(44 days)
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:
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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.
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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):
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|
| System Level Accuracy: mean 3D positional error of 2.0mm | Overall system accuracy, including positional accuracy during 2D/3D registration, validated successfully using the same methods and acceptance criteria as the predicate. Performance data (bench) demonstrate accuracy is comparable to the predicate device. |
| System Level Accuracy: mean trajectory error of 2° | Overall system accuracy, including angular accuracy during 2D/3D registration, validated successfully using the same methods and acceptance criteria as the predicate. Performance data (bench) demonstrate accuracy is comparable to the predicate device. |
| Mechanical stability of new components (Patient Marker Extender) | Performance testing demonstrated that the mechanical stability of the Patient Marker Extender assembly meets the same acceptance criteria as the cleared Patient Marker assembly (K241481). |
| Compliance with existing sterilization, cleaning, and transportation standards | Performance tests verified compliance with existing sterilization, cleaning, and transportation standards. |
| Software Functionality, GUI, cybersecurity, HIPAA enhancements | Software changes were validated per FDA guidance and Augmedics' Software Lifecycle Procedure, ensuring the software operates as intended. This includes support for the new component, GUI enhancements for a more intuitive 2D-3D registration process, and cybersecurity and HIPAA enhancements. |
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.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).