(408 days)
The Neo ADVISE™ System is indicated to calculate the relative positions and distances between implanted Neo Pedicle Screw System™ screws, as estimated by visually identifying screw guides, to estimate rod length, visualize rod positioning, and create a rod template that can be used to visually guide the manually creation a contoured rod by the surgeon, with a mechanical rod bender. The Neo ADVISE™ System can be used in posterior open or percutaneous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™.
The Neo ADVISE system is a tool that supports the surgeon in open and percutaneous spinal surgeries performed with the Neo Medical Pedicle Screw System (K222256). After the placement of the pedicle screws, the software scans the the screw head positions and shows them in Augmented Reality (AR) on an iPad. Based on the scanned screw positions, the software displays the distance between the screw heads and calculates the minimum rod length. The surgeon can select any of the pre-bent or straight rods of the Neo PSS and check the placement of the rod in the patient's body without touching the body or taking X-Ray images. The software calculates the distance between the screw head and the rod in the coronal and sagittal plane for the selected rod, indicating possible screw head adjustments.
Again, based on the scanned screw position, the software can generate a custom bent rod template that follows the path through all screw heads. This provides the surgeon with a rod template that assists the surgeon in rod bending. The rod template is displayed in a 1-1 scale on the device in the sagittal and coronal plane, allowing the surgeon to copy the rod shape according to the template.
The scanning of the screw heads can be performed using two distinct scanning methods, 3D scanning and Marker detection. 3D Scanning does not require any additional hardware. The surgeon scans each guide separately by overlaying the physical guide with a virtual guide in AR. 3D Scanning of the guides is limited to 10 guides. The Marker Detection scanning method allows the scanning of up to 20 guides. This is achieved by the use of the Neo Markers and the Neo Marker Base. The Neo Markers are attached to each guide, providing the software with a defined pattern, similar to QR codes, that can be recognized by the software.
The Neo ADVISE System consists of several components. The software runs on an Apple iPad, which is put into a sterile bag to allow use in the sterile environment of the patient's area. The Neo Markers and the Neo Marker Base are needed to allow the scanning of the guides using the Marker Detection scanning method.
The provided documentation is a 510(k) summary for the Neo ADVISE System. It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and performance study results typically found in a full submission. Based on the provided text, I can infer some aspects and highlight what information is missing.
Here's an attempt to answer your request based solely on the provided text, noting limitations:
Device: Neo ADVISE System
The Neo ADVISE System is a software tool intended for use in posterior open or percutaneous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™. Its functions include:
- Calculating relative positions and distances between implanted Neo Pedicle Screw System™ screws.
- Estimating rod length.
- Visualizing rod positioning.
- Creating a rod template to visually guide the manual creation of a contoured rod by the surgeon with a mechanical rod bender.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria or a table of performance metrics. The performance data presented is qualitative and focuses on the efficacy and usability of the system in cadaveric studies, rather than precise accuracy metrics against a predefined acceptance threshold.
Inferred Performance/Acceptance based on study description:
| Acceptance Criteria (Inferred) | Reported Device Performance (from text) |
|---|---|
| Accuracy of Screw Head Position/Distance Calculation | The first cadaver study involved inserting 6 polyaxial pedicle screws (Neo Pedicle Screw System™) percutaneously at levels L1-S1 on one side of the spine. The software calculates distances and positions based on scanned screw heads. No specific quantitative accuracy metric (e.g., in mm) is provided. |
| Effectiveness in Rod Length Estimation/Rod Positioning Visualization | The second cadaver study aimed to assess the "accuracy and effectiveness of the Neo ADVISE™ System in assembling and fixing posterior screw-rod constructions." It also looked at "translation of screw heads along sagittal and transverse axes, as well as angular change (Cobb angle) along sagittal and coronal planes." No specific quantitative thresholds or results are provided. |
| Effectiveness in Rod Template Generation guidance | The system generates a custom bent rod template. The document states a study demonstrating "AR-guided surgery maintained anatomy during rod placement and fixation." No quantitative data on the precision of the generated template or resulting rod contour is available. |
| Usability and Human Factors | "The usability studies... focused on identifying preventable errors attributable to device design or labeling and affirmed the usability of the Neo ADVISE™ system." No specific usability metrics (e.g., task completion rates, error rates) are provided. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Sets:
- Cadaver Study 1: Single human cadaveric spine specimen. (Specific number of "cases" or distinct surgical scenarios not explicitly detailed beyond 6 screws across 5 levels).
- Cadaver Study 2: Number of cadaveric specimens not explicitly stated, but implies multiple procedures to assess "assembling and fixing posterior screw-rod constructions."
- Usability Studies: Not specified, but described as a "usability study including a follow-up study."
- Data Provenance: The cadaver studies were conducted in Germany ("11 German orthopedic and trauma surgeons," "Four German spine surgeons"). The studies appear to be prospective, laboratory-based evaluations.
- Test Sets:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cadaver Study 1: 11 German orthopedic and trauma surgeons. Qualifications: No further detail beyond "orthopedic and trauma surgeons."
- Cadaver Study 2: 4 German spine surgeons. Qualifications: No further detail beyond "spine surgeons."
- Ground Truth Establishment: The document does not describe a formal consensus-based ground truth establishment process by these experts for the system's output accuracy. Instead, the experts used the device and their observations/measurements (e.g., CBCT scans for screw head translation and Cobb angle in Cadaver Study 2) served as a basis for assessing the system's performance. For usability, the experts were the users being observed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any formal adjudication method for establishing ground truth or resolving discrepancies in performance measurements. The studies appear to be observational with metrics derived from post-procedure assessments (e.g., CBCT).
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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 study described for comparative effectiveness with vs. without AI assistance. The studies focus on evaluating the Neo ADVISE system itself, not a direct comparison of human performance with and without its aid. The design is more akin to a device validation study where the device functionality is assessed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is intended as an intraoperative tool to assist the surgeon ("supports the surgeon," "assists the surgeon"). The performance data described is based on studies where the device is used by surgeons in a human-in-the-loop scenario.
- While the software performs calculations (e.g., rod length, template generation) on its own, the overall system's performance naturally includes the human interaction (scanning screw guides, interpreting AR display). There's no explicit mention of a "standalone" algorithmic performance evaluation separate from human interaction, which would be difficult given its indicated use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cadaver Studies: The primary ground truth for measuring accuracy (e.g., screw head position, rod fit) during the cadaver studies appears to be derived from CBCT (Cone-beam computed tomography systems) scans. This is an anatomical imaging-based ground truth.
- Usability Studies: Ground truth for usability would typically come from observed user interactions, error logging, and user feedback, evaluated against pre-defined usability goals.
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The sample size for the training set:
- Not provided. The document describes non-clinical testing data, but provides no information about the development or training of the AI algorithms (if any, beyond general "proprietary algorithms" mentioned in comparison to the predicate). It's possible the algorithms are rule-based or derived from geometric principles rather than machine learning models requiring large training sets.
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How the ground truth for the training set was established:
- Not provided. As the training set size and specifics of the AI/algorithms are not disclosed, neither is the method for establishing their ground truth (if applicable).
Overall Limitation: The provided FDA 510(k) summary is a high-level overview. It typically minimizes detailed performance statistics and focuses on demonstrating substantial equivalence. For a comprehensive understanding of acceptance criteria and detailed study results, one would need to review the full 510(k) submission, which is not publicly available in this snippet.
§ 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).