(90 days)
The HOLO Portal™ Surgical Guidance System is indicated as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.
The HOLO Portal™ Surgical Guidance System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D 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 HOLO Portal™ System is a combination of hardware and software that provides visualization of the patient's internal anatomy and surgical guidance to the surgeon based on patient-specific digital imaging.
HOLO Portal™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The HOLO Portal™ System consists of two mobile devices: 1) the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy, compared to traditional two-dimensional (2D), displays during surgical procedures.
The provided text describes the acceptance criteria and the study conducted for the HOLO Portal™ Surgical Guidance System, primarily focusing on performance testing. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "positional error must be less than X mm"). Instead, the document refers to "worst-case" measurements and relies on clinical meaningfulness relative to the predicate. The performance data is summarized in tables.
| Metric | Performance Validation (Cadaver) - Mean | Performance Validation (Cadaver) - Standard Dev. | Performance Validation (Cadaver) - 95% CI Upper Bound | Performance Validation (Cadaver) - 99% CI Upper Bound | Performance Verification (Benchtop) - Mean | Performance Verification (Benchtop) - Standard Dev. | Performance Verification (Benchtop) - 95% CI Upper Bound |
|---|---|---|---|---|---|---|---|
| Positional Error [mm] | 2.37 | 0.72 | 2.58 | 2.69 | 1.54 | 0.74 | 1.75 |
| Angular Error [degrees] | 1.40 | 0.84 | 1.65 | 1.73 | 1.50 | 0.68 | 1.69 |
Acceptance Criteria Implied: The device must meet "performance requirements under the indications for use" and demonstrate "equivalent safety and efficacy of the system to the cited predicate device." The provided numbers represent the achieved performance, which is presumably within acceptable limits for its intended use and considered substantially equivalent to the predicate. No explicit numerical acceptance thresholds are provided in the text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of cadavers or benchtop phantoms used. It mentions "surgical simulations conducted on cadavers" and "rigid benchtop phantoms." It refers to "a set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans" for software validation. The number of measurements (which would be related to the sample size of "pedicle screws" or placements) is not provided.
- Data Provenance: The document does not specify the country of origin for the data. The studies are described as "surgical simulations conducted on cadavers" and "rigid benchtop phantoms," and testing for software validation used "extracted from stationary and intraoperative Computed Tomography scans." It is retrospective in the sense that the CT scans for software segmentation were "extracted," but the practical "performance validation" and "verification" studies appear to be prospective experimental setups (cadaver labs, benchtop testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: For the software validation study of anatomical segmentation, the ground truth was established by "manual segmentations prepared by trained analysts." The specific number of analysts is not provided.
- Qualifications of Experts: The experts are simply described as "trained analysts." No specific qualifications (e.g., radiologist, years of experience) are mentioned.
4. Adjudication Method for the Test Set
- For the software validation (segmentation comparison), an adjudication method is not explicitly stated. The comparison was based on "mean Sørensen-Dice coefficient (DSC) calculations" against manual segmentations. This implies a direct quantitative comparison rather than a human-based adjudication process for discrepancies.
- For the positional and angular error measurements in cadaver and benchtop testing, "the 3D (Euclidean) distance between the tips of the virtual and real implants" and "the angle between the 3D trajectories of the virtual and real implants" were measured. This is an objective measurement, not requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was not explicitly mentioned or described in the provided text. The device is a surgical guidance system, not an AI for image interpretation that would typically involve a diagnostic reader study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, aspects of standalone performance were conducted:
- Positional and Angular Error (Cadaver and Benchtop): These measurements assess the system's accuracy in tracking and guiding, which is a standalone performance metric of the system itself in a controlled environment.
- Software Validation (Segmentation): "A set of test samples presenting lumbosacral spine... was subjected to the autonomous spine segmentation process performed by the HOLO Portal System." The quality was determined by comparing the system's segmentation to manual ground truth. This is a clear example of standalone algorithm performance testing.
7. The Type of Ground Truth Used
- For Positional/Angular Error (Cadaver and Benchtop): The ground truth was based on the "real implants" or "real pedicle screws" placed, with measurements taken relative to these physical realities. This could be considered a form of objective measurement against physical reality.
- For Software Segmentation: The ground truth was "manual segmentations prepared by trained analysts." This is expert consensus/manual annotation based ground truth.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set of the HOLO Portal™ Surgical Guidance System's software, including the autonomous spine segmentation process.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. It only describes the establishment of ground truth for the test set (manual segmentations by trained analysts).
§ 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).