(28 days)
The REMI™ Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The REMI™ Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (LI-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider® Spinal System.
The Remi Robotic Navigation System (Remi) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The system operates in a similar manner to other optical-based image y systems.
The provided text outlines the FDA 510(k) clearance for the REMI Robotic Navigation System, focusing on its substantial equivalence to a predicate device. However, it does not contain a detailed study report or explicit acceptance criteria with reported device performance metrics in the format requested.
The document primarily focuses on demonstrating that the updated REMI system, with additional compatible 3D imaging systems, is substantially equivalent to its predicate. The "Performance Testing - Bench" section mentions tests conducted but does not provide specific numerical acceptance criteria or performance results.
Therefore, much of the requested information cannot be extracted directly from the provided text. I will indicate where information is missing or inferred.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Bench) - Worst Case | 0.74 ± 0.36 mm |
| (95% CI: 1.46mm) - This is the reported performance of the predicate device, which the subject device is stated to be "Same as Predicate." | |
| Image Quality (with added 3D imagers) | Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided) |
| Image Transfer Speed (with added 3D imagers) | Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided) |
| Image Registration Speed (with added 3D imagers) | Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided) |
| Registration Accuracy (with added 3D imagers) | Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided) |
| Usability Validation | Testing was done to ensure the risk profile was maintained. (No specific metric or outcome provided) |
| Compatibility with PSIS Pins | Biocompatibility assessment for Ti6Al4V ELI (used in PSIS pins) included in K190360 (referring to a previous clearance for the pedicle screws). |
| Robot collision avoidance/detection | Manual movement of Trajectory Platform to gross location. Small fine tuning of Trajectory Platform location is automatic but is current limited to cease when platform encounters a force greater than 9lbs. (This is for the predicate, and again, the subject device is "Same as Predicate.") |
Study Details from the provided text:
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Sample size used for the test set and the data provenance:
- The document mentions "Performance Testing - Bench" and "Verification and validation testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It suggests bench testing was primarily used for equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information provided. The "performance testing" described appears to be technical validation against specified equivalence factors rather than expert review of clinical outcomes or images.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No information provided.
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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, an MRMC study was not described. This device is a robotic navigation system for spinal surgery, not an AI-assisted diagnostic imaging interpretation tool that would typically involve human readers. Its purpose is to aid surgeons in pedicle screw placement.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document does not explicitly describe a "standalone" algorithmic performance test in the context of an AI-only system. The device is a navigation system that guides a human surgeon. Its performance metrics, like accuracy, are inherently tied to the system's ability to guide to a planned trajectory, which can be measured quantitatively in bench tests. The bench testing mentioned covers aspects like "Accuracy," "Image Quality," "Image Transfer Speed," and "Image Registration Speed."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Based on the description of "Performance Testing - Bench" and "Accuracy verification on anatomical landmarks" (for the predicate), the ground truth for accuracy testing would typically involve precisely measured physical points or targets on a phantom or model, measured by a highly accurate reference system (e.g., CMM). For image quality, transfer, and registration speed, the ground truth would be objectively defined technical specifications or measurements.
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The sample size for the training set:
- No information provided about a "training set." The REMI system is a robotic navigation system, not described as a deep learning or machine learning-based algorithm that typically requires a large training dataset for model development. The system uses pre-programmed logic, image processing, and control algorithms.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML model is mentioned.
§ 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).