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Ask a specific question about this device

OptiVu™ Shoulder is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

OptiVu™ Shoulder utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System. OptiVu™ Shoulder is compatible with any humeral implants that are supported by the Signature ONE™ System.

OptiVu™ Shoulder is specifically indicated for total shoulder arthroplasty using the Zimmer Biomet Alliance® Glenoid system or reverse shoulder arthroplasty using the Comprehensive® Reverse Shoulder system, to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the glenoid component with the anatomical structures.

OptiVu Shoulder includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.

OptiVu Shoulder is a stereotaxic surgical navigation system designed to aid surgeons in locating anatomical structures and aligning the endoprosthesis in total or reverse shoulder arthroplasty procedures. The system includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and mixed reality trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure.

The OptiVu Shoulder system is intended to be used specifically with the Zimmer Biomet Alliance® Glenoid or Comprehensive® Reverse Shoulder system for total or reverse shoulder arthroplasty, respectively.

The OptiVu Shoulder system also utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System.

The intended users of the system are surgeons who are trained in performing shoulder arthroplasty procedures.

This 510(k) clearance letter pertains to a Special 510(k) submission for the OptiVu™ Shoulder system. A Special 510(k) is used when changes to a previously cleared device do not alter its fundamental scientific technology or indications for use, but rather involve specific modifications. In this case, the modifications are explicitly stated to be updates to packaging parameters and the site for contract sterilization, not changes to the software, functionality, or performance of the navigation system itself.

Therefore, the provided document does not contain the information requested about the acceptance criteria and study proving the device meets those criteria for the AI/software performance, as this type of study would have been part of the original 510(k) clearance for OptiVu™ Shoulder (K250108), not this Special 510(k) (K252170). The validation testing performed for this submission is limited to sterilization efficacy and packaging safety.

This document explicitly states:

• "The purpose of this Special 510(k) submission is to update both the packaging parameters for the instruments and the site for contract sterilization."
• "There are no differences in technological characteristics that raise questions of safety and efficacy."
• "With the updated packaging and sterilization parameters presented in this submission, there are no technological or design changes in the subcomponents of the OptiVu Shoulder system instruments themselves."
• "Validation testing was conducted according to written protocols with acceptance criteria that were based on established standards. This submission includes or references the following tests in support of a substantial equivalence determination:
  • Sterilization validation testing to confirm that there is no impact to the sterilization efficacy of the system
  • Packaging validation to confirm that the packaging of OptiVu Shoulder system is safe and effective"

Conclusion based on the provided document:

The provided 510(k) clearance letter for K252170 (OptiVu™ Shoulder) is a Special 510(k), which addresses changes only to the packaging and sterilization of the device, not its core functionality or software performance. As such, the document does not contain any information about acceptance criteria or performance studies related to the artificial intelligence/software accuracy, clinical effectiveness, human reader improvement with AI assistance, or the establishment of ground truth for such studies. This type of information would have been part of the original 510(k) submission (K250108) for the device's fundamental technology.

Therefore, I cannot populate the requested table or answer the specific questions about AI/software performance, ground truth, and study parameters based solely on the provided text.

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The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:

• Pedicle Screw Placement (Thoracic and Lumbosacral spine)
• Sacro-Iliac Screw Placement

NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.

The NextAR Spine platform is intended to be used in combination with NextAR™ Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning, surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

NextAR Spine sterile drill and pins

The sterile drills, pins and iliac pins are part of the NextAR Spine platform which is intended as an aid for precisely locating anatomical structures in either open / mini open or percutaneous spine procedures. The NextAR Spine sterile drills pins and iliac pins are intended for use with the NextAR Spine platform according to its approved indications for use. All the drills are motorized. Pins may be used either motorized or manually. Iliac pins are manual.

The NextAR™ Spine platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

• Navigation software which displays information to the surgeon
• Augmented Reality glasses
• Optical tracking system
• PC based hardware platform
• Fiducial Block
• Surgical instruments for spine surgery procedures

The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.

NextAR™ Spine aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The platform uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D scan in order to register the spine to navigation elements. The registration can be performed with one of the following approaches: 1) Direct 3D: based on the use of an intra-operative 3D scan, or 2) 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan.

Where the Direct 3D approach is utilized, NextAR™ Spine allows for planning of screw positioning on the patient's intraoperative DICOM images just before system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.

The NextAR™ Spine platform also includes the rod planning tool, which gives the surgeon information about the length and the rod type to best fit the spine anatomy and to perform the desired curvature correction.

The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

The FDA 510(k) clearance letter for NextAR™ Spine (K250477) provides limited details on a comprehensive study proving acceptance criteria. However, based on the provided text, we can infer some aspects of the performance data and the methods used to demonstrate the device's substantial equivalence.

Here's an attempt to structure the information based on your request, highlighting what is explicitly stated and what can be inferred or is missing from this document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list acceptance criteria in a quantitative table format nor does it provide numerical performance metrics. Instead, it relies on comparative evaluations and qualitative assessments to demonstrate substantial equivalence to predicate devices. The "Performance Data" section primarily focuses on non-clinical studies.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of cases or subjects. "Cadaver workshops" imply surgical procedures performed on anatomical models (cadavers), but the number is not provided.
• Data Provenance: The document does not specify the country of origin for the cadaver studies or the software testing. The studies were non-clinical. The studies were likely prospective in nature, as they were "performed in support of a substantial equivalence determination."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the mention of "Cadaver workshops" suggests that surgeons or other qualified medical professionals would have been involved to assess the adequacy of the instruments and system for surgical use.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. Given that these were "cadaver workshops" to demonstrate adequacy, it's likely qualitative assessments by the participating surgeons, rather than a formal, multi-reader quantitative adjudication process.

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

• MRMC Study: No. The document explicitly states: "No clinical studies were conducted." This indicates that no MRMC study comparing human readers with and without AI assistance was performed. The device, NextAR™ Spine, is a surgical navigation platform, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies for reader performance improvement (e.g., radiologists interpreting images).

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

• Standalone Study: Not explicitly detailed with performance metrics. The "Software testing" and "Comparative evaluations" could be considered forms of standalone assessment of the algorithmic components and instrument performance, but no specific quantitative standalone performance (e.g., accuracy, precision) of the navigation algorithms themselves is provided in this summary. The device's primary function is as a navigation aid where a human surgeon is always in the loop.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • For instrument performance, the ground truth would likely be established through engineering specifications and comparative measurements against predicate instruments.
  • For the cadaver workshops, the ground truth was likely surgical outcomes/adequacy as determined by the participating surgeons in a realistic (cadaveric) surgical environment. This is a form of expert assessment of functional performance. It is not pathology, or clinical outcomes data, as no clinical studies were performed.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The document describes a traditional medical device (navigation system) with software components, not an AI/Machine Learning device that undergoes a train-test split methodology with large datasets for model training. The software functionality and instrument performance are verified through testing and comparative evaluation, not
  ML model training on patient data.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML system requiring a dedicated training set with established ground truth in the typical sense for image interpretation or diagnosis. The "ground truth" for the device's functionality would stem from its design specifications, engineering principles, and the known anatomical relationships it aims to navigate.

In summary, the FDA 510(k) summary for NextAR™ Spine focuses on demonstrating substantial equivalence through non-clinical performance data, primarily through comparative evaluations with predicate devices and cadaveric workshops, rather than extensive clinical studies or AI model performance metrics.

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OptiVu Shoulder is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

OptiVu Shoulder utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System. OptiVu Shoulder is compatible with any humeral implants that are supported by the Signature ONE™ System.

OptiVu Shoulder is specifically indicated for total shoulder arthroplasty using the Zimmer Biomet Alliance® Glenoid system or reverse shoulder arthroplasty using the Comprehensive® Reverse Shoulder system, to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the glenoid component with the anatomical structures.

OptiVu Shoulder includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.

OptiVu Shoulder is a stereotaxic surgical navigation system designed to aid surgeons in locating anatomical structures and aligning the endoprosthesis in total or reverse shoulder arthroplasty procedures. The system includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and mixed reality trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure.

The OptiVu Shoulder system is intended to be used specifically with the Zimmer Biomet Alliance® Glenoid or Comprehensive® Reverse Shoulder system for total or reverse shoulder arthroplasty, respectively.

The OptiVu Shoulder system also utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System.

The intended users of the system are surgeons who are trained in performing shoulder arthroplasty procedures.

The provided FDA 510(k) clearance letter for OptiVu™ Shoulder describes the device and its intended use, but it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specific study that proves the device meets those criteria.

The document states that non-clinical testing was conducted to demonstrate safety and effectiveness, including "Performance tests to ensure the performance of the implemented features and verify related design inputs" and "Validation lab to validate that the OptiVu Shoulder system is safe and effective and performance of the system is acceptable under full simulated use on cadaveric specimens." However, the specific acceptance criteria values and the quantitative results of these tests are not provided in this public clearance letter. This type of detailed performance data is typically found within the full 510(k) submission, which is a confidential document.

Therefore, I cannot populate the table or provide specific values for most of your questions. I can only infer what kind of studies would have been conducted based on the mention of "Validation lab" with "cadaveric specimens" and "Performance tests."

Here's what I can extract and infer from the provided text, along with clear indications of what information is missing:

While the complete details of the acceptance criteria and the specific study proving the device meets them are not fully contained within the provided FDA 510(k) clearance letter, the document does refer to non-clinical testing that was conducted to demonstrate safety and effectiveness.

The clearance letter mentions:

• "Performance tests to ensure the performance of the implemented features and verify related design inputs"
• "Validation lab to validate that the OptiVu Shoulder system is safe and effective and performance of the system is acceptable under full simulated use on cadaveric specimens"

Based on the nature of a stereotaxic surgical navigation system for shoulder arthroplasty, the acceptance criteria would typically revolve around the accuracy and precision of anatomical structure localization, humerus resection, and endoprosthesis alignment. The "Validation lab" study on cadaveric specimens strongly suggests a performance study was conducted to quantify these aspects.

However, the specific numerical acceptance criteria (e.g., target accuracy in mm and degrees) and the quantitative results (reported device performance) are not provided in this public document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria and reported performance values are not present in the provided document. The table below represents typical acceptance criteria for such a device, and the "Reported Device Performance" column cannot be filled with concrete data from this document.

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

• Test Set Sample Size: Not specified in the provided document. The document mentions "full simulated use on cadaveric specimens," implying a test set that included multiple cadaveric specimens, but the exact number is missing.
• Data Provenance: The document explicitly states "cadaveric specimens." The geographic origin (country) is not specified. The study was likely prospective as it involved simulated use of the device for testing purposes.

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

• Number of Experts: Not specified in the provided document.
• Qualifications of Experts: Not specified in the provided document. For a device used in surgical navigation, these would typically be experienced orthopedic surgeons familiar with shoulder arthroplasty.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified in the provided document. Given the nature of a cadaveric study for surgical navigation accuracy, adjudication might refer to the method used to establish the "true" surgical plan or the "true" anatomical alignment against which the device performance is measured (e.g., independent measurements by a metrology expert, or consensus among multiple surgeons on the optimal plan).

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was NOT mentioned or described in the provided document. This type of study typically assesses the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). OptiVu™ Shoulder is a surgical navigation system with an Augmented Reality (AR) HMD for real-time guidance, not primarily an image interpretation AI tool. Its effectiveness study would focus on its guidance accuracy during simulated surgery, rather than assisting human readers in diagnostic interpretation.
• Effect Size of Human Reader Improvement: Not applicable, as an MRMC study was not described.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: The document describes "Performance tests" and "Validation lab" studies. While the results are not quantified, these studies would inherently evaluate the "standalone" or "algorithm-only" performance of the navigation system (e.g., its accuracy in tracking, registration, and guidance output) in a controlled environment without active human intervention beyond operating the system as intended. The "HMD should not be relied upon solely and should always be used in conjunction with traditional methods" indicates that the device is intended for human-in-the-loop use, but its core performance metrics (accuracy of localization, resection, alignment) would be evaluated in a standalone manner.

7. Type of Ground Truth Used

• Type of Ground Truth: The document explicitly states "full simulated use on cadaveric specimens." Therefore, the ground truth would likely be established through:
  • Pre-operative CT scan planning: The "true" surgical plan (e.g., desired resection angles, implant position) is derived from the pre-operative CT scan using the Zimmer CAS Signature ONE™ System.
  • Post-hoc metrology/physical measurements: After using the OptiVu™ Shoulder system on the cadaver, the actual resections and implant placements would be measured using highly accurate metrology tools (e.g., CMM, industrial CT scanning) and compared against the planned values derived from the pre-operative CT. This comparison would quantify the accuracy of the device's guidance.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified in the provided document. The 510(k) clearance process primarily focuses on the safety and effectiveness of the final device, including its performance characteristics, rather than the details of the training data used for its development (unless it's a specific AI/ML medical device where the training data directly impacts performance).

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

• Training Set Ground Truth Establishment: Not specified in the provided document. As mentioned above, the details of the training process and data are typically not disclosed in the public 510(k) clearance letter.

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ExcelsiusXR™, when used in conjunction with ExcelsiusHub™ and/or ExcelsiusGPS®, is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. This system is indicated for the placement of spinal and orthopedic (Sacroiliac, Ulna, and Tibia) bone screws, and interbody fusion devices.

The ExcelsiusXR™ Headset displays 2D stereotactic images and 3D virtual anatomy images, and displays the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. This headset should not be relied upon solely for absolute positional information and should always be used in conjunction with the primary stereotactic display.

ExcelsiusXR™ is a head-mounted navigation device, or headset, that is used in conjunction with ExcelsiusHub, and ExcelsiusGPS if robotic guidance is desired, as an aid for precisely locating anatomical structures in open or percutaneous procedures, and for precisely positioning compatible surgical instruments or implants (screws and interbody devices) during surgery. ExcelsiusXR™ includes hardware and software that enables real-time surgical visualization using radiological patient images (preoperative CT, intraoperative CT, and fluoroscopy), provides tracking and planning capabilities for a series of compatible instruments, and contains hand tracking cameras for manipulation of the head-mounted display by the user. The Headset displays 2D stereotactic images and provides a 3D visual, or virtual image, of the patient anatomy in the lower region. The 2D data and 3D model, along with tracking information, are projected to the surgeon's retina from the transparent near-eye-display Headset, allowing the surgeon to look at the patient and the navigation data at the same time.

The provided FDA 510(k) Clearance Letter for ExcelsiusXR™ describes performance testing in a general manner but does not contain the specific details required to fully address all parts of your request for acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with numerical acceptance criteria and corresponding performance metrics. It generally states that "Verification and validation testing were conducted on ExcelsiusXR™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system."

It mentions the types of tests performed:

• Non-clinical system, software, and instrument verification and validation – demonstrated compliance with user needs and corresponding design inputs
• Surgical simulations conducted on phantom models
• Qualitative and quantitative validation to confirm intended use and accuracy
• Optical bench testing to evaluate the image quality characteristics of the head mounted display
• Electrical Safety and Electromagnetic Compatibility (compliance with standards)
• Software Verification and Validation Testing (compliance with FDA guidance)

Without specific numeric thresholds or results, a detailed table cannot be created. However, generally, for a navigation system like this, key performance metrics and their associated acceptance criteria would typically include:

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

• Sample Size: The document does not specify the sample size used for any of the performance tests (e.g., number of phantom models, number of tests, number of unique cases).
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. Phantom studies are typically prospective tests under controlled lab conditions.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used to establish ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience").
• Given that "surgical simulations conducted on phantom models" were performed, the "ground truth" would likely be established by the physical measurements taken from the phantom and the known ideal trajectory/placement, often assessed by engineers and potentially verified by clinically experienced personnel.

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating performance. This is generally more relevant for studies involving human interpretation of medical images. For phantom studies, ground truth is typically precisely measured rather than adjudicated in the same way.

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

• The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• There is no information provided on the effect size of how much human readers improve with AI vs. without AI assistance. This type of study would typically be done if the device were primarily an AI-driven diagnostic or interpretative tool, which this navigation system is not. Its primary function is to aid surgical guidance.

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

• The document describes the device as "an aid for precisely locating anatomical structures to be used by surgeons for navigating and/or guiding compatible surgical instruments." It also states "This headset should not be relied upon solely for absolute positional information and should always be used in conjunction with the primary stereotactic display."
• This strongly indicates that the device is intended for human-in-the-loop use, assisting the surgeon.
• While there are "software verification and validation testing" and "surgical simulations on phantom models," these would assess the algorithm's performance within the system context, but the document does not present a standalone, algorithm-only performance metric separate from its intended use as a surgeon's aid. The emphasis is on the system's performance when used by surgeons.

7. Type of Ground Truth Used

• Based on "surgical simulations conducted on phantom models" and "qualitative and quantitative validation," the ground truth was likely established through physical measurements and known anatomical references on the phantom models. This is a form of objective, fabricated ground truth suitable for evaluating a navigation system's precision and accuracy in a controlled environment. It is not expert consensus, pathology, or outcomes data in the traditional sense, though expert surgical opinion would guide the design and interpretation of phantom studies.

8. The Sample Size for the Training Set

• The document does not provide any information regarding the training set size. The FDA 510(k) summary focuses on the "performance testing" (verification and validation), which relates to the test set that demonstrates the device's capabilities post-development. Information about model training (if applicable for any AI components involved in image processing or tracking) is typically not included in such summaries unless it's a primary AI/ML device where the training data directly impacts the cleared function.

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.

In summary, the 510(k) summary provides a high-level overview of the types of performance tests conducted (phantom models, software V&V, electrical safety), but it lacks the detailed quantitative data, sample sizes, and specific methodologies for ground truth establishment that would be found in a full study report. This level of detail is typically contained in the more comprehensive "Basis for Substantial Equivalence" documentation submitted to the FDA, which is not fully replicated in the public 510(k) summary letter.

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Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation Medical Device. The software is intended to display 2D navigation screens as well as a floating 3D virtual representation and stereotactic information of tracked instruments on a virtual display using a Mixed Reality headset. 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 Subject device Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation System. It consists of the software Mixed Reality Spine Navigation 1.0 and the mixed reality headset Magic Leap 2 Medtech (ML2). The software application allows the display in the mixed reality headset of 2D navigation views and a 3D hovering model of the patient anatomy, including stereotactic information of tracked instruments to support the surgeon during pedicle screw placement procedures.

The software Mixed Reality Spine Navigation is installed and running on the Magic Leap 2 MedTech glasses and can only be used in combination with a Brainlab Image Guided Surgery (IGS) platform (Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation Ceiling-Mounted), where the Spine & Trauma Navigation software is running. All required navigation data, such as the patient registration, is transferred over Wi-Fi from the IGS platform to the Magic Leap 2 MedTech. Based on these data, 2D views and a 3D model are rendered by the computing unit of the Magic Leap 2 MedTech and displayed stereoscopically in the headset. Thus, navigation information displayed on the screen(s) of the IGS platform can be simultaneously displayed on Magic Leap 2 MedTech during the surgery.

Magic Leap 2 MedTech is an optical see-through head-mounted display: images are projected on semi-transparent optical layers, giving the surgeons the possibility to have virtual content displayed around the patient while having a view of the real world. If needed, corrective lenses can be attached to the headset.

The provided FDA 510(k) clearance letter and summary for the "Mixed Reality Spine Navigation" device indicates that no clinical testing was required. This suggests that the substantial equivalence determination was primarily based on non-clinical performance data, comparisons to predicate devices, and the established safety and effectiveness of the underlying technology.

Therefore, the request for specific details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance, ground truth establishment, expert adjudication, sample sizes for test/training sets, and MRMC studies, cannot be fully answered using the provided text. The document explicitly states: "No clinical testing was required for the subject device."

However, based on the information provided, we can infer some "acceptance criteria" related to device performance as compared to the predicate, and how the device implicitly meets them through bench testing and verification/validation activities.

Here's an attempt to answer your questions based solely on the provided document, highlighting where information is absent due to the lack of clinical testing:

Acceptance Criteria and Device Performance for Mixed Reality Spine Navigation

The substantial equivalence of the Mixed Reality Spine Navigation device was established primarily through non-clinical testing and comparison to predicate devices, as no clinical testing was required. Therefore, the "acceptance criteria" are implicitly defined by the equivalence to the predicate device's performance characteristics, including accuracy and the successful execution of its intended function in a simulated environment.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of patient data or clinical cases, as no clinical testing was required. Tests were primarily bench tests and usability tests in a simulated environment.
• Data Provenance: The document does not specify data provenance (country of origin, retrospective/prospective) because clinical data was not used for the clearance. Bench test data and simulated environment data would be internal to the manufacturer's testing labs.

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

• Not Applicable / Not Specified: For the required non-clinical testing, "ground truth" would be established by validated measurement systems for accuracy tests (e.g., optical tracking systems for positional/angular accuracy) and adherence to engineering specifications. Usability testing would involve trained personnel simulating surgical use, but the document doesn't specify a number of "experts" to establish ground truth in the sense of clinical reference.

4. Adjudication Method for the Test Set

• Not Applicable: Given the nature of bench testing and simulated environment usability tests, no multi-expert adjudication method (like 2+1, 3+1) would be necessary as it's not a diagnostic AI evaluating medical images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No: The document explicitly states, "No clinical testing was required for the subject device." Therefore, no MRMC study was conducted.

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

• Partial/Indirect: The device is an accessory to a navigation system and displays information to a human user. Its core function relies on the underlying Spine & Trauma Navigation software. The "Navigation accuracy" metrics (positional and angular error) would reflect the algorithmic performance in conjunction with the optical tracking system in a controlled, non-human-in-the-loop setting for those specific measurements. However, the overall device function is human-in-the-loop as it's a navigation display.

7. The Type of Ground Truth Used

• Engineering Specifications and Simulated Performance Metrics: For accuracy, the ground truth would be based on precise measurement systems in a controlled environment to verify the device's ability to display instrument position and orientation within specified tolerances. For usability, the ground truth would be the successful completion of simulated surgical workflows as defined by the manufacturer's design specifications. No "expert consensus," "pathology," or "outcomes data" was used as ground truth for this device clearance.

8. The Sample Size for the Training Set

• Not Applicable: The document does not describe the use of any AI or machine learning models that would require a "training set" in the traditional sense of medical image analysis AI. The device is a mixed reality display system for an existing navigation platform.

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

• Not Applicable: As there's no mention of a "training set" for an AI model, this question is not relevant to the information provided.

In summary: The FDA clearance for "Mixed Reality Spine Navigation" was based on a combination of demonstrating substantial equivalence to a predicate device, comprehensive software verification and validation, hardware verification including safety and biocompatibility, and bench tests validating usability and network performance in a simulated environment. The absence of clinical testing means that acceptance criteria related to clinical efficacy studies, such as those involving human readers, expert ground truth, and patient outcome data, were not part of this specific 510(k) submission.

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The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery.

The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.

Example orthopedic surgical procedures include but are not limited to:

• Total Knee Arthroplasty
• · Unicompartrnental Knee Arthroplasty: Tibial Transverse Resection
• · Hip Arthroplasty

The ARVIS head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.

ARVIS® Surgical Navigation System is a computer-controlled surgical navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.

The subject device is the fundamentally unchanged predicate ARVIS® Surgical Navigation System. It is indicated for use in knee and hip arthroplasties. ARVIS® Surgical Navigation System combines software, electronic hardware and surgical instruments to intraoperatively track tools and locate anatomical structures based on the patient's preoperative imaging.

The navigation platform is identical to the predicate and uses the same electronic hardware, mounted on the surgeon's head and waist.

The subject device adds the capability to remotely activate graphical user interface (GUI) buttons and check boxes for the surgeon, who optionally can use this to work in conjunction with the current methods of gaze and voice control. The added capability is intended to provide a third alternate option for the surgeon to interact with the software.

ARVIS® Surqical Navigation System displays measurements as described in Performance Claims.

The provided text does not contain information about the acceptance criteria or a study proving that a new device meets such criteria. Instead, it describes a medical device submission (K243980) for the ARVIS Surgical Navigation System, which is stated to be "the fundamentally unchanged predicate ARVIS® Surgical Navigation System."

The key takeaway is that this submission is for a device that is essentially the same as a previously cleared device (K203115), with only a minor technological difference: the addition of a remote activation capability for GUI buttons and checkboxes via a tablet device.

Therefore, the document explicitly states:

• "Clinical testing was not required to demonstrate substantial equivalence."
• "The performance data provided in this submission demonstrate that ARVIS® Surgical Navigation System is as safe, effective, and performs as well as the predicate device."

Since this is a submission for a device that is largely identical to a predicate device, the typical extensive studies to establish acceptance criteria and prove performance for a new device are not detailed here. The submission relies on the established safety and effectiveness of the predicate device and verification/validation for the minor change.

Consequently, I cannot fill out the requested information regarding acceptance criteria, sample size, expert ground truth establishment, MRMC studies, or standalone performance for a new device's proving study, as such studies are not described in this document for K243980.

The document only mentions:

• Non-Clinical Tests: Software Verification and Validation.
• Conclusion: The device changes were verified and validated with existing well-established methods, demonstrating substantial equivalence to the previously cleared ARVIS Surgical Navigation System (K203115).

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Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.

Knee+ is a navigation system dedicated to orthopaedic kneePlus software and KneeTools reusable surgical instruments.

The main purpose of Knee+ is to assist the surgeon during primary Total Knee Arthroplasty (TKA) interventions.

Knee+ provides information to help locate and orientate the main femoral and tibial cutting planes as required during TKA. Knee+ allows the surgeon to adjust the orientation of the cutting plane orientation and the level of resection by collecting anatomical references during the TKA procedure using surgical instruments. The software frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation and location of the tracked cutting guide. Knee+ software is installed on a wearable Head Mounted Device (HMD) which includes a camera, a computer and displays intraoperative information to the user. A near-eye display allows the HMD screen when needed.

The provided document [K243975](https://510k.innolitics.com/search/K243975) is a 510(k) Premarket Notification from Pixee Medical for their device, Knee+. This document claims substantial equivalence to a previously cleared version of the same device (K233899). As such, it does not detail a new study proving the device meets new acceptance criteria, but rather demonstrates that modifications to the device do not negatively impact its performance or raise new safety/effectiveness concerns, maintaining the performance established by the predicate.

Therefore, much of the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of a new clinical study for FDA clearance is not present, as this is a 510(k) submission showing substantial equivalence of a modified device.

However, based on the non-clinical testing summaries provided, I can infer and construct answers to some of your questions relevant to the performance demonstration for the modified device in comparison to the predicate, and how its established performance was maintained.

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

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

The document states: "Precision and accuracy of the device remain unchanged compared to previous version when measured according to the same methods." It also mentions "Bench testing was conducted in order to demonstrate that Knee+ performs according to its requirements and specifications. In particular, repeatability and accuracy were tested according to ASTM F2554."

Since this is a 510(k) for a modified device, the "acceptance criteria" would primarily be maintaining the performance established by the predicate. Explicit numerical acceptance criteria and reported device performance for these specific modifications are not provided in this public summary. However, the statement "All performance testing demonstrates that Knee+ performs according to its specifications and functions as intended" implies that the device met internal specifications.

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

The document does not specify test set sample sizes for the non-clinical bench testing (e.g., how many measurements were taken for repeatability and accuracy). It primarily relies on bench testing and human factors testing.

• Non-Clinical Testing Providence: France (Pixee Medical is based in Besançon, France). The testing performed is described as "Bench testing" and "Human factors." These are typically prospective tests.
• Clinical Data: "Clinical testing is not applicable." This indicates no new clinical studies were conducted for this 510(k) submission as the device is substantially equivalent to its predicate.

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

Not applicable for this 510(k) as the submission primarily relies on non-clinical bench testing and human factors assessment, not on a new clinical study requiring ground truth established by medical experts for performance evaluation.

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

Not applicable. As this is a 510(k) submission based on substantial equivalence, there's no mention of a clinical study that would require adjudication of expert opinions for a test set.

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 was not done. The device is a stereotaxic system for guiding Total Knee Replacement, not a diagnostic AI system requiring reader studies. Clinical testing was deemed "not applicable" for this 510(k).

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

The performance testing described (repeatability and accuracy via ASTM F2554) would be considered a standalone assessment of the device's measurement capabilities. However, this is for the surgical guidance aspect, not an AI algorithm generating a diagnostic output to be evaluated independently in isolation from clinical context. The device is intended to be used with human clinicians: "The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods."

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

For the non-clinical bench testing for accuracy and repeatability, the "ground truth" would be established by the precise measurements of a calibrated reference system or phantom used in the testing (e.g., known distances or angles on a test fixture). This is standard for evaluating the accuracy of navigation or measurement systems.

8. The sample size for the training set

Not applicable. This document is for a medical device (stereotaxic instrument), not a machine learning/AI algorithm that requires a training set in the conventional sense for a diagnostic output. While the device does use "software algorithms" to process collected coordinates, there's no indication of a machine learning model that requires an external training dataset in the context typically discussed for AI/ML-driven medical devices.

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

Not applicable, as there's no mention of a training set for an AI/ML model for which "ground truth" would need to be established in this context.

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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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