software, and instrument verification" and "Surgical simulations conducted on phantom models," it does not provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for any test set or data provenance.
3. Number and qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study details or effect sizes.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing ground truth for the training set.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which:

• use of the VIPER System is indicated,
• use of stereotactic surgery may be appropriate, and
• where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.

These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.

The VIPER PRIME™ navigated inserter is a reusable manual screwdriver for insertion of the VIPER PRIME screws of the VIPER System in open and percutaneous procedures. The VIPER PRIME navigated inserter also features attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter must be manually calibrated with the third-party navigation system.

This document is not about an AI/ML powered device, but rather a navigated inserter for spinal surgery. Therefore, the questions related to AI/ML specific concepts like training sets, ground truth establishment for training, MRMC studies, and effect size of human reader improvement with AI assistance are not applicable.

However, I can extract information related to the device's acceptance criteria and the study proving it meets these criteria based on the provided text.

Based on the provided text for the VIPER PRIME navigated inserter, the primary method for demonstrating acceptable performance is through non-clinical sawbones testing. The document does not provide a formal table of acceptance criteria with specific numerical thresholds, nor does it detail a comparative study with a "reported device performance" against explicit criteria beyond general confirmation of function.

Here's an attempt to answer the questions based on the available information:

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

The document does not provide a formal table with quantitative acceptance criteria and corresponding reported performance metrics. Instead, the performance evaluation is described qualitatively as "confirm[ing] device performance for the intended use."

The study confirmed the following functions:

• Acceptance Criteria (Implicit): The device should successfully allow for:
  • Assembly with third-party universal tracking arrays.
  • Manual calibration with the third-party navigation system.
  • Navigated insertion of VIPER PRIME screws in a sawbones model.
  • Final screw position in the software should be verifiable by a second imaging modality.
• Reported Device Performance (Qualitative): The non-clinical sawbones testing "confirmed device performance for the intended use" by demonstrating successful assembly, manual calibration, and navigated insertion of screws, with verification of screw position using a second imaging modality.

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

• Sample Size: The document only states "non-clinical sawbones testing" and "insertion of VIPER PRIME screws in a sawbones model." It does not specify the number of sawbones models used, the number of screws inserted, or the number of trials performed.
• Data Provenance:
  • Country of Origin: Not specified, but given the submission is to the FDA in the USA, the testing would likely adhere to US regulatory standards.
  • Retrospective or Prospective: This was likely a prospective study designed to demonstrate performance for regulatory submission.

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

• The document does not mention the use of human experts to establish "ground truth" for the test set in the way one might for an AI/ML diagnostic device (e.g., radiologist reads).
• The ground truth in this context appears to be the physical confirmation of the screw's final position via a second imaging modality. It is implied that the test was performed by qualified individuals, but their specific roles or qualifications (e.g., orthopedic surgeons, engineers) are not detailed.

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

• Not applicable in the context of this device. There is no mention of consensus reading or multi-reader adjudication for establishing ground truth, as the "ground truth" is the physical location of the screw confirmed by imaging.

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

• Not applicable. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with/without AI assistance was not performed.

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

• Not applicable. This is a hardware device requiring human interaction and navigation system input. There is no standalone algorithm to evaluate.

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

• The ground truth was established by physical verification of the final screw position using a second imaging modality after insertion in a sawbones model. This is a form of objective measurement/outcomes data within the controlled test environment.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. There is no training set for this device.

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The SYMBIS Surgical System is a computer-controlled electromechanical arm. The arm is performed by the neurosurgeon. It is intended to be used in the spatial positioning and orientation of a biopsy instrument guide.

Guidance is based on a pre-operative plan developed using the Medtronic StealthStation® along with fiducial marker or optical registration. The system is intended for use by neurosurgeons to guide a biopsy needle.

It is intended for use by trained physicians for needle based biopsy.

The SYMBIS Surgical System is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument guide. The system is intended for use by trained physicians for needle based biopsy.

The SYMBIS Surgical System consists of the a Surgeon Console, Surgical Cart, Manipulator, Robot Control Cabinet (RCC), Vision System, Platform Room Integration Kit and System Software.

The Manipulator is a master/slave robot configured with either a left arm or a right arm is mounted to the Surgical Cart. The Surgical Cart is used to transport the Manipulator to and from the operating room, as well as serve as a stationary platform for robotic surgery. The Surgical Cart has an onboard immobilization system to prevent horizontal movement when positioned for surgery. The Instrument Guide is attached to the draped Manipulator and is used by the surgeon to guide the trajectory of a stereotactic instrument (e.g. Biopsy Needle). The Manipulator has six (6) degrees of freedom (DOF). The SYMBIS System provides tremor filtering and motion scaling while the surgeon positions the Manipulator and Instrument Guide to the target position. A Vision System mounted to the Surgical Cart provides the surgeon with a high definition, three-dimensional view of the patient, surgical site, and Manipulator.

The Surgeon Console provides the surgeon with workstation console from which the surgeon controls the Manipulator. The Surgeon Console is located in the operating room. The surgeon, seated at the Surgeon Console, controls all movements of the Manipulator with a hand controller and foot pedal. The upper and middle displays on the Surgeon Console are medical grade, high definition monitors, and the middle monitor is capable of displaying 3 dimensional (3D) images The upper display provides the video output from a third-party navigation system (i.e. Medtronic Stealth station s7/i7). The middle display provides the 3D video output from the field camera, to provide situational awareness to the surgeon when moving the robot near the patient, surgical site, and OR staff. The video from the Vision System, along with the video from the third-party navigation system, is used by the surgeon to manipulate the Instrument Guide to the entry position.

The Robot Control Cabinet (RCC) is an electronics rack and contains to operate the Surgical Cart, Manipulator and Surgeon Console. It is situated in the hospital's equipment room, adjacent to the surgical suite. The RCC includes the supporting electronic, power supply, and computers for the system.

The platform room integration kit includes motor drivers to run the Manipulator, an OR Pendant with an E-Stop, cable interface mounting plates and system integration cables.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for SYMBIS Surgical System

1. Table of Acceptance Criteria and Reported Device Performance

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