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The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures.

Their use 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 the spine or pelvis, can be identified relative to a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:

• Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
• Posterior Screw Placement in C3-C7 vertebrae
• Iliosacral Screw Placement
• Angular procedures requiring access to the disc space
• Lateral trajectories required to access the Sacro-Iliac joint

The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

This special 510(k) submission outlines minor software modifications to the cleared XVS system, aimed at enhancing the 2D-3D registration process. Changes include minor updates to the C-ARM Ring adaptor, XVS sterile kits with C- and X-markers, and the addition of a patient marker extender for improved reflectors' visibility. A new software version introduces enhancements to the GUI, ease of use, and bug fixes.

The provided text is a 510(k) summary for the Augmedics xvision Spine system, a medical device with minor modifications. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not a de novo clearance that would typically involve extensive clinical trials to establish new performance criteria. Therefore, the information provided primarily addresses hardware and software modifications and their impact on existing performance, rather than defining and proving novel acceptance criteria for a new device.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria for specific performance metrics of the AI/software component, as it's a minor modification submission. However, it explicitly states:

• Acceptance Criteria Mentioned:

  • "System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2°" (This is an identical characteristic to the predicate device and is stated as a requirement for both).
  • Performance tests verified that mechanical stability of the attachment of the new component, overall system accuracy and compliance with existing sterilization, cleaning and transportation standards is maintained.

• Reported Device Performance (for the modified system):

  • "Performance tests verified that mechanical stability of the attachment of the new component... is maintained."
  • "the overall system accuracy, including positional and angular accuracy during 2D/3D registration, was validated successfully using the same methods and acceptance criteria [as the predicate device]."
  • "Performance data (bench), demonstrate that the modified parts meet the same acceptance criteria as the cleared parts and that the accuracy performance of the modified XVS system is comparable to the accuracy results of the predicate device."

Summary Table (Derived from the text):

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

The document states, "Performance data (bench)", indicating the tests were conducted in a laboratory or simulated environment rather than with patient data. It does not provide specific sample sizes (e.g., number of models, number of trials) for these bench tests. The provenance is implied to be from Augmedics' internal testing in Israel (based on the submitter's address), and the data are likely prospective in nature as they concern verifying changes to a device.

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

This information is not provided. Since the performance evaluations appear to be bench tests against engineering specifications (e.g., positional and angular accuracy), it's unlikely that clinical expert ground truth was established for this specific submission. The ground truth for the core device's accuracy would have been established during the original clearance (K241481), but details are not included here for this modification.

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

Not applicable based on the information provided. The evaluations are described as "bench tests" and "performance data (bench)", implying quantitative measurements against engineering tolerances rather than subjective assessments 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 such study was mentioned. The device is an image-guided navigation system for surgery, not an AI diagnostic tool that assists human readers/interpreters in a diagnostic task. The AI component mentioned is for "Deep-Learning Based Spine Segmentation Algorithms," which aids in preparing the surgical navigation data, not interpreting images for diagnosis. The modifications relate to hardware components and software enhancements for workflow and reliability, not changes to the core AI segmentation algorithms requiring a new MRMC study.

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

The document mentions "Deep-Learning Based Spine Segmentation Algorithms" as an identical characteristic to the predicate. It also states "the overall system accuracy, including positional and angular accuracy during 2D/3D registration, was validated successfully using the same methods and acceptance criteria." While this suggests evaluation of the system's accuracy (which would include the algorithm's contribution), it doesn't describe a standalone algorithm-only performance study in isolation from the full system's operation, nor does it provide detailed metrics for such a study. The focus is on the integrated system's performance.

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

For the accuracy components, the ground truth would have been derived from precise physical measurements and calibrations in a controlled bench test environment (e.g., using CMM - Coordinate Measuring Machine, as mentioned, or other metrology tools) against known true values. For the segmentation algorithms, the ground truth for training and evaluation would typically be meticulously annotated anatomical structures, likely by medical experts. However, these details are not provided for this submission, as the segmentation algorithms themselves are identified as identical to the predicate.

8. The sample size for the training set

This information is not provided. The deep learning segmentation algorithms are noted as identical to the predicate device, meaning their training would have occurred prior to the predicate's clearance (K241481).

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

This information is not provided. As with point 8, this process would have occurred for the predicate device. Typically, for deep learning segmentation in medical imaging, ground truth is established through manual annotation by qualified medical professionals (e.g., radiologists, anatomists, surgeons) following specific guidelines.

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The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures.

Their use 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 the spine or pelvis, can be identified relative to a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:

• Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
• Posterior Screw Placement in C3-C7 vertebrae
• Iliosacral Screw Placement
• Angular procedures requiring access to the disc space
• Lateral trajectories required to access the Sacro-Iliac joint

The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The xvision Spine System (XVS) is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery by displaying stereoscopic augmented reality (AR) navigation onto the patient anatomy. The system consists of dedicated software running on a PC, a headset, single use passive reflective markers, and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired patient's scan, onto the surgical field. The 2D data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

The purpose of this 510(k) submission is to introduce a new registration algorithm that enables registering a 3D CT scan that was acquired prior to surgery (pre-operative CT) using 2D X-ray images, taken intra-operatively with a C-Arm. As part of the development of this registration method, the company developed a new software algorithm that includes a deep learning-based spine segmentation algorithm that segments individual vertebrae including the sacrum and ilium. The segmentation output is used as an input to the new registration algorithm.

The indications for use of the subject device compared to its predicate are expanded and include the use of patient's X-ray images for registration and support of angular and lateral procedures requiring access to the disc space and sacro-iliac joint. These modifications do not alter the intended purpose of the system as an aid in localization of anatomical structures during spine surgery or its principles of operation, it just enables additional inputs for registration and supports navigation in additional traiectories.

Here's a summary of the acceptance criteria and study information for the xvision Spine System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Registration Accuracy and Overall System Accuracy (Phantom Tests): Tests were performed using "phantoms" under different scenarios simulating clinical conditions. The exact number of phantoms or test cases within these phantom studies is not specified.
• System Accuracy (Cadaver Studies): Three cadaver studies were conducted. The number of individual screws positioned or specific cadaver count is not specified, but it covered sacro-iliac, sacro-lumbar, thoracic, and C3-C7 vertebrae levels.
• Segmentation Algorithm Validation: "A set of CT scans" was used for validation. The exact number of CT scans is not specified.
• Data Provenance: Not explicitly stated for specific datasets. Phantom tests are simulated. Cadaver studies are typically prospective. The CT scans for segmentation validation were reviewed by "US physicians," implying the retrospective or prospective origin of this data could be from US sources, but this is not definite.

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

• Cadaver Studies: Ground truth for positional and trajectory errors was determined by measuring the difference between actual and virtual screw tip positions and orientations. Clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing post-op scans. The number and qualifications of experts involved in this evaluation are not specified.
• Segmentation Algorithm Validation: Ground truth was established by "manual segmentations that were approved by US physicians." The number of physicians and their specific qualifications (e.g., years of experience, specialty) are not specified.

3. Adjudication Method for the Test Set:

• The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For the segmentation algorithm, manual segmentations were "approved by US physicians," which could imply a consensus or review process, but details are not provided.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned in the provided text. The study focuses on the device's standalone performance and its comparison to its predicate.

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

• Yes, a standalone performance evaluation was done for the segmentation algorithm. Its performance was validated against manual segmentations.
• The system-level accuracy and registration accuracy were also evaluated as standalone (device-only) performance, using phantoms and cadavers, measuring inherent accuracy rather than human-AI interaction.

6. The Type of Ground Truth Used:

• Cadaver Studies:
  • Positional and Trajectory Errors: Based on measurements of actual vs. virtual screw tip positions and orientations. This is an objective, measured ground truth.
  • Clinical Accuracy: Evaluated using the Gertzbein-Robbins score by viewing post-op scans. This relies on expert assessment of imaging.
• Segmentation Algorithm Validation: Expert consensus/manual annotation, as it was compared with "manual segmentations that were approved by US physicians."

7. The Sample Size for the Training Set:

• The document does not specify the sample size for the training set used for the deep learning-based spine segmentation algorithm.

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

• The document does not specify how the ground truth for the training set was established for the deep learning-based spine segmentation algorithm. It only mentions that the validation of the algorithm was done by comparing it with manual segmentations approved by US physicians.

Ask a specific question about this device

The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use 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 the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the following spinal implant procedures:

• Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
• Posterior Screw Placement in C3-C7 vertebrae
• Iliosacral Screw Placement

The Headset of the xvision System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

The following modifications have been applied to the previously cleared XVS system:

The indications for use of the subject device are expanded compared to the cleared predicate device and include screw instrumentation in additional spine segments, i.e., cervical C3-C7 vertebrae and iliosacral region. Additionally, an Artificial Intelligence (AI) spine segmentation algorithm, based on Convolutional Neural Network (CNN), has been added to provide an improved virtual 3D spine model. The virtual 3D model can be built from the original CT scan or from the Al segmented CT scan. Neither of these modifications alters the intended use of the device as an aid in localization during spine surgery or its principles of operation.

Here's a breakdown of the acceptance criteria and study details for the xvision Spine System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides the "System Accuracy Requirement" as the primary acceptance criterion related to performance. The study then reports on validation studies that demonstrate the device meets these specifications.

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

• Test Set Sample Size: Two cadaver studies were conducted. The specific number of cases, screws, or segments tested within these cadaver studies is not explicitly stated in the provided document.
• Data Provenance: The document states "two cadaver studies." This suggests the data is prospective (generated for this specific testing) and likely from a laboratory or research setting. The country of origin of the cadavers or the study location is not specified.

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

• For the cadaver studies (positional and trajectory errors), the method of establishing ground truth (e.g., through physical measurements) is implied by "actual... screw tip position" and "actual... screw orientation" but the number or qualifications of experts involved in these measurements are not specified.
• For the AI segmentation algorithm validation: "manual segmentations that were approved by US physicians" were used as ground truth. The number of physicians/experts and their specific qualifications (e.g., years of experience as radiologists or surgeons) are not specified.

4. Adjudication Method for the Test Set

• For the cadaver studies, no adjudication method is described. Measurements for positional and trajectory errors are typically objective and can be directly measured.
• For the AI segmentation validation, the manual segmentations were "approved by US physicians." This suggests a consensus or review process, but the specific adjudication method (e.g., 2+1, 3+1) is not detailed.

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

• The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how human readers improve with AI vs. without AI assistance. The AI component is described as providing an "improved virtual 3D spine model" but its impact on human reader performance is not measured in this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance evaluation was conducted for the AI segmentation algorithm. The "mean Dice coefficient was calculated" to measure the quality of the algorithm's segmentation compared to manual ground truth. This is a common metric for evaluating the performance of segmentation algorithms independently.

7. The Type of Ground Truth Used

• For system accuracy (positional/trajectory errors): The ground truth was based on physical measurements of actual screw tip position and orientation in cadavers.
• For AI segmentation algorithm: The ground truth was established by manual segmentations approved by US physicians.

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set used for the Convolutional Neural Network (CNN) based AI spine segmentation algorithm. It only mentions that the algorithm has been "added to provide an improved virtual 3D spine model."

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

• The document does not explicitly state how the ground truth for the training set of the AI algorithm was established. While it mentions manual segmentations by US physicians for the validation set, it does not detail the process for the training data. It's common practice for training data ground truth to also be established by expert annotation, but this is not explicitly confirmed in the provided text.

Ask a specific question about this device

The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use 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 the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and traiectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Mean positional error: 2.32mm (99% UBL= 2.58mm)
• Mean angular error: 1.66° (99% UBL=1.93°)
  Statistically significantly lower than 3mm positional and 3 degrees angular error. |
  | Clinical accuracy for pedicle screw placement in sacral/lumbar vertebrae (Gertzbein score) | A total accuracy of 97.7% demonstrated.
  Very similar to the literature control rate of 95%. |
  | Electrical safety | Tested in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012. Successfully completed. |
  | Electromagnetic Compatibility (EMC) | Tested in accordance with IEC 60601-1-2:2014. Successfully completed. |
  | Sterilization validation for single-use components | Conducted in accordance with ANSI AAMI ISO 11137-1:2006/(R)2015. Shelf life and packaging testing performed. All tests successfully completed. |
  | Cleaning and steam sterilization validation for reusable components | Cleaning: AAMI TIR30:2011. Steam sterilization: ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013. Successfully completed. |
  | Biocompatibility of patient contact materials | Verified according to ISO 10993-1:2018 and FDA guidance on the use of ISO 10993-1, June 16, 2016. All tests successfully completed. |
  | Software verification and validation | Conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002. |

Note: While the reported positional error (2.32mm) is higher than the stated acceptance criteria (2.0mm), the text explicitly states it's "statistically significantly lower than 3mm," which implies it met a broader acceptable threshold or was deemed clinically acceptable despite exceeding the initial numerical target slightly.

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

• Cadaver Study (Accuracy): The sample size for the cadaver study is not explicitly stated as a number of cadavers or individual pedicle screws. It generically mentions "pedicle screws were positioned percutaneously in thoracic and sacro-lumbar vertebrae."
  • Provenance: This was an ex-vivo study (cadaver study), implying it likely occurred in a controlled lab environment. No specific country of origin is mentioned, but the submitter is based in Israel.
• Clinical Study (Clinical Accuracy):
  • Sample Size: Seventeen (17) subjects.
  • Provenance: Prospective, single-arm, multicenter study. No specific country of origin for the clinical sites is provided.

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

• Cadaver Study: The text does not explicitly state the number of experts or their qualifications for establishing ground truth (e.g., measuring actual screw tip positions from post-op scans). This aspect is implicit in the "calculated as the difference between the actual screw tip position... and its virtual tip" description.
• Clinical Study: The ground truth for clinical accuracy was established using the Gertzbein score by "viewing the post-op scans." The number and qualifications of experts (e.g., experienced radiologists, spine surgeons) assessing the Gertzbein score are not specified in the provided text.

4. Adjudication method for the test set:

• The text does not explicitly describe an adjudication method (like 2+1, 3+1) for either the cadaver or the clinical study. It mentions the Gertzbein score being assessed by "viewing the post-op scans," but not how discrepancies among multiple reviewers, if any were used, would be resolved.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies described focus on the standalone performance of the xvision Spine system, not on its impact on human reader performance or a comparison of human readers with and without AI assistance. The device is an image-guided navigation system for surgical procedures, assisting the surgeon directly during the procedure rather than improving pre-operative image interpretation by radiologists.

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

• Yes, standalone performance was evaluated. The "System Level Accuracy" criteria and the results from both the bench testing (phantoms) and the cadaver study directly assess the accuracy of the device itself (positional and angular errors) without human in-the-loop influence on the measurement of accuracy. The clinical study also measures the system's accuracy in a real-world setting using post-operative scans.

7. The type of ground truth used:

• Bench Testing (Phantoms): The ground truth was established by the known mechanical properties and precise measurements within the phantom setup, as well as presumably known parameters for partial detectability scenarios.
• Cadaver Study: Ground truth was established by comparing the device's recorded "virtual tip" and "virtual trajectory" to the "actual screw tip position" and "screw orientation" derived from post-operative imaging scans.
• Clinical Study: Ground truth for clinical accuracy was based on the Gertzbein score obtained from viewing post-operative imaging scans. The Gertzbein score implicitly provides a categorization of screw placement accuracy (e.g., ideal, acceptable, minor breach, major breach).

8. The sample size for the training set:

• The text does not provide any information about the sample size used for the training set of the xvision Spine system's algorithms. It focuses entirely on verification and validation testing.

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

• Since no information about a training set is provided, there is no information on how its ground truth was established.

Ask a specific question about this device

The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use 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 the spine, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

The provided text describes the performance data and testing conducted for the xvision Spine system, particularly focusing on its accuracy in guiding pedicle screw placement.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criteria for the xvision Spine system relate to its positional and trajectory angle accuracy. The document implicitly sets these criteria by comparing the device's performance to the predicate device and by reporting the mean errors and 99% Upper Bound Limits (UBLs).

Note: The document explicitly states: "Thus, the system has demonstrated performance in 3D positional accuracy with a mean error statistically significantly lower than 3mm and in trajectory angle accuracy with a mean error statistically significantly lower than 3 degrees, in phantom and cadaver studies." However, the "System Accuracy Requirement" for the device, as listed in the comparison table with the predicate, is 2.0mm positional error and 2° trajectory error. The reported performance is compared to this requirement rather than a broader 3mm/3degree standard. Therefore, the "Acceptance Criteria" column above reflects the stricter "System Accuracy Requirement" from the comparison table.

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

• Phantom Study: The sample size for the phantom study is not explicitly stated in terms of the number of measurements or trials. However, it involved testing under "different conditions simulating clinical conditions such as: Headset mounted statically and Headset moving above the markers, different distances between the Headset and the markers, and different angles" and using two Z-link markers (Z1 and Z2).
• Cadaver Study: The sample size is not explicitly stated for the cadaver study either, but it involved positioning pedicle screws percutaneously in "thoracic and sacro-lumbar vertebrae." The number of cadavers or screws tested is not provided.
• Data Provenance:
  • Phantom Study: The data provenance is laboratory bench testing. The country of origin is not specified, but the applicant company is located in Israel (Augmedics Ltd.).
  • Cadaver Study: The data provenance is from a cadaver study. The country of origin is not specified. This would be considered a prospective study as it involves active experimentation.

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

• The document does not specify the number of experts or their qualifications for establishing ground truth in either the phantom or cadaver studies.
• For the cadaver study, the ground truth for positional error was derived from "the post-op scan," and for trajectory error, it was a "recorded planned/virtual trajectory." It implies an objective measurement rather than expert consensus on anatomical landmarks.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test sets. The ground truth appears to be based on direct measurements and pre-defined plans rather than subjective assessments requiring adjudication.

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The studies focused on the accuracy of the device itself (standalone performance and cadaver-assisted performance), not on the improvement in human reader performance with or without AI assistance. The device is a navigation system, assisting surgeons during procedures, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

• Yes, the performance data presented primarily focuses on the standalone performance of the xvision Spine system, particularly its accuracy. The "Bench testing" results demonstrate the algorithm's accuracy in a controlled environment, and the "cadaver study" validates this accuracy in a more realistic anatomical setting, demonstrating the system's ability to guide screw placement. The focus is on the precision of the stereotaxic instrument, not on human interpretation or analysis.

7. Type of Ground Truth Used

• Phantom Study: The ground truth was established through known mechanical positions and precisely defined settings within the phantom, allowing for objective measurement of error from a pre-defined ideal.
• Cadaver Study: The ground truth for positional error was derived from the post-operative scan (objective imaging data), and for trajectory error, it was compared to the recorded planned/virtual trajectory (pre-defined objective plan).

8. Sample Size for the Training Set

• The document does not provide any information regarding a training set or its sample size. This is a medical device for surgical guidance, not a machine learning model that typically requires a separate training set. The descriptions focus on the validation of the system's accuracy and performance.

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

• Since no training set is mentioned or implied for this type of medical device validation, there is no information on how ground truth for a training set was established.

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