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510(k) Data Aggregation
(29 days)
Surgical Theater, Inc.
SpineAR SNAP is intended for use for pre-operative surgical planning on-screen and in a virtual environment, and intraoperative surgical planning and visualization on-screen and in an augment using the HoloLens2 and Magic Leap 1 AR headset displays with validated navigation systems as identified in the device labeling.
SpineAR SNAP is indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy. SpineAR is intended for use in spinal implant procedures, such as Pedicle Screw Placement, in the lumbar and thoracic regions with the Magic Leap 1 and HoloLens2 AR headsets.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.
The SpineAR SNAP does not require any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelf" components that meet minimum performance requirements.
The SpineAR SNAP software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views for viewing on a high-definition (HD) touch screen monitor. The surgeon prepares a pre-operative plan for stereotaxic spine surgery by inserting guidance objects such as directional markers and virtual screws into the 3D scene. Surgical planning tools and functions are available on-screen and when using a virtual reality (VR) headset. The use of a VR headset for preoperative surgical planning further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor.
By interfacing to a 3rd party navigation system such as a Medtronic StealthStation S8, the SpineAR SNAP extracts the navigation data (i.e. tool position and orientation) and presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. Once connected, the surgeon can then execute the plan through the intraoperative use of the SpineAR SNAP's enhanced visualization and guidance tools.
The SpineAR SNAP supports three (3) guidance options from which the surgeon selects the level of guidance that will be shown in the 3D scene. The guidance options are dotted line (indicates deviation distance), orientation line (indicates both distance and angular deviation), and ILS (indicates both distance and angular deviation using crosshairs). Visual color-coded cues indicate alignment of the tracker tip to the guidance object (e.g. green = aligned).
The 3D scene with guidance tools can also be streamed into an AR wireless headset (Magic Leap 1 or HoloLens2) worn by the surgeon during surgery. The 3D scene and guidance shown within the AR headset is projected above the patient and does not obstruct the surgeon's view of the surgical space.
The provided text describes the acceptance criteria and the study conducted to prove that the SpineAR SNAP device meets these criteria, specifically addressing the expansion of its indications for use with the HoloLens2 AR headset to include the thoracic region in addition to the lumbar region.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are presented as "Accuracy Requirement" in the table, and the "HoloLens2 AR Headset Results" are the reported device performance for the subject device.
| Metric | Acceptance Criteria | Reported Device Performance (HoloLens2 AR Headset Results) |
|---|---|---|
| Mean Positional/Displacement Error | ≤ 2.0 mm | 0.76 mm |
| Max Positional/Displacement Error | ≤ 3.0 mm | 1.47 mm |
| Mean Trajectory/Angular Error | ≤ 2° | 1.73° |
| Max Trajectory/Angular Error | ≤ 3° | 2.96° |
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 the exact sample size (number of screws or spine models) used for the test set. It only mentions that the final placement of "each screw in a spine model" was assessed.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the study describes a controlled performance test involving a "spine model," suggesting a prospective, in-vitro (non-human) study designed to evaluate accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the involvement of human experts for establishing the ground truth of the pedicle screw placement in this particular performance study. The ground truth appears to be established through "post-surgical CT scan" data compared to a "pre-surgical plan."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method involving human experts is described for this performance study. The assessment of screw placement was based on quantifiable measurements derived from CT scans.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on the device's accuracy in a non-human, simulated environment (spine model) and compares the HoloLens2 performance to the previously cleared Magic Leap 1. It does not evaluate human reader performance or the improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This study is essentially a standalone (algorithm only) performance assessment, although the device (SpineAR SNAP) is an augmented reality system intended for human use. The performance test specifically evaluates the accuracy of the system's guidance during simulated pedicle screw placement, independent of the surgeon's skill. The "human-in-the-loop" aspect during clinical use is acknowledged, but the performance testing here isolates the device's accuracy in a controlled setup.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was objective quantitative measurements derived from post-surgical CT scans of a spine model, which were then compared against the pre-surgical plan. This is a form of objective physical ground truth.
8. The sample size for the training set
The document does not provide any information about the training set size or methodology. This submission is for a modification to an existing device (expanding indications for an existing AR headset), not the initial development or de novo clearance of the core algorithm.
9. How the ground truth for the training set was established
As no information on a training set is provided, how its ground truth was established is also not detailed. The current study focuses on validation of expanded indications through performance testing only.
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(373 days)
Surgical Theater, Inc.
SpineAR SNAP is intended for use or pre-operative surgical planning on-screen and in a virtual environment, and intraoperative surgical planning and visualization on-screen and in an augment using the HoloLens2 and Magic Leap 1 AR headset displays with validated navigation systems as identified in the device labeling.
SpineAR SNAP is indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy. SpineAR is intended for use in spinal implant procedures, such as Pedicle Screw Placement, in the lumbar and thoracic regions with the Magic Leap 1 AR headset, and in the lumbar region with the HoloLens2 AR headset.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.
The SpineAR SNAP does not require any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelf" components that meet minimum performance requirements.
The SpineAR SNAP software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views for viewing on a high-definition (HD) touch screen monitor. The surgeon prepares a pre-operative plan for stereotaxic spine surgery by inserting guidance objects such as directional markers and virtual screws into the 3D scene. Surgical planning tools and functions are available on-screen and when using a virtual reality (VR) headset. The use of a VR headset for preoperative surgical planning further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor.
By interfacing to a 3rd party navigation system such as a Medtronic StealthStation S8, the SpineAR SNAP extracts the navigation data (i.e. tool position and orientation) and presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. Once connected, the surgeon can then execute the plan through the intraoperative use of the SpineAR SNAP's enhanced visualization and guidance tools.
The SpineAR SNAP supports three (3) guidance options from which the surgeon selects the level of guidance that will be shown in the 3D scene. The guidance options are dotted line (indicates deviation distance), orientation line (indicates both distance and angular deviation), and ILS (indicates both distance and angular deviation using crosshairs). Visual color-coded cues indicate alignment of the tracker tip to the guidance object (e.g. green = aligned).
The 3D scene with guidance tools can also be streamed into an AR wireless headset (Magic Leap 1 or HoloLens2) worn by the surgeon during surgery. The 3D scene and guidance shown within the AR headset is projected above the patient and does not obstruct the surgeons view of the surgical space.
The provided text describes the SpineAR SNAP device and its performance data to establish substantial equivalence for FDA 510(k) clearance. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "System Accuracy Requirements" section and the "Performance Data" section.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Navigation Accuracy | 3D Positional Accuracy: |
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(45 days)
Surgical Theater, Inc.
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis.
The SRP BrainStorm software has the ability of creating 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor. The use of a virtual reality (VR) or augmented reality (AR) headset provides the surgeon a 3D stereoscopic display of the same scene inside the VR / AR headset. While wearing the VR / AR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out. The use of the SuRgical Planner (SRP) BrainStorm with VR / AR headset and controllers is not intended for use during surgery. The SRP BrainStorm is intended for use for pre-operative planning.
The SRP BrainStorm software includes additional features to facilitate the review of relevant data by a multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning.
The SRP BrainStorm product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelt" components that meet minimum performance requirements. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
This 510(k) premarket notification describes a software device, SuRgical Planner (SRP) BrainStorm, which is intended for use as a software interface and image segmentation system for the transfer of image information from medical scanners to an output file. It is also used for pre-operative planning and surgical training in a virtual environment. The submission focuses on demonstrating substantial equivalence to a predicate device, SuRgical Planner (SRP) (K170793), rather than presenting a study to prove the device meets specific performance acceptance criteria for a new clinical task.
Therefore, much of the requested information regarding acceptance criteria and performance study specifics (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth detailed establishment for training/test sets) is not applicable or not explicitly detailed in the provided document. The document describes a verification and validation (V&V) plan to confirm the device meets its intended use and performance requirements, implying internal testing rather than a clinical effectiveness study against predefined criteria like sensitivity or specificity.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) or quantitative performance results. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: The SuRgical Planner (SRP) BrainStorm performs its intended functions (image segmentation, 3D model creation, 3D scene display, VR/AR integration, pre-operative planning, surgical training) as described in the device description. | "A formal verification and validation plan was executed to confirm that the SRP BrainStorm meets its intended use and performance requirements." "Verification and validation tests demonstrated the SRP BrainStorm is as safe and effective as the predicate SRP, and performs as intended in the specified use conditions." |
| Safety and Effectiveness Equivalence: The modifications implemented in SRP BrainStorm do not raise any new questions regarding safety and effectiveness compared to the predicate device. | "The differences between the subject and predicate device do not raise any new questions regarding safety and effectiveness." "Based on the information provided in this 510(k) submission, the SRP BrainStorm is considered substantially equivalent to the predicate SRP in terms of fundamental scientific technology." "Any differences between the subject and predicate device do not raise any new concerns regarding safety and effectiveness." |
| Usability/Human Factors: The modifications to the device (e.g., AR support, simplified planner mode features) conform to user needs and the intended use. | "In addition, simulated use human factors and usability validation was performed to validate the modifications conform to the user needs and the intended use of the device." |
| Design Control Compliance: Software design verification and validation testing followed internal design control requirements and methods. | "Software design verification and validation testing was performed per the same internal design control requirements and methods used for the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "a formal verification and validation plan was executed" and "verification and validation tests were performed."
- Data Provenance: Not specified. The source or nature of the data used for the V&V tests (e.g., type of medical images, number of cases, patient demographics, country of origin) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the use of experts to establish ground truth for a test set in the context of a performance study. Given the nature of the device (software interface and planning tool for pre-operative use), the "ground truth" might refer to the accurate representation of anatomical structures or functional software execution, which would be validated internally rather than through expert clinical review against specific diagnostic criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. No adjudication method is mentioned, as there is no description of a performance study involving comparison to a ground truth established by multiple experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned. The device's purpose is not described as an AI-assisted diagnostic tool for human readers but rather as a planning and training tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly detailed, but the context of "verification and validation tests" implies testing of the software's functionality and performance as an algorithm. The device's primary function is a standalone software system for image processing, 3D modeling, and visualization, with human interaction being part of its intended use (e.g., surgeons using VR/AR headsets). It can be inferred that the software's ability to perform its core functions (e.g., segment images, create 3D models) independently was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly defined in the document. For a device like SRP BrainStorm, "ground truth" during verification and validation would likely involve:
- Reference Image Data: Comparing segmented 3D models against known anatomical structures from original medical images.
- Functional Specification Compliance: Ensuring that the software performs its specified functions (e.g., correct import/export, proper 3D rendering, accurate display of electrode detections) as designed.
- Usability/User Interface Testing: Confirming that the user interface and interactions (e.g., with VR/AR headsets) meet design requirements and user expectations for pre-operative planning.
8. The sample size for the training set:
- Not applicable. This device is described as an image processing and visualization tool, not an AI/ML algorithm that is trained on a specific dataset for diagnostic or predictive purposes. The "training" mentioned in the context of the device is for surgical training using the virtual environment, not algorithm training.
9. How the ground truth for the training set was established:
- Not applicable for algorithm training set ground truth. For the surgical training aspect, the "ground truth" is typically the anatomical and physiological accuracy of the virtual environment, which would be established through careful modeling based on medical imaging data and validated by anatomical expertise. However, this is not a training set for the algorithm itself.
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