(165 days)
The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. The SpineAssist™ System may be used in either open or percutaneous procedures.
The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system, which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge, the Hover-T / Bi-lateral Hover-T bridge, the Bed Mount Hover-T or the Cervical Kit) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools according to the computerized, image-based, pre-operative plan.
The main components of the SpineAssist™ system include:
A. SpineAssist™ device
B. Workstation
C. Accessories including the Clamp Kit for less invasive procedures, the MIS platforms: Hover-T, Bi-lateral Hover-T, Bed Mount Hover-T and the Cervical Kit, the last one intended for less invasive procedures.
Here's an analysis of the provided text regarding the SpineAssist™ System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test / Requirement | Reported Device Performance / Outcome |
|---|---|---|
| Stability | Bed Mount Hover-T Stability Test | Performed, intent to validate stability |
| Relative Movement of C2 Test | Performed, intent to validate stability | |
| Cervical Bridge Rigidity Test | Performed, intent to validate stability | |
| Bi-lateral Hover-T Rigidity Test | Performed, intent to validate stability | |
| Accuracy | Cervical Accuracy C1-C6 Test | Performed, intent to validate accuracy |
| Bed Mount Hover-T Accuracy T6-T12 | Performed, intent to validate accuracy | |
| Software Validation | Software Validation (IEC 60601-1-4 & FDA Guidelines) | Meets design and performance specifications |
| Biocompatibility | Biocompatibility Testing (ISO 10993) | Complies with standard |
| Overall Conclusion | Safety and Effectiveness | System may be safely and effectively used; substantially equivalent to previously cleared devices. |
Note: The document states that the performance tests "demonstrate that SpineAssist system meets its design and performance specifications." However, it does not provide specific quantitative acceptance criteria or detailed results for each test (e.g., "accuracy within X mm"). It only indicates that these tests were performed to validate stability and accuracy for the extended intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The document mentions tests were performed "on cadavers to simulate real clinical procedures." The number of cadavers used is not specified.
- Data Provenance: The cadaver tests were described as simulating clinical procedures, but the origin of the cadavers (e.g., country) is not mentioned. These were non-clinical tests. The study is prospective as it involved performing tests to gather data for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the given text. The tests were "stability and accuracy tests... performed on cadavers," implying a technical assessment rather than a human expert consensus for "ground truth" related to device performance metrics.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. The performance tests described (stability, accuracy) are typically measured objectively by technical instrumentation rather than requiring a human adjudication process like in a diagnostic study.
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. This submission is for a surgical navigation system, not an AI-assisted diagnostic tool. There is no mention of human readers or AI assistance in a diagnostic context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, standalone (algorithm/device only) performance tests were done. The "Non-Clinical Performance Data" section describes various stability and accuracy tests performed on the SpineAssist™ system itself (e.g., "Bed Mount Hover-T Stability Test," "Cervical Accuracy C1-C6 Test"). These tests evaluate the device's technical specifications without necessarily involving human surgical performance in a comparative study. The software validation is also a standalone assessment of the algorithmic components.
7. The Type of Ground Truth Used
- For the accuracy and stability tests, the ground truth would likely be established through pre-defined anatomical landmarks or precise measurements taken by a high-precision measurement system (e.g., optical tracking, CMM). For example, in an "accuracy" test, the deviation of the navigated tool from a known target trajectory or point would be measured against a gold standard reference. The text doesn't explicitly state the methodology for establishing this ground truth but implies it's based on physical measurements and engineering specifications.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. The SpineAssist™ system is described as a "computer controlled miniature medical image-guided surgery (IGS) system" that processes images and exports coordinates. While it uses "proprietary algorithms," it is not described as a machine learning or AI system that requires a distinct "training set" to develop its core functionality in the sense that a diagnostic AI model would. Its software validation focuses on compliance with standards rather than a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided for the reasons stated in point 8.
§ 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).