(262 days)
The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar 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 or implants 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 or the Hover-T bridge) 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 or implants according to the computerized, image-based, preoperative plan.
The main components of the SpineAssist™ system include:
- A. SpineAssist™ device
- B. Workstation
- A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt (e.g., specific quantitative benchmarks for acceptance, detailed performance metrics with numerical results, sample sizes for test and training sets, expert qualifications, or adjudication methods).
However, based on the summary of non-clinical performance data and conclusions, I can infer the general acceptance criteria and report the mentioned performance.
Here's an analysis of what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly suggests that the system's performance for "accuracy" and "safety and effectiveness" during "general spinal surgical procedures" were the key criteria.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safe and Effective for general spinal surgical procedures | Performance tests demonstrate that SpineAssist system may be safely and effectively used in general spinal surgical procedures. |
| Meets design and performance specifications | Software validation and accuracy performance tests demonstrate that the SpineAssist system meets its design and performance specifications. |
| Substantial Equivalence to predicate devices (original SpineAssist™ and StealthStation System) | The system is found to be substantially equivalent to the predicate devices. |
| Compliance with relevant standards | Complies with IEC 60601-1-4 (Software Validation) and ISO 10993 (Biocompatibility Testing). |
| Demonstrates "precision" in guiding instruments/implants | Indicated for "precise positioning of surgical instruments or implants." |
| Accuracy in new imaging scenarios | "New Imaging and Lateral to 30 degree Accuracy Test" completed. |
| Accuracy with Hover-T and Prisms | "Hover-T Accuracy Test Results Report" and "Use of Prisms in Translaminar Facet Cases Study" completed. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "non-clinical performance data" and lists several "case studies" and "accuracy tests." It does not specify the sample size (e.g., number of cases, number of measurements) for any of these tests.
The data provenance is not explicitly stated. However, given the nature of "non-clinical performance data" for a surgical device involving "accuracy tests" and "case studies," it is highly likely that these were conducted in a controlled laboratory or cadaveric setting, rather than on human patients (since "Clinical Performance Data" is marked as "Not Applicable"). It is likely prospective for the specific tests conducted for this submission. The company is based in Israel, so the studies were likely conducted there or in a partnered facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the "accuracy tests" or "case studies."
4. Adjudication Method for the Test Set
The document does not provide any information regarding adjudication methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this summary. The device is a surgical navigation system, not an AI diagnostic tool that assists human readers in interpreting medical images. "Clinical Performance Data" is explicitly stated as "Not Applicable," further reinforcing that human reader studies are outside the scope of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the "Non-Clinical Performance Data" listed are all standalone algorithm/system performance tests. The device itself is designed to guide surgical tools based on algorithmic processing of imaging data, and the tests like "General Spinal Accuracy Test," "Hover-T Accuracy Test," and "New Imaging and Lateral to 30 degree Accuracy Test" directly assess the system's performance in this standalone capacity. The lack of "Clinical Performance Data" and MRMC studies further supports that the reported performance reflects the algorithm/system without human-in-the-loop performance for this specific submission.
7. The Type of Ground Truth Used
While not explicitly stated, for "accuracy tests" in a surgical navigation system, the ground truth would typically be established by:
- Precise measurements using highly accurate calibration tools or coordinate measuring machines in a controlled environment (e.g., phantom, cadaveric models).
- Known physical dimensions or fiducial markers on phantoms or cadavers which the system is attempting to target or guide to.
- For "case studies" (e.g., Osteoid Osteoma, Thoracic Hover-T), the "ground truth" might refer to the actual anatomical position or intended trajectory as confirmed by intra-operative imaging or post-operative assessment against the surgical plan.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how the ground truth for the training set was established.
§ 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).